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Tamoxifen Compared With Thalidomide in Treating Women With Ovarian Epithelial Cancer, Fallopian Tube Cancer, or Primary Peritoneal Cancer
This study is ongoing, but not recruiting participants.
First Received: July 8, 2002   Last Updated: July 23, 2008   History of Changes
Sponsors and Collaborators: Gynecologic Oncology Group
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00041080
  Purpose

RATIONALE: 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.

PURPOSE: 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.


Condition Intervention Phase
Fallopian Tube Cancer
Ovarian Cancer
Peritoneal Cavity Cancer
Drug: tamoxifen citrate
Drug: thalidomide
Phase III

MedlinePlus related topics: Cancer Ovarian Cancer
Drug Information available for: Thalidomide Tamoxifen Tamoxifen citrate
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Active Control
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

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Recurrence-free survival [ Designated as safety issue: No ]
  • Toxic effects and complications [ Designated as safety issue: Yes ]
  • Correlation of biomarker levels with drug treatment [ Designated as safety issue: No ]
  • Correlation of biomarker levels with duration of recurrence-free survival [ Designated as safety issue: No ]

Estimated Enrollment: 260
Study Start Date: February 2003
Arms Assigned Interventions
Arm I: Experimental
Patients receive oral thalidomide once daily on days 1-28. Courses repeat every 28 days for up to 1 year in the absence of disease progression or unacceptable toxicity.
Drug: thalidomide
Given orally
Arm II: Active Comparator
Patients receive oral tamoxifen twice daily on days 1-28. Courses repeat every 28 days for up to 1 year in the absence of disease progression or unacceptable toxicity.
Drug: tamoxifen citrate
Given orally

Detailed Description:

OBJECTIVES:

  • Compare the recurrence-free survival of patients with only a biochemical recurrence of ovarian epithelial, fallopian tube, or primary peritoneal cancer after first-line chemotherapy treated with tamoxifen vs thalidomide.
  • Compare the toxic effects and complications associated with these drugs in these patients.
  • Determine whether changes in biomarker levels including, serum vascular endothelial growth factor (VEGF) and/or basic fibroblast growth factor (bFGF) in these patients are independent of the randomized drug treatment.
  • Determine whether biomarker levels including, serum and plasma VEGF and/or bFGF are associated with the duration of recurrence-free survival in patients treated with these drugs.

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.

PROJECTED ACCRUAL: A total of 260 patients will be accrued for this study within 6.5 years.

  Eligibility

Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • 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

PATIENT CHARACTERISTICS:

Age:

  • Not specified

Performance status:

  • GOG 0-1

Life expectancy:

  • Not specified

Hematopoietic:

  • Absolute neutrophil count at least 1,500/mm^3
  • Platelet count at least 100,000/mm^3

Hepatic:

  • 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

Renal:

  • Creatinine no greater than 1.5 times ULN OR
  • Creatinine clearance at least 60 mL/min

Cardiovascular:

  • No history of deep venous thrombosis
  • No prior cerebrovascular accident

Pulmonary:

  • No history of pulmonary embolism

Other:

  • 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

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • No prior immunotherapy (e.g., interleukins)
  • No prior biological response modifiers (e.g., monoclonal antibodies)
  • No prior antiangiogenic agents (e.g., carbonic anhydrase inhibitors)

Chemotherapy:

  • See Disease Characteristics
  • At least 3 weeks since prior anticancer chemotherapy and recovered

Endocrine therapy:

  • 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)

Radiotherapy:

  • At least 3 weeks since prior anticancer radiotherapy and recovered

Surgery:

  • At least 3 weeks since prior anticancer surgery and recovered
  • Prior second-look surgery without cytoreduction allowed

Other:

  • 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00041080

Locations
United States, Illinois
Carle Cancer Center at Carle Foundation Hospital
Urbana, Illinois, United States, 61801
CCOP - Carle Cancer Center
Urbana, Illinois, United States, 61801
Joliet Oncology-Hematology Associates, Limited - West
Joliet, Illinois, United States, 60435
United States, Indiana
Saint Anthony Memorial Health Centers
Michigan City, Indiana, United States, 46360
United States, Kentucky
James Graham Brown Cancer Center at University of Louisville
Louisville, Kentucky, United States, 40202
United States, Louisiana
Christus Schumpert Cancer Treatment Center
Shreveport, Louisiana, United States, 71101
United States, Michigan
William Beaumont Hospital - Royal Oak Campus
Royal Oak, Michigan, United States, 48073
United States, New Jersey
Jersey Shore Cancer Center at Jersey Shore University Medical Center
Neptune, New Jersey, United States, 07754-0397
Sponsors and Collaborators
Gynecologic Oncology Group
Investigators
Study Chair: Jean A. Hurteau, MD Evanston Northwestern Healthcare - Evanston Hospital
  More Information

Additional Information:
No publications provided

Study ID Numbers: CDR0000069441, GOG-0198
Study First Received: July 8, 2002
Last Updated: July 23, 2008
ClinicalTrials.gov Identifier: NCT00041080     History of Changes
Health Authority: United States: Food and Drug Administration

Keywords provided by National Cancer Institute (NCI):
stage III ovarian epithelial cancer
stage IV ovarian epithelial cancer
recurrent ovarian epithelial cancer
fallopian tube cancer
peritoneal cavity cancer

Study placed in the following topic categories:
Fallopian Tube Cancer
Immunologic Factors
Thalidomide
Gonadal Disorders
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Bone Density Conservation Agents
Urogenital Neoplasms
Ovarian Diseases
Selective Estrogen Receptor Modulators
Hormones
Genital Diseases, Female
Anti-Bacterial Agents
Estrogen Receptor Modulators
Peritoneal Diseases
Ovarian Cancer
Endocrine Gland Neoplasms
Estrogen Antagonists
Estrogens
Ovarian Neoplasms
Digestive System Neoplasms
Antineoplastic Agents, Hormonal
Citric Acid
Genital Neoplasms, Female
Endocrine System Diseases
Abdominal Neoplasms
Ovarian Epithelial Cancer
Angiogenesis Inhibitors
Immunosuppressive Agents
Tamoxifen

Additional relevant MeSH terms:
Anti-Infective Agents
Immunologic Factors
Thalidomide
Gonadal Disorders
Antineoplastic Agents
Hormone Antagonists
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Bone Density Conservation Agents
Urogenital Neoplasms
Ovarian Diseases
Selective Estrogen Receptor Modulators
Genital Diseases, Female
Anti-Bacterial Agents
Estrogen Receptor Modulators
Neoplasms by Site
Therapeutic Uses
Peritoneal Diseases
Growth Inhibitors
Angiogenesis Modulating Agents
Endocrine Gland Neoplasms
Estrogen Antagonists
Ovarian Neoplasms
Digestive System Neoplasms
Antineoplastic Agents, Hormonal
Growth Substances
Genital Neoplasms, Female
Endocrine System Diseases
Abdominal Neoplasms
Angiogenesis Inhibitors

ClinicalTrials.gov processed this record on May 07, 2009