Clinical trial NCT00041080: 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
Overall status: COMPLETED
Phase: PHASE3
Conditions: Fallopian Tube Cancer
Primary Peritoneal Cavity Cancer
Recurrent Ovarian Epithelial Cancer
Stage III Ovarian Epithelial Cancer
Stage IV Ovarian Epithelial Cancer
Lead sponsor: National Cancer Institute (NCI)
Sponsor class: NIH
Collaborators: name: Gynecologic Oncology Group
First posted: 2003-01-27
Enrollment: 139
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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)

Primary outcomes:
measure: Median Progression-free Survival
timeFrame: from enrollment onto the study until first disease progression or death due to any cause
Secondary outcomes:
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Gynecologic Oncology Group
state: Pennsylvania
Study officials:
affiliation: Gynecologic Oncology Group
name: Jean Hurteau
role: PRINCIPAL_INVESTIGATOR
References: