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

Primary Purpose

Fallopian Tube Cancer, Primary Peritoneal Cavity Cancer, Recurrent Ovarian Epithelial Cancer

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
tamoxifen citrate
thalidomide
laboratory biomarker analysis
Sponsored by
National Cancer Institute (NCI)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Fallopian Tube Cancer

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)FemaleDoes not accept healthy volunteers

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)

Sites / Locations

  • Gynecologic Oncology Group

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Arm I (thalidomide)

Arm II (tamoxifen)

Arm Description

Patients receive oral thalidomide once daily on days 1-28.

Patients receive oral tamoxifen twice daily on days 1-28.

Outcomes

Primary Outcome Measures

Median Progression-free Survival

Secondary Outcome Measures

Full Information

First Posted
July 8, 2002
Last Updated
July 22, 2019
Sponsor
National Cancer Institute (NCI)
Collaborators
Gynecologic Oncology Group
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1. Study Identification

Unique Protocol Identification Number
NCT00041080
Brief Title
Tamoxifen Compared With Thalidomide in Treating Women With Ovarian Epithelial Cancer, Fallopian Tube Cancer, or Primary Peritoneal Cancer
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 Type
Interventional

2. Study Status

Record Verification Date
July 2019
Overall Recruitment Status
Completed
Study Start Date
February 2003 (undefined)
Primary Completion Date
January 2011 (Actual)
Study Completion Date
January 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Cancer Institute (NCI)
Collaborators
Gynecologic Oncology Group

4. Oversight

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fallopian Tube Cancer, Primary Peritoneal Cavity Cancer, Recurrent Ovarian Epithelial Cancer, Stage III Ovarian Epithelial Cancer, Stage IV Ovarian Epithelial Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
139 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Arm I (thalidomide)
Arm Type
Experimental
Arm Description
Patients receive oral thalidomide once daily on days 1-28.
Arm Title
Arm II (tamoxifen)
Arm Type
Experimental
Arm Description
Patients receive oral tamoxifen twice daily on days 1-28.
Intervention Type
Drug
Intervention Name(s)
tamoxifen citrate
Other Intervention Name(s)
Nolvadex, TAM, tamoxifen, TMX
Intervention Description
Given orally
Intervention Type
Drug
Intervention Name(s)
thalidomide
Other Intervention Name(s)
Kevadon, Synovir, THAL, Thalomid
Intervention Description
Given orally
Intervention Type
Other
Intervention Name(s)
laboratory biomarker analysis
Intervention Description
Correlative studies
Primary Outcome Measure Information:
Title
Median Progression-free Survival
Time Frame
from enrollment onto the study until first disease progression or death due to any cause

10. Eligibility

Sex
Female
Accepts Healthy Volunteers
No
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jean Hurteau
Organizational Affiliation
Gynecologic Oncology Group
Official's Role
Principal Investigator
Facility Information:
Facility Name
Gynecologic Oncology Group
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19103
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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