GOG 212: A Randomized Phase III Trial of maintenance chemotherapy comparing 12, monthly cycles of single agent Paclitaxel or Xyotax (CT-2103) (IND# 70177), versus no treatment until documented relapse in women with advanced Ovarian or primary Peritonel cancer who achieve a complete clinical response to primary Platinum/Taxane Chemotherapy
The patients will undergo a thorough check-up prior to the start of treatment. This will consist of: physical examination which may include pelvic examination; blood counts, eKG (a test to check your heart function), pregnancy test (if applicable), urine test, check-up of liver and kidney status through blood studies. Detectable tumor will be measured by pelvic examination, CT scan, or other methods. Blood counts will be repeated every week throughout most of your treatment. Liver and kidney function will be checked prior to each treatment cycle. other tests will be repeated, if necessary. Results from these check-ups will be submitted to the GoG for analysis as a part of the study.
The patients will be asked to complete a questionnaire about the quality of their life. Patients will be asked to complete the questionnaire a total of six times, once before patients go on study, 2, 4, 6 and 12 months later, and then one year after patients have completed their treatment (or observation if the patients do not received treatment). There are 37 questions and it will take about 5-10 minutes to complete each time.
Chemotherapy Procedures: The treatment that the patients receive will be determined by a process known as randomization, which is similar to the flipping of a coin. neither the patients nor their doctor will know which treatment the patients will receive, or whether the patients will receive no further chemotherapy unless the patients show signs of relapse, until you are entered on the study.
if the patients are randomized to the no treatment arm of the study, you will be followed by the doctor for signs of disease progression. if the patient's disease progresses, the patient will be removed from the study and counseled on appropriate treatment at that time.
if the patients are randomized to receive either paclitaxel or CT-2103, the patients will be given the drug, once a month through their vein, for a maximum of 12 monthly cycles. The paclitaxel is delivered over 3 hours, while CT-2103 is given as a 10-20 minute infusion.
The patient will undergo the following procedures that are not part of regular cancer care and are being done on because the patient is in this study.
* The patient will be asked to provide samples of their tumor (if available from a previous surgery) and blood for laboratory testing that is not part of regular cancer care and is being done only because the patient is in this study. The patient can still participate in this study if the patient does not give permission for their specimens to be collected and used for this optional research.
Blood and Tumor Collection for Laboratory Testing: in addition to being treated for their cancer, the patients will be asked to participate in laboratory studies. This means that the patients will provide 6 teaspoons of blood sample during the study. The first 2 teaspoons of blood sample will be drawn into 1 tube before starting your first cycle of chemotherapy and used to prepare serum for laboratory testing. The second 2 teaspoons of blood sample will be drawn into 1 tube before starting their second cycle of treatment and used to prepare serum for laboratory testing. Before, during or after treatment, 2 teaspoons of blood will be drawn into 1 tube.
Serum is the liquid part of blood after the blood is allowed to clot and both the clot and the blood cells are removed. if the patients are being treated at an institution outside of the united States, the patients will not be asked to provide these blood samples. additionally, a sample of their ovarian tumor will need to be submitted for laboratory testing.
1.Patients with a histologic diagnosis of primary peritoneal carcinoma or epithelial ovarian carcinoma, Stage III or IV, with either optimal (<= 1 cm residual disease) or suboptimal residual disease following initial surgery. All patients must have had appropriate surgery for ovarian, primary peritoneal or fallopian tube carcinoma with appropriate tissue available for histologic evaluation to confirm diagnosis and stage.
2.Patients with the following histologic epithelial cell types are eligible: Serous adenocarcinoma, endometrioid adenocarcinoma, mucinous adenocarcinoma, undifferentiated carcinoma, clear cell adenocarcinoma, mixed epithelial carcinoma, transitional cell carcinoma, malignant Brenner's Tumor, or adenocarcinoma N.O.S.
3.Patients must have completed treatment within the past 12 weeks with at least 5 cycles and not more than 8 cycles of platinum (IV or IP) and paclitaxel or docetaxel-based combination chemotherapy and have no symptoms suggestive of persistent cancer, normal CT scan of the abdomen/pelvis and normal (no evidence of cancer) CA-125 following this therapy.
3a. Patients treated with neo-adjuvant platinum-taxane chemotherapy for a presumptive diagnosis of stage III or IV primary peritoneal carcinoma or epithelial ovarian carcinoma (by paracentesis, percutaneous biopsy or open biopsy) are eligible provided that they have undergone interval abdominal surgery after at least one but no more than six cycles of standard chemotherapy as defined in section 3.13. Such surgery must meet the same criteria as for those undergoing up front surgery, including tissue diagnosis for confirmation of primary tumor site and Stage III or IV disease. Also, patients must have received at least two cycles after interval abdominal surgery.
4.Patients must have adequate: Bone marrow function: Absolute neutrophil count (ANC) greater than or equal to 1,500/ul, equivalent to Common Toxicity Criteria (CTC) grade 1. Platelets greater than or equal to 100,000/ul. Renal function: creatinine less than or equal to 1.5 x institutional upper limit normal (ULN), CTC grade 1. Hepatic function: Bilirubin less than or equal to 1.5 x ULN (CTC grade 1). SGOT and alkaline phosphatase less than or equal to 2.5 x ULN (CTC grade 1). Neurologic function: Neuropathy (sensory and motor) less than or equal to CTC grade 1.
5.Patients must have a GOG Performance Status of 0, 1, or 2.
6.Patients must have signed an approved informed consent and HIPAA authorization.
7.Patients must complete pre-entry assessments as outlined in section 7.0 of the protocol.
8.English and Spanish speaking patients are eligible to participate in this study.
9.Patients who are pregnant or nursing are excluded; patients who may become pregnant must practice an effective method of birth control.