DrugLib.com — Drug Information Portal

Rx drug information, pharmaceutical research, clinical trials, news, and more



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

Information source: National Cancer Institute (NCI)
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Fallopian Tube Cancer; Primary Peritoneal Cavity Cancer; Recurrent Ovarian Epithelial Cancer; Stage III Ovarian Epithelial Cancer; Stage IV Ovarian Epithelial Cancer

Intervention: tamoxifen citrate (Drug); thalidomide (Drug); laboratory biomarker analysis (Other)

Phase: Phase 3

Status: Completed

Sponsored by: National Cancer Institute (NCI)

Official(s) and/or principal investigator(s):
Jean Hurteau, Principal Investigator, Affiliation: Gynecologic Oncology Group

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.

Clinical Details

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

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Median Progression-free Survival

Detailed description: PRIMARY OBJECTIVES: I. To compare the recurrence-free survival of women receiving tamoxifen or thalidomide for epithelial ovarian cancer, cancer of the fallopian tube, or primary peritoneal carcinoma who are in complete clinical remission following front-line treatment but have a high risk of recurrence due to rising serum CA-125. II. To compare the toxicities and complications of these treatments. SECONDARY OBJECTIVES: I. To determine whether changes in serum biomarker levels including VEGF and/or bFGF are independent of the randomization treatment. II. To determine whether serum and plasma biomarker levels including VEGF and/or bFGF are associated with the 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.

Eligibility

Minimum age: N/A. Maximum age: N/A. Gender(s): Female.

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)

Locations and Contacts

Gynecologic Oncology Group, Philadelphia, Pennsylvania 19103, United States
Additional Information

Starting date: February 2003
Last updated: April 29, 2014

Page last updated: August 23, 2015

-- advertisement -- The American Red Cross
 
Home | About Us | Contact Us | Site usage policy | Privacy policy

All Rights reserved - Copyright DrugLib.com, 2006-2017