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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00041080
Recruitment Status : Completed
First Posted : January 27, 2003
Results First Posted : September 16, 2013
Last Update Posted : July 30, 2019
Sponsor:
Collaborator:
Gynecologic Oncology Group
Information provided by (Responsible Party):
National Cancer Institute (NCI)

Study Description
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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.

Condition or disease Intervention/treatment Phase
Fallopian Tube Cancer Primary Peritoneal Cavity Cancer Recurrent Ovarian Epithelial Cancer Stage III Ovarian Epithelial Cancer Stage IV Ovarian Epithelial Cancer Drug: tamoxifen citrate Drug: thalidomide Other: laboratory biomarker analysis Phase 3

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 139 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : February 2003
Actual Primary Completion Date : January 2011
Actual Study Completion Date : January 2011

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Arm I (thalidomide)
Patients receive oral thalidomide once daily on days 1-28.
 Drug: thalidomide
Given orally
Other Names:
  • Kevadon
  • Synovir
  • THAL
  • Thalomid

Other: laboratory biomarker analysis
Correlative studies
Experimental: Arm II (tamoxifen)
Patients receive oral tamoxifen twice daily on days 1-28.
 Drug: tamoxifen citrate
Given orally
Other Names:
  • Nolvadex
  • TAM
  • tamoxifen
  • TMX

Other: laboratory biomarker analysis
Correlative studies


Outcome Measures
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Primary Outcome Measures :
  1. Median Progression-free Survival [ Time Frame: from enrollment onto the study until first disease progression or death due to any cause ]

Eligibility Criteria
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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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)
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00041080


Locations
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United States, Pennsylvania
Gynecologic Oncology Group
Philadelphia, Pennsylvania, United States, 19103
Sponsors and Collaborators
National Cancer Institute (NCI)
Gynecologic Oncology Group
Investigators
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Principal Investigator: Jean Hurteau Gynecologic Oncology Group
More Information
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Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00041080    
Other Study ID Numbers: NCI-2012-02475
NCI-2012-02475 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
CDR0000069441
GOG-0198 ( Other Identifier: Gynecologic Oncology Group )
GOG-0198 ( Other Identifier: CTEP )
U10CA027469 ( U.S. NIH Grant/Contract )
First Posted: January 27, 2003    Key Record Dates
Results First Posted: September 16, 2013
Last Update Posted: July 30, 2019
Last Verified: July 2019
Additional relevant MeSH terms:
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Fallopian Tube Neoplasms
Carcinoma, Ovarian Epithelial
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Fallopian Tube Diseases
Adnexal Diseases
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Ovarian Neoplasms
Endocrine Gland Neoplasms
Ovarian Diseases
Endocrine System Diseases
 Gonadal Disorders
Tamoxifen
Thalidomide
Estrogen Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Selective Estrogen Receptor Modulators
Estrogen Receptor Modulators
Bone Density Conservation Agents
Immunosuppressive Agents
Immunologic Factors
Leprostatic Agents