Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outcomes
Outline
Trial Contact Information
Registry Information

Alternate Title

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

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase III	Treatment	Closed	Not specified	NCI	GOG-0198 NCT00041080

Special Category: CTSU trial

Objectives

1. 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.
2. Compare the toxic effects and complications associated with these drugs in these patients.
3. 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.
4. 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.

Entry Criteria

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

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)

Patient Characteristics:

Age:

• Not specified

Performance status:

• GOG 0-1

Life expectancy:

• Not specified

Hematopoietic:

• Absolute neutrophil count at least 1,500/mm³
• Platelet count at least 100,000/mm³

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

Expected Enrollment

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

Outcomes

Recurrence-free survival
Toxic effects and complications
Correlation of biomarker levels with drug treatment
Correlation of biomarker levels with duration of recurrence-free survival

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.

Trial Contact Information

Trial Lead Organizations

Gynecologic Oncology Group

Jean Hurteau, MD, Protocol chair		Ph: 847-570-2639; 888-909-5222

Registry Information
Official Title		A Randomized Study Of Tamoxifen Versus Thalidomide (NSC# 66847) In Patients With Biochemical-Recurrence-Only Epithelial Ovarian Cancer, Cancer Of The Fallopian Tube, And Primary Peritoneal Carcinoma After First Line Chemotherapy
Trial Start Date		2003-02-03
Registered in ClinicalTrials.gov		NCT00041080
Date Submitted to PDQ		2002-05-10
Information Last Verified		2008-01-16
NCI Grant/Contract Number		CA27469

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