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| Overall Recruitment Status: Enrollment complete |
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| Official Title |
| A Phase III Trial of Every-3-Weeks Paclitaxel Versus Dose Dense Weekly Paclitaxel in Combination With Carboplatin With or Without Concurrent and Consolidation Bevacizumab (NSC #704865) in the Treatment of Primary Stage II, III or IV Epithelial Ovarian, Peritoneal or Fallopian Tube Cancer and ACRIN 6695: Perfusion CT Imaging to Evaluate Treatment Response in Patients Participating in GOG-0262 |
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| Region |
Sponsors |
| California - Northern |
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| Acronym |
NCT No. |
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NCT01167712 |
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| Study Type |
Phase |
| INTERVENTIONAL |
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| Purpose |
| This phase III clinical trial studies two different dose schedules of paclitaxel to see how well they work in combination with carboplatin with or without bevacizumab in treating patients with stage II, III or IV ovarian epithelial cancer, primary peritoneal cancer, or fallopian tube cancer. Drugs used in chemotherapy, such as paclitaxel and carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Bevacizumab is a type of drug called a monoclonal antibody and blocks tumor growth by stopping the growth of blood vessels that tumors need to grow. It is not yet known whether giving paclitaxel with combination chemotherapy once every three weeks is more effective than giving paclitaxel once a week in treating patients with ovarian, primary peritoneal, or fallopian tube cancer. |
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| Detailed Description |
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- Primary Surgery and Neoadjuvant Chemotherapy with Interval Cytoreductive Surgery Patients.
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Patients must have measurable disease. At least one target lesion must have a minimum length of 1 cm in both the long and short axis (determined at the local site). For primary surgery patients, if no radiographic evidence of measurable disease is obtained prior to registration this can be based on surgical findings. Imaging then would need to be completed in the 14 days between Gynecology Oncology Group (GOG) registration and chemotherapy initiation
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Neoadjuvant Chemotherapy (NAC) with Interval Cytoreductive Surgery (ICS) Patients
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For patients undergoing NAC-ICS, a core tissue (not fine needle aspiration) biopsy is required. The tissue must be consistent with a Müllerian origin
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- patients will require documentation of at least stage II or extraovarian sites of disease acquired via imaging or surgery (without attempt at cytoreduction)
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Patients with the following histologic epithelial cell types are eligible: serous, endometrioid, clear cell, mucinous adenocarcinoma, undifferentiated carcinoma, mixed epithelial carcinoma, transitional cell carcinoma, malignant Brenner's Tumor, or adenocarcinoma not otherwise specified (N.O.S.). However, the histologic features of the tumor must be compatible with a primary Müllerian epithelial adenocarcinoma. Patients may have co-existing fallopian tube carcinoma in-situ so long as the primary origin of invasive tumor is ovarian, peritoneal or fallopian tube of note, patients with clear cell and mucinous tumors will be eligible unless there is a higher priority protocol
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Please contact study personnel for more eligibility criteria
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- Patients who have received prior radiotherapy to any portion of the abdominal cavity or pelvis. Prior radiation for localized cancer of the breast, head and neck, or skin is permitted, provided that it was completed more than three years prior to registration, and the patient remains free of recurrent or metastatic disease
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Patients who have received prior chemotherapy for any abdominal or pelvic tumor including neo-adjuvant chemotherapy for their ovarian, primary peritoneal or fallopian tube cancer. Patients may have received prior adjuvant chemotherapy for localized breast cancer, provided that it was completed more than three years prior to registration, and that the patient remains free of recurrent or metastatic disease
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Patients who have received any targeted therapy (including but not limited to vaccines, antibodies, tyrosine kinase inhibitors) or hormonal therapy for management of their epithelial ovarian, fallopian tube or peritoneal primary cancer
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Patients with synchronous primary endometrial cancer, or a past history of primary endometrial cancer, unless all of the following conditions are met: stage not greater than I-A, grade 1 or 2, no more than superficial myometrial invasion, without vascular or lymphatic invasion. No poorly differentiated subtypes, including papillary serous, clear cell or other FIGO grade 3 lesions
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With the exception of non-melanoma skin cancer, patients with other invasive malignancies who had (or have) any evidence of the other cancer present within the last five years or whose previous cancer treatment contraindicates this protocol therapy
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Patients with acute hepatitis or active infection that requires parenteral antibiotics
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Fallopian Tube Adenocarcinoma
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Neoplasms by Histologic Type
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- Undifferentiated Ovarian Carcinoma
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Neoplasms, Glandular and Epithelial
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Primary Peritoneal Serous Adenocarcinoma
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Carcinoma, Ovarian Epithelial
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Carcinoma, Transitional Cell
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Cystadenocarcinoma, Serous
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