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Ongoing Clinical Trials
The following is a list of clinical trials currently available in Hawaii. The studies are listed by disease site followed by the name of the cooperative group and study number, eligibility required for each study and the treatment for the study. Studies are generated by Cancer Research Center of Hawaii investigators, National Cancer Institute (NCI) sponsored cooperative groups or industry (pharmaceutical companies).
We currently participate with eight major cancer cooperative groups. These regional and national groups are networks of institutions and investigators at academic hospitals, community hospitals and medical practices that voluntarily work together to conduct cancer research. Most cancer patients on clinical trials in Hawaii are enrolled in cooperative group studies.
| Type of Cancer | Group/Study No. | Basic Eligibility | Basic Treatment Plan | Phase |
| Brain | ||||
| Glioblastoma multiforme | RTOG 0525 | ≥ 18 years old. Has undergone surgery to remove the tumor within the past 5 weeks. No recurrent glioma. No previous chemotherapy or Gliadel wafer therapy for head and neck cancer. | Study comparing two schedules of temozolomide to compare how well they work when given together with radiation therapy in treating patients with newly diagnosed glioblastoma multiforme. | III |
| Breast | ||||
| Premenopausal - Ovarian suppression (SOFT trial) | IBCSG 24-02 | No more than 6 months since chemotherapy. No distant metastases. Cancer in one breast only. No previous breast cancer. No previous radiation therapy to ovaries. No previous surgery to remove the ovaries. | 3 arm Suppression of Ovarian Function Trial (SOFT). 1) Tamoxifen alone. 2) Ovarian Function Suppression (Triptorelin, surgical oophorectomy, and Ovarian irradiation) + Tamoxifen. 3) Ovarian Function Suppression + Exemestane. | III |
| DCIS - Partial Breast RT | NSABP B-39 | ≥ 18 years old. Has undergone surgery to remove the tumor. No Paget's disease of the nipple. No previous radiation therapy to the breast or chest. | Whole Breast Radiation Therapy vs. Partial Breast Radiation Therapy. | III |
| Neo-Adjuvant Aromatase Inhibitor | ACOSOG Z1031 | Measurable disease. No inflammatory breast cancer. Estrogen receptor positive tumor. No previous radiation therapy, hormone therapy, or chemotherapy for breast cancer. | This randomized phase III trial is studying exemestane, letrozole, and anastrozole to compare how well they work in treating postmenopausal women who are undergoing surgery for stage II or stage III breast cancer. | III |
| Neo-Adjuvant | NSABP B-40 | At least 18 years old. HER2-negative disease. No previous excisional biopsy or incisional biopsy for primary breast tumor. No breast cancer in both breasts. No previous breast cancer or ductal carcinoma in situ. | This study is being done to find how well six different chemotherapy regimens compare when working with or without bevacizumab in treating women with stage I, stage II, or stage IIIA breast cancer that can be removed by surgery. | III |
| Treatment or Randomization by Recurrence Score (RS) Oncotype | PACCT-1 / TAILORx | 18-75 years old. Estrogen receptor (ER)-positive and/or progesterone receptor (PR)-positive tumor. HER2/neu negative tumor. Has undergone surgery to remove the tumor within the past 3 months. No previous chemotherapy or radiation therapy for this cancer. | This study is being done to find out the best individual therapy for women who have node-negative, estrogen-receptor positive breast cancer by using a special test (Oncotype DX), and whether hormone therapy alone or hormone therapy together with combination chemotherapy is better for women who have an Oncotype DX recurrence score of 11-25. | |
| Breast - Negative Node | NSABP B-36 | Invasive breast cancer with negative axillary nodes, any Estrogen and Progesterone, 84 days from last surgery. | Doxorubicin and cyclophosphamide (AC) × 4 vs. FEC (epirubicin) × 6. Epirubicin is provided. | III |
| Breast - Positive Node or High Risk Negative Node | SWOG S0221 | ≥ 18 years old. Enroll before 84 days from surgery for this cancer. No previous chemotherapy or radiation therapy for this cancer. ≥ 2 weeks since radiation therapy for ductal carcinoma in situ. | 4 chemotherapy regimes being compared. 1) AC + pegfilgrastim followed by Paclitaxel + pegfilgrastim. 2) AC + G-CSF followed by Paclitaxel + pegfilgrastim. 3) AC + pegfilgrastim followed by Paclitaxel. 4) AC + G-CSF followed by Paclitaxel. | III |
