Combination Chemotherapy in Treating Patients With Platinum-Resistant Recurrent Ovarian Cancer

NCT00003449 | Completed Phase 2 DMC

• 3 other identifiers: CDR0000066478 (5O-98-1)LAC-USC-5O981NCI-G98-1460
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

Brief Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. PURPOSE: Phase II trial to study the effectiveness of dexamethasone plus paclitaxel and gemcitabine in treating patients with platinum-resistant recurrent ovarian cancer.

Conditions

Ovarian Cancer

Keywords

recurrent ovarian epithelial cancer

Interventions

dexamethasone DRUG

gemcitabine hydrochloride DRUG

paclitaxel DRUG

Eligibility Criteria

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

DISEASE CHARACTERISTICS: * Histologically confirmed recurrent ovarian epithelial cancer * Platinum resistant disease defined as: * Progression during the most recent platinum-based chemotherapy OR * Relapse less than 6 months after platinum-based chemotherapy * Measurable or evaluable disease * Elevated CA-125 only allowed * Positive cytology only not eligible PATIENT CHARACTERISTICS: Age: * 18 and over Performance status: * SWOG 0-2 Hematopoietic: * Granulocyte count at least 1,500/mm\^3 * Platelet count at least 100,000/mm\^3 Hepatic: * Bilirubin less than 2 times upper limit of normal (ULN) * AST less than 3 times ULN Renal: * Creatinine no greater than 2 mg/dL Neurologic: * No peripheral neuropathy greater than grade 2 Other: * No other serious medical illness or psychiatric conditions. PRIOR CONCURRENT THERAPY: Biologic therapy: * No concurrent hematopoietic growth factors Chemotherapy: * See Disease Characteristics * No prior gemcitabine * No prior paclitaxel administered weekly Endocrine therapy: * Not specified Radiotherapy: * Not specified Surgery: * Not specified Other: * Recovered from acute toxic effects secondary to prior therapy

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

Sponsors & Collaborators

• University of Southern California: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

USC/Norris Comprehensive Cancer Center and Hospital

Los Angeles, California, 90033-0804, United States

Location

MeSH Terms

Conditions

Ovarian Neoplasms; Carcinoma, Ovarian Epithelial

Interventions

Dexamethasone; Gemcitabine; Paclitaxel

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)

Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated; Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes

Study Officials

• Agustin Garcia, MD

  University of Southern California

  STUDY CHAIR

Study Design

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

Study Record Dates

• First Submitted: November 1, 1999
• First Posted: September 24, 2003
• Study Start: May 1, 1998
• Primary Completion: June 1, 2002
• Study Completion: February 1, 2004
• Last Updated: May 22, 2014

Record last verified: 2014-05

Locations

US (1)