Tamoxifen Compared With Thalidomide in Treating Women With Ovarian Epithelial Cancer, Fallopian Tube Cancer, or Primary Peritoneal Cancer
Fallopian Tube Cancer, Primary Peritoneal Cavity Cancer, Recurrent Ovarian Epithelial Cancer
About this trial
This is an interventional treatment trial for Fallopian Tube Cancer
Eligibility Criteria
Inclusion Criteria: Histologically confirmed stage III or IV ovarian epithelial, fallopian tube, or primary peritoneal cancer that was treated with only 1 prior first-line chemotherapy regimen (platinum/taxane-based) Clinically and radiologically without evidence of measurable and nonmeasurable disease Symptomatic ascites and pleural effusions are considered nonmeasurable disease Must have a biochemical recurrence CA 125 must have been normal prior to or normalized during first-line therapy and then subsequently rose to exceed twice the upper limit of normal Patients entering study with a CA 125 level less than 100 U/mL must be confirmed a second time within a period of not more than 4 weeks Patients with a CA 125 level of at least 100 U/mL may be entered without confirmatory measurement Ineligible for a higher priority Gynecologic Oncology Group protocol (if one exists) No history of brain metastases Performance status - GOG 0-1 Absolute neutrophil count at least 1,500/mm^3 Platelet count at least 100,000/mm^3 Bilirubin no greater than 1.5 times upper limit of normal (ULN) SGOT no greater than 2.5 times ULN Alkaline phosphatase no greater than 2.5 times ULN Creatinine no greater than 1.5 times ULN Creatinine clearance at least 60 mL/min No history of deep venous thrombosis No prior cerebrovascular accident No history of pulmonary embolism No significant infection No grade 2 or greater sensory or motor neuropathy No other malignancy within the past 5 years except nonmelanoma skin cancer or carcinoma in situ Not pregnant or nursing Negative pregnancy test Fertile patients must use at least 1 highly active method and at least 1 additional effective method of contraception for 4 weeks before, during, and for 4 weeks after study participation No prior immunotherapy (e.g., interleukins) No prior biological response modifiers (e.g., monoclonal antibodies) No prior antiangiogenic agents (e.g., carbonic anhydrase inhibitors) At least 3 weeks since prior anticancer chemotherapy and recovered No prior or concurrent tamoxifen or other selective estrogen receptor modulators At least 4 weeks since prior and no concurrent hormones (e.g., estrogen or progesterone) At least 3 weeks since prior anticancer radiotherapy and recovered At least 3 weeks since prior anticancer surgery and recovered Prior second-look surgery without cytoreduction allowed At least 3 weeks since other prior anticancer therapy and recovered No prior interval cytoreduction No concurrent full-dose therapeutic anticoagulation No concurrent antiseizure medications for seizure disorder No concurrent bisphosphonates (e.g., zoledronate)
Sites / Locations
- Gynecologic Oncology Group
Arms of the Study
Arm 1
Arm 2
Experimental
Experimental
Arm I (thalidomide)
Arm II (tamoxifen)
Patients receive oral thalidomide once daily on days 1-28.
Patients receive oral tamoxifen twice daily on days 1-28.