| High Risk Node Negative | CALGB 40101 | ≥ 18 years old. No previous chemotherapy or trastuzumab for this cancer. No more than 12 weeks since surgery to remove the tumor. | This study is being done to see how well cyclophosphamide and doxorubicin work compared to paclitaxel in treating women with invasive breast cancer. | III |
| Postmenopausal. ER/PR(+). Completed 5 years of Hormonal Treatment | NSABP B-42 | Stage I, II, or IIIA primary breast cancer. Received hormone therapy for 5 years after diagnosis of breast cancer. No more than 6 months since finishing hormone therapy. Has undergone lumpectomy and radiation therapy to the breast or total mastectomy. | This randomized phase III trial is studying letrozole to see how well it works compared with a placebo in treating postmenopausal women who have received hormone therapy for hormone receptor-positive breast cancer. | III |
| Local/Regional Relapse | NSABP B-37 | Any age. No distant metastases. | Two-arm study being done to find the effectiveness of chemotherapy for patients who have undergone a resection for breast cancer. 1) Observation +/- Radiation therapy. 2) chemotherapytherapy +/- radiation therapy. | III |
| Advanced Breast (postmenopausal) | SWOG S0226 | No CNS metastases. More than one year since chemotherapy, anastrozole, letrozole, or exemestane. No previous fulvestrant. | Hormonal drugs anastrozole + fulvestrant vs anastozole alone. Fulvestrant provided. | III |
| Cytoxan PO + Capecitabine | SWOG S0430 | ≥ 18 years old. At least 2 weeks since surgery. | This study is being done to find how well giving cyclophosphamide together with capecitabine works in treating women with stage IV breast cancer. | II |
| Cancer Control and Prevention - Behavioral and Quality of Life Issues | ||||
| Focus Group for Quality of Life Issues Culturally Appropriate? | CRCH C0700 | |||
| Cancer Control and Prevention - Chemo-Prevention | ||||
| Lung | SWOG E5597 | ≥ 18 years old. ≥ 6 months, but not more than 3 years, since surgery to remove lung tumors. No evidence of lung cancer after surgery. No previous chemotherapy or radiation therapy for lung cancerpy or radiation therapy for lung cancer. | Two arm study being done to find the effectiveness of selenium in preventing the development of second primary lung tumors. 1) Selenium orally once a day. 2) Placebo orally once a day. | III |
| Cancer Control and Prevention - Symptom Control | ||||
| Nausea | URCC U1902 | ≥ 18 years old. Scheduled to receive chemotherapy with no planned interruption by radiation therapy. Experienced nausea after completing the first course of chemotherapy. ≥ 6 months since other chemotherapy. | Phase II/III study of ginger capsules in controlling chemotherapy-related nausea. | II/ III |
| Gastrointestinal Tract | ||||
| Colon | ECOG E5202 | ≥ 18 years old. Has undergone surgery to remove the tumor. More than 4 weeks since surgery. | Three arm study comparing two regimens of combination chemotherapy. 1) oxaliplatin, leucovorin, 5 fluorouracil, and bevacizumab. 2) oxaliplatin, leucovorin, and 5 fluorouracil. 3) observation only | III |
| Colon | NCCTG N0147 | ≥ 18 years of age. No rectal cancer. No more than 8 weeks since surgery to completely remove the tumor. No distant metastases. No previous chemotherapy or radiation therapy for colon cancer. | A phase III study of standard chemotherapy (FOLFOX) with and without a new drug cetuximab (Erbitux). | III |
| Colorectal Locally advanced or Metastatic | CALBG 80405 | ≥ 18 years of age.No CNS metastases. No previous bevacizumab or cetuximab. ≥ 4 weeks since radiation therapy or surgery. | This study is being done to compare cetuximab and bevacizumab when given together with combination chemotherapy to see how well they work in treating patients with metastatic colorectal cancer. | III |
| Gastric or Gastroesophageal junction (GE) | CALGB 80101 | ≥ 18 years old. No metastatic cancer. No previous chemotherapy or radiation therapy. No more than 8 weeks since surgery. | This study is being done to compare two different chemotherapy plus radiation regimes in treating patients who have undergone surgery for stomach or esophageal cancer. 1) Leucovorin calcium IV and 5-FU. 2) Epirubicin IV and cisplatin IV. | III |
| Esophageal or GE junction Pre-op |
