Tamoxifen Compared With Thalidomide in Treating Women With Ovarian Epithelial Cancer, Fallopian Tube Cancer, or Primary Peritoneal Cancer

Completed · Phase 3

Conditions studied: Fallopian Tube Cancer, Primary Peritoneal Cavity Cancer, Recurrent Ovarian Epithelial Cancer, Stage III Ovarian Epithelial Cancer, Stage IV Ovarian Epithelial Cancer

In brief

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.

Key facts

Study ID

NCT00041080

Run by

National Cancer Institute (NCI)

People needed

139

Starts

2003-02-01

Expected to finish

2011-01-01

Last updated by the study team

2019-07-30

Who can join

Age: any. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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

Where it is running

• Gynecologic Oncology Group — Philadelphia, Pennsylvania, United States

Full record on ClinicalTrials.gov

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