Thalidomide in Treating Patients With Refractory or Resistant Epithelial Ovarian Cancer

NCT00016224 | Completed Phase 2

• 3 other identifiers: 01-006CDR0000068611NCI-G01-1943
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

RATIONALE: Drugs such as thalidomide may stop the growth of cancer cells by stopping blood flow to the tumor. PURPOSE: Phase II trial to study the effectiveness of thalidomide in treating women who have epithelial ovarian cancer that has not responded to previous therapy.

Conditions

Ovarian Cancer

Keywords

recurrent ovarian epithelial cancer

Interventions

thalidomide DRUG

Eligibility Criteria

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

DISEASE CHARACTERISTICS: * Histologically confirmed ovarian epithelial carcinoma * Platinum-refractory or resistant disease * At least 1 prior non-platinum chemotherapy agent required * Prior bilateral salpingo-oophorectomy and hysterectomy required * Bidimensionally measurable disease OR CA-125 greater than 100 units/mm3 PATIENT CHARACTERISTICS: Age: * Over 18 Performance status: * Karnofsky 70-100% Life expectancy: * More than 3 months Hematopoietic: * Not specified Hepatic: * Bilirubin normal * AST no greater than 2.5 times upper limit of normal (ULN) Renal: * Creatinine no greater than 1.5 times ULN OR * Creatinine clearance at least 50 mL/min Other: * No other prior malignancy except non-melanoma skin cancer unless curatively treated with no evidence of disease within the past 5 years and at low risk for recurrence * No other clinical circumstances that would preclude study PRIOR CONCURRENT THERAPY: Biologic therapy: * At least 4 weeks since prior biologic therapy and recovered * No prior thalidomide Chemotherapy: * See Disease Characteristics * At least 4 weeks since prior cytotoxic therapy and recovered Endocrine therapy: * At least 4 weeks since prior hormonal therapy and recovered Radiotherapy: * At least 4 weeks since prior radiotherapy Surgery: * See Disease Characteristics * At least 4 weeks since prior major surgery

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Memorial Sloan Kettering Cancer Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Memorial Sloan-Kettering Cancer Center

New York, New York, 10021, United States

Location

MeSH Terms

Conditions

Ovarian Neoplasms; Carcinoma, Ovarian Epithelial

Interventions

Thalidomide

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Phthalimides; Phthalic Acids; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Piperidones; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Isoindoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• David R. Spriggs, MD

  Memorial Sloan Kettering Cancer Center

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Purpose: TREATMENT
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: May 6, 2001
• First Posted: January 27, 2003
• Study Start: January 1, 2001
• Primary Completion: March 1, 2004
• Study Completion: March 1, 2004
• Last Updated: June 18, 2013

Record last verified: 2013-06

Locations

US (1)