NCT00003385

Combination Chemotherapy in Treating Patients With Untreated Ovarian, Peritoneal, or Fallopian Tube Cancer

A Phase I Study of Paclitaxel, Carboplatin, and Increasing Doses of Doxil in Untreated Ovarian, Peritoneal, and Tubal Carcinoma

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 48 (estimated)
• Sponsor: Gynecologic Oncology Group · Network
• Sex: Female
• Age: —
• Healthy volunteers: Not accepted

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 I trial to study the effectiveness of combination chemotherapy consisting of liposomal doxorubicin, paclitaxel, and carboplatin in treating patients who have untreated ovarian, peritoneal, or fallopian tube cancer.

Detailed description

OBJECTIVES: * Determine the maximum tolerated dose of doxorubicin HCl liposome when administered with paclitaxel and carboplatin in patients with previously untreated ovarian epithelial, peritoneal, or fallopian tube cancer. * Determine the toxicity of this treatment regimen in these patients. * Evaluate measurable disease in patients treated with this regimen. OUTLINE: This is a dose-escalation study of doxorubicin HCl liposome (LipoDox). Patients receive LipoDox IV on day 1, carboplatin IV over 3 hours on days 1 and 22, and paclitaxel IV over 1 hour on days 1, 8, 15, 22, 29, and 36. Treatment repeats every 42 days for 4 courses in the absence of unacceptable toxicity or disease progression. Cohorts of 3-6 patients receive escalating doses of LipoDox until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. An additional cohort of 12 patients receives LipoDox at the MTD with carboplatin and paclitaxel as above. Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter. PROJECTED ACCRUAL: Approximately 48 patients will be accrued for this study within 2 years.

Conditions

• Fallopian Tube Cancer
• Ovarian Cancer
• Primary Peritoneal Cavity Cancer

Interventions

Type	Name	Description
DRUG	carboplatin
DRUG	paclitaxel
DRUG	pegylated liposomal doxorubicin hydrochloride

Timeline

• Start date: 1999-03-01
• Primary completion: 2007-01-01
• First posted: 2003-01-27
• Last updated: 2013-05-27

Locations

8 sites across 2 countries: United States, Norway