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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


Phase 3
N/A
N/A
Not Enrolling
Female
Fallopian Tube Cancer, Primary Peritoneal Cavity Cancer, Recurrent Ovarian Epithelial Cancer, Stage III Ovarian Epithelial Cancer, Stage IV Ovarian Epithelial Cancer

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Trial Information

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


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.


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)

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Recurrence-free survival

Outcome Time Frame:

Up to 8 years

Safety Issue:

No

Principal Investigator

Jean Hurteau

Investigator Role:

Principal Investigator

Investigator Affiliation:

Gynecologic Oncology Group

Authority:

United States: Food and Drug Administration

Study ID:

NCI-2012-02475

NCT ID:

NCT00041080

Start Date:

February 2003

Completion Date:

Related Keywords:

  • Fallopian Tube Cancer
  • Primary Peritoneal Cavity Cancer
  • Recurrent Ovarian Epithelial Cancer
  • Stage III Ovarian Epithelial Cancer
  • Stage IV Ovarian Epithelial Cancer
  • Peritoneal Neoplasms
  • Fallopian Tube Neoplasms
  • Neoplasms, Glandular and Epithelial
  • Ovarian Neoplasms

Name

Location

Gynecologic Oncology GroupPhiladelphia, Pennsylvania  19103