SWOG S0356 | ≥ 19 years old. No recurrent cancer. No previous chemotherapy, radiation therapy, or surgery for esophageal cancer. | This phase II trial is studying how well giving oxaliplatin together with fluorouracil and radiation therapy works in treating patients who are undergoing surgery for stage II or stage III cancer of the esophagus or gastroesophageal junction. | II |
Pancreas |
≥ 18
years old. Has undergone surgery to completely remove the tumor within the past 4-8 weeks. No metastatic cancer. No previous chemotherapy or radiation therapy for this cancer. |
This study is being done to find how well bevacizumab works compared to cetuximab when given together with gemcitabine, capecitabine, and radiation therapy in treating patients with pancreatic cancer that has been completely removed by surgery. |
III |
|
| Colon | NSABP C-10 | ≥ 18 years old. Has primary tumor that is asymptomatic. No CNS metastases or rectal cancer. No previous chemotherapy, radiation therapy, or surgery for this cancer. More than 4 weeks since surgery or open biopsy. | This study is being done to find out how well giving combination chemotherapy together with bevacizumab works in treating patients with stage IV colon cancer that cannot be removed by surgery. | II |
| Rectum | NSABP R-04 | No metastatic disease. No previous radiation therapy to the pelvis. | This study is being done to find the effectiveness of combining radiation therapy with either capecitabine or 5-fluorouracil before surgery in treating patients who have operable rectal cancer. 1) RT (radiation therapy) + 5-FU. 2) RT + Capecitabine. | III |
| Rectum | ≥ 18 years old. Has undergone surgery to completely remove the tumor within the past 4-8 weeks. Received chemotherapy and radiation therapy before undergoing surgery. No other previous chemotherapy or radiation therapy to the pelvis. | This randomized phase III trial is studying combination chemotherapy to see how well it works with or without bevacizumab in treating patients who have had surgery for stage II or stage III rectal cancer. | III |
|
| Genitourinary | ||||
| Superficial Bladder Cancer | ≥ 18 years old. Cancer did not respond to at least two courses of BCG within the past 3 years. Has undergone surgery to remove the tumor or biopsy within the past 2 months. No previous gemcitabine. | This study is being done to find how well gemcitabine works in treating patients with recurrent bladder cancer that has failed previous Bacillus Calmette-Guerin (BCG). | II |
|
| Prostate Cancer, High risk features (PSA, Gleason score) | RTOG 0521 | ≥ 18 years old. Prostate-specific antigen (PSA) no greater than 150 ng/mL. No distant metastases. No previous prostatectomy, cryosurgery for prostate cancer, or bilateral orchiectomy. No previous chemotherapy for prostate cancer. | This study is being done to find how well hormone therapy and radiation therapy followed by docetaxel and prednisone to see how well it works compared to hormone therapy and radiation therapy in treating patients with localized prostate cancer. 1) androgen suppression therapy + oral antiandrogen. 2) Same as arm I + docetaxel IV. | III |
| Prostate, metastatic to bone or soft tissue (stage D2) | SWOG 9346 | May have started anti-androgen therapy. More than 1 year since hormone therapy. No previous surgery to remove both testicles. | This two arm study is being done to find if continuous or intermittent anti-androgen therapy works better after an initial response. | III |
| Prostate, Hormone - refractory | CALGB 90401 | ≥ 18 years old. Cancer no longer responds to hormone treatment (hormone-refractory). No brain metastases. ≥ 4 weeks since hormone therapy, radiation therapy, or surgery. No previous angiogenesis inhibitors. No previous chemotherapy. | This study compares the benefit of standrad chemotherapy (docetaxel and prednisone) with and without a new drug, bevacizumab (Avastin). | III |
| Prostate with Bone metastases | CALBG 90202 | ≥ 18 years old. More than 1 year since hormone therapy that lasted no more than 6 months. No more than 3 months since starting current androgen deprivation therapy. At least 4 weeks since radiation therapy. No previous bisphosphonates. | This study is being done to find how well zoledronate works in preventing bone-related events in patients who are receiving androgen deprivation therapy for prostate cancer and bone metastases. | III |
| Renal Cell | Has undergone surgery to remove the kidney within the past 3-10 weeks or planning to undergo surgery to remove the kidney. Planning to start study treatment 4-12 weeks after surgery to remove the kidney. No distant metastases. | This three arm study is being done to find how well sunitinib works compared to sorafenib or placebo in treating patients with kidney cancer that has been removed by surgery. | III |
|
| Gynecologic | ||||
| Cervical | GOG-0219 | ≥ 18 years old. No previous treatment for cervical cancer. No previous hysterectomy. No previous coronary artery bypass surgery. | This two arm study is comparing the effectiveness of a new treatment to the standard treatment in treating patients with cervical cancer. 1) cisplatin + radiation therapy + tirapazamine. 2) cisplatin + radiation therapy | III |
| Endometrial. Stage III, IV or recurrent | GOG-0209 | ≥ 18 years old. No previous chemotherapy. ≥ 4 weeks since radiation therapy to the whole pelvis. | This two arm study is comparing the effectiveness of a new treatment to the standard treatment in treating patients with cancer of the endometrium. 1) Doxorubicin + Cisplatin + 3-hour Paclitaxel + G-CSF. 2) Carboplatin + 3-hour Paclitaxel. | III |
| Endometrial. Recurrent or metastatic | GOG-0188 | Measurable disease. At least 3 weeks since hormone therapy, radiation therapy, or surgery. | This study is being done to find how effective fulvestrant is in treating patients with recurrent, persistent, or metastatic endometrial cancer. | II |
| Ovarian ca Risk-reducing Surgery Main Bone Mineral Density (BMD) | GOG-0215 | ≥ 30 years old. At increased genetic risk of ovarian cancer. No previous ovarian cancer. > 6 weeks since dental or jaw surgery. No previous tamoxifen or raloxifene. No previous treatment for osteoporosis. > 1 month since radiation therapy or chemotherapy. | This study is being done to find how well zoledronate works compared to observation in maintaining bone mineral density in patients who are undergoing risk-reducing surgery to remove both ovaries. | |
| Ovarian. Stage III, IV suboptimal, residual | GOG-0218 | ≥ 18 years old. Has undergone surgery for this cancer within the past 12 weeks. No primary brain tumor or brain metastases. No previous bevacizumab. No previous chemotherapy for abdominal or pelvic cancer. No previous hormone therapy for this cancer. | This 2 arm study is comparing the effectiveness of carboplatin, paclitaxel, and bevacizumab against the effectiveness of carboplatin, paclitaxel, and a placebo in treating patients with stage III or stage IV ovarian epithelial, primary peritoneal, or fallopian tube cancer. | III |
| Ovarian. Stage III, IV. No disease after chemotherapy. | GOG-0212 | Has undergone surgery for ovarian epithelial or peritoneal cancer. Must have received at least 5, but no more than 8 courses of combination chemotherapy within the past 6 weeks. No symptoms of cancer after previous platinum and taxane therapy. No previous radiation therapy to the abdomen or pelvis. | This study is being done to compare the effectiveness of 3 different treatments for patients who have stage III or IV ovarian cancer. 1) Paclitaxel. 2) Polyglutamate paclitaxel. 3) Observation only. | III |
| Ovarian Stromal | GOG-0187 | Measurable disease. No previous radiation therapy to the tumor. | This study is being done to find the effectiveness of paclitaxel in treating patients who have ovarian stromal cancer. | II |
| Ovarian | GOG-0146O | 18-85 years of age. Measurable disease. Received one previous chemotherapy regimen that contained cisplatin or carboplatin. No previous bone marrow or stem cell transplantation. At least 3 weeks since biological therapy, chemotherapy, or radiation therapy | This study is being done to find the effectiveness of irofulven in treating patients who have recurrent or persistent ovarian epithelial cancer or primary peritoneal cancer. | II |
| Uterine Carcinosarcoma | GOG-0130E | Any age. Measurable disease. At least 3 weeks since biological therapy for this cancer. Received only one previous chemotherapy regimen for this cancer. No previous docetaxel or gemcitabine. | This trial is studying how well giving gemcitabine together with docetaxel works in treating patients with recurrent or persistent uterine cancer. | II |
| Head and Neck | ||||
| Leukemia | ||||
| Lung | ||||
| NSC Lung | SWOG S0424 | Has smoked less than 100 cigarettes in a lifetime, has not smoked for at least 1 year, or currently smokes. No previous chemotherapy or radiation therapy. At least 18 years old. | This trial is studying carcinogens in lung tissue from smokers and non-smokers with newly diagnosed stage I, stage II, or stage III non-small cell cancer. | |
| NSC Lung | CRCH 0503 | III |
||
| NSC Lung | SWOG E5597 | ≥ 18 years old. At least 6 months, but no more than 3 years, since surgery to remove lung tumors. No evidence of lung cancer after surgery. No previous chemotherapy or radiation therapy for lung cancer. | This study is being done to find the effectiveness of selenium in preventing the development of second primary lung tumors in patients who have undergone surgery to remove stage I non-small cell lung cancer. | III |
| Lymphoma | ||||
| Mantle Cell | Stage II, stage III, or stage IV mantle cell lymphoma. No previous treatment for this cancer. Measurable disease. No CNS lymphoma. No previous chemotherapy, radiation therapy, or antibody therapy for lymphoma. | This trial is studying how well giving rituximab together with combination chemotherapy and bortezomib followed by bortezomib alone works in treating patients with newly diagnosed mantle cell lymphoma. | III |
|
| Non-Hodgkins Lymphoma (NHL). Low Tumor Burden. | ECOG E4402 | ≥ 18 years old. Measurable disease. No previous biological therapy, chemotherapy, or radiation therapy for lymphoma. | This study is being done to compare two different combination chemotherapy regimens and to find This study is being done to compare two different schedules of rituximab and to find out how well they work in treating patients with low tumor burden indolent stage III or IV non-Hodgkin's lymphoma. 1) Rituximab IV once a week for 4 weeks. 2) Rituximab IV once every 12 weeks. | III |
| Non-Hodgkins Lymphoma (NHL). Diffuse. | SWOG S0515 | ≥ 60 years old. Measurable disease. No CNS lymphoma. No previous chemotherapy, radiation therapy, or therapy with antibodies for this cancer. More than 4 weeks since surgery. No previous organ transplant. | This study is being done to find how well giving combination chemotherapy with rituximab and bevacizumab works in treating older patients with stage II, III, or IV diffuse large B-cell lymphoma. | II |
| Non-Hodgkins Lymphoma (NHL), Follicular | SWOG S0016 | ≥ 18 years old. Measurable disease. No more than 6 weeks since biopsy. No CNS involvement. No previous monoclonal antibody therapy for cancer. No previous chemotherapy or radiation therapy for lymphoma. | This study is comparing 2 different monoclonal antibodies given with combination chemotherapy to find out how well they work in treating patients with newly-diagnosed non-Hodgkin's lymphoma. 1) CHOP only. 2) CHOP + rituximab. 3) CHOP + tositumomab. | III |
| Non-Hodgkins Lymphoma (NHL), Autologus stem cell transplant. | SWOG S9704 | 15-65 years old. Measurable disease. No CNS lymphoma. No previous radiation therapy for lymphoma. No previous radiation therapy to the chest. | This study is comparing chemoradiotherapy and peripheral stem cell transplantation to see how well they work compared to combination chemotherapy in treating patients with stage II, III, or IV non-Hodgkin's lymphoma. 1) CHOP 2)CHOP + additional course of CHOP + filgrastim (G-CSF). | III |
| B-cell Lymphoma | SWOG S0520 | ≥ 18 years old. Measurable disease. No more than 3 previous chemotherapy regimens. At least 2 weeks since valproic acid or radiation therapy. More than 4 weeks since surgery. | This study is being done to find how well PXD101 works in treating patients with relapsed or refractory aggressive B-cell non-Hodgkin's lymphoma. | II |
| Melanoma | ||||
| Metastatic or Unresectable | ECOG E2603 | ≥ 18 years old. Measurable disease. No brain metastases. No ocular melanoma. ≥ 4 weeks since biological therapy or radiation therapy. | This study is being done to find how well carboplatin, paclitaxel, and sorafenib work compared to carboplatin and paclitaxel in treating patients with unresected stage III or stage IV melanoma. | III |
| Myeloma | ||||
| Relapsed, Previously treated | SWOG S0434 | ≥ 18 years old. Measurable disease. Had received previous bortezomib therapy. More than 6 weeks since autologous stem cell transplant. At least 2-3 weeks since chemotherapy. At least 2 weeks since radiation therapy. No previous sorafenib. | This study is being done to find how well sorafenib works in treating patients with relapsed or refractory multiple myeloma. | II |
| Sarcoma | ||||