NCT00003380

Liposomal Doxorubicin and Etoposide in Treating Patients With Recurrent or Persistent Ovarian, Fallopian Tube, or Peritoneal Cancer

A Phase I Study of Liposomal Doxorubicin (Doxil) and Prolonged Etoposide As Second Line Therapy in Ovarian, Tubal and Peritoneal Carcinoma

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: —
• 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 and etoposide in treating patients who have recurrent or persistent ovarian, fallopian tube, or peritoneal cancer.

Detailed description

OBJECTIVES: I. Determine the optimal dose of doxorubicin HCl liposomal and prolonged oral etoposide in patients with recurrent or persistent ovarian, tubal, and peritoneal carcinoma. II. Determine the nature and degree of toxicity of this therapy in these patients. III. Evaluate the response rate of patients with measurable disease. OUTLINE: This is a dose escalation, multicenter study of etoposide and doxorubicin HCl liposome. Patients receive doxorubicin HCl liposome IV over 1 hour on day 1, followed by oral etoposide for 8-14 days beginning on day 2. For patients who achieve partial or complete response, treatment repeats every 4 weeks for 1 year in the absence of disease progression or unacceptable toxicity. For patients with stable disease, treatment repeats every 4 weeks for 6 months. In the absence of dose limiting toxicity (DLT) in the first 3 patients treated, subsequent cohorts of 3-6 patients each receive doses of etoposide for more prolonged periods. After 14 days of oral etoposide, the dose of doxorubicin HCl liposome is escalated. The maximum tolerated dose is defined as the dose preceding that at which 2 of 6 patients experience DLT. Patients are followed every 3 months for 1 year, then until death. PROJECTED ACCRUAL: A total of 24 patients will be accrued for this study within 1 year.

Conditions

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

Interventions

Type	Name	Description
DRUG	etoposide
DRUG	pegylated liposomal doxorubicin hydrochloride

Timeline

• Start date: 1998-05-01
• Primary completion: 2002-07-01
• First posted: 2004-08-16
• Last updated: 2013-06-10

Locations

63 sites across 2 countries: United States, Canada