NCT00003220

Bryostatin