• Recurrence-free survival [ Designated as safety issue: No ]
  
• Toxic effects and complications [ Designated as safety issue: Yes ]
  
• Correlation of biomarker levels with drug treatment [ Designated as safety issue: No ]
  
• Correlation of biomarker levels with duration of recurrence-free survival [ Designated as safety issue: No ]
  

OBJECTIVES:

• Compare the recurrence-free survival of patients with only a biochemical recurrence of ovarian epithelial, fallopian tube, or primary peritoneal cancer after first-line chemotherapy treated with tamoxifen vs thalidomide.
• Compare the toxic effects and complications associated with these drugs in these patients.
• Determine whether changes in biomarker levels including, serum vascular endothelial growth factor (VEGF) and/or basic fibroblast growth factor (bFGF) in these patients are independent of the randomized drug treatment.
• Determine whether biomarker levels including, serum and plasma VEGF and/or bFGF are associated with the duration of recurrence-free survival in patients treated with these drugs.

OUTLINE: This is a randomized, multicenter study. Patients are stratified according to the interval between completion of front-line chemotherapy and appearance of biochemical progression (6 months or less vs more than 6 months). Patients are randomized to 1 of 2 treatment arms.

• Arm I: Patients receive oral thalidomide once daily on days 1-28.
• Arm II: Patients receive oral tamoxifen twice daily on days 1-28. In both arms, courses repeat every 28 days for up to 1 year in the absence of disease progression or unacceptable toxicity. Patients may receive additional therapy beyond 1 year at the investigator's discretion.

Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter.

PROJECTED ACCRUAL: A total of 260 patients will be accrued for this study within 6.5 years.

DISEASE CHARACTERISTICS:

• 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

PATIENT CHARACTERISTICS:

Age:

• Not specified

Performance status:

• GOG 0-1

Life expectancy:

• Not specified

Hematopoietic:

• Absolute neutrophil count at least 1,500/mm^3
• Platelet count at least 100,000/mm^3

Hepatic:

• 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

Renal:

• Creatinine no greater than 1.5 times ULN OR
• Creatinine clearance at least 60 mL/min

Cardiovascular:

• No history of deep venous thrombosis
• No prior cerebrovascular accident

Pulmonary:

• No history of pulmonary embolism

Other:

• 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

PRIOR CONCURRENT THERAPY:

Biologic therapy:

• No prior immunotherapy (e.g., interleukins)
• No prior biological response modifiers (e.g., monoclonal antibodies)
• No prior antiangiogenic agents (e.g., carbonic anhydrase inhibitors)

Chemotherapy:

• See Disease Characteristics
• At least 3 weeks since prior anticancer chemotherapy and recovered

Endocrine therapy:

• 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)

Radiotherapy:

• At least 3 weeks since prior anticancer radiotherapy and recovered

Surgery:

• At least 3 weeks since prior anticancer surgery and recovered
• Prior second-look surgery without cytoreduction allowed

Other:

• 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)