NCT00021372

Paclitaxel and Estramustine in Treating Patients With Relapsed or Refractory Non-Hodgkin's Lymphoma

Phase II Study of Paclitaxel and Estramustine Phosphate in Patients With Relapsed Non-Hodgkin's Lymphoma

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 25 (actual)
• Sponsor: Fox Chase Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Combining more than one drug may kill more cancer cells. PURPOSE: Phase II trial to study the effectiveness of combining paclitaxel and estramustine in treating patients who have relapsed or refractory non-Hodgkin's lymphoma.

Detailed description

OBJECTIVES: I. Determine the response rate, time to treatment failure, and overall survival of patients with relapsed or refractory non-Hodgkin's lymphoma treated with paclitaxel and estramustine. II. Determine the toxicity of this regimen in this patient population. OUTLINE: Patients receive oral estramustine 2-3 times daily on days 1-3 and paclitaxel IV over 1 hour on day 2 on weeks 1-6. Treatment repeats every 8 weeks for at least 1 course in the absence of disease progression or unacceptable toxicity. Patients achieving a complete or partial response continue therapy for at least 3 courses or for 1 course after achieving maximum response. Patients are followed every 3 months. PROJECTED ACCRUAL: A total of 18-35 patients will be accrued for this study.

Conditions

• Lymphoma

Interventions

Type	Name	Description
DRUG	estramustine phosphate sodium
DRUG	paclitaxel

Timeline

• Start date: 1996-02-01
• Primary completion: 2006-09-01
• Completion: 2006-09-01
• First posted: 2004-02-27
• Last updated: 2013-07-10

Locations

17 sites across 1 country: United States