Tamoxifen Compared With Thalidomide in Treating Women With Ovarian Epithelial Cancer, Fallopian Tube Cancer, or Primary Peritoneal Cancer
Condition: Fallopian Tube Cancer; Primary Peritoneal Cavity Cancer; Recurrent Ovarian Epithelial Cancer; Stage III Ovarian Epithelial Cancer; Stage IV Ovarian Epithelial Cancer
MeSH terms: Fallopian Tube Neoplasms; Carcinoma, Ovarian Epithelial
Intervention: tamoxifen citrate; thalidomide; laboratory biomarker analysis
Intervention description: Given orally; Given orally; Correlative studies
Intervention MeSH terms: Tamoxifen; Thalidomide
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 139.0
Sex: Female
Healthy volunteers: No

Summary:

      Randomized phase III trial to compare the effectiveness of tamoxifen with that of thalidomide
      in treating women who have recurrent ovarian epithelial cancer, fallopian tube cancer, or
      primary peritoneal cancer. Estrogen can stimulate the growth of some types of cancer cells.
      Hormone therapy using tamoxifen may fight cancer by blocking the uptake of estrogen.
      Thalidomide may stop the growth of cancer by stopping blood flow to the tumor. It is not yet
      known whether thalidomide is more effective than tamoxifen in treating ovarian epithelial
      cancer, fallopian tube cancer, or primary peritoneal 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)