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

NCT00041080 | Completed Phase 3 Results

• 4 other identifiers: NCI-2012-02475CDR0000069441GOG-0198U10CA027469
• Study Type: interventional
• Target: 139
• Locations: 1 country
• Sites: 1

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.

Conditions

Fallopian Tube Cancer; Primary Peritoneal Cavity Cancer; Recurrent Ovarian Epithelial Cancer; Stage III Ovarian Epithelial Cancer; Stage IV Ovarian Epithelial Cancer

Outcome Measures

Primary Outcomes (1)

• Median Progression-free Survival

  from enrollment onto the study until first disease progression or death due to any cause

Study Arms (2)

Arm I (thalidomide)

EXPERIMENTAL

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

Drug: thalidomide; Other: laboratory biomarker analysis

Arm II (tamoxifen)

EXPERIMENTAL

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

Drug: tamoxifen citrate; Other: laboratory biomarker analysis

Interventions

tamoxifen citrate DRUG

Given orally

Also known as: Nolvadex, TAM, tamoxifen, TMX

Arm II (tamoxifen)

thalidomide DRUG

Given orally

Also known as: Kevadon, Synovir, THAL, Thalomid

Arm I (thalidomide)

laboratory biomarker analysis OTHER

Correlative studies

Arm I (thalidomide); Arm II (tamoxifen)

Eligibility Criteria

• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

Sponsors & Collaborators

• National Cancer Institute (NCI): lead
• Gynecologic Oncology Group: collaborator

Study Sites (1)

Gynecologic Oncology Group

Philadelphia, Pennsylvania, 19103, United States

Location

MeSH Terms

Conditions

Fallopian Tube Neoplasms; Carcinoma, Ovarian Epithelial

Interventions

Tamoxifen; Thalidomide

Condition Hierarchy (Ancestors)

Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Fallopian Tube Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Ovarian Neoplasms; Endocrine Gland Neoplasms; Ovarian Diseases; Endocrine System Diseases; Gonadal Disorders

Intervention Hierarchy (Ancestors)

Stilbenes; Benzylidene Compounds; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Phthalimides; Phthalic Acids; Acids, Carbocyclic; Carboxylic Acids; Piperidones; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Isoindoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Results Point of Contact

• Title: Melissa Leventhal
• Organization: Gynecologic Oncology Group (GOG) Statistical and Data Center

mleventhal@gogstats.org

716-845-4030

Study Officials

• Jean Hurteau

  Gynecologic Oncology Group

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 8, 2002
• First Posted: January 27, 2003
• Study Start: February 1, 2003
• Primary Completion: January 1, 2011
• Study Completion: January 1, 2011
• Last Updated: July 30, 2019
• Results First Posted: September 16, 2013

Record last verified: 2019-07

Locations

US (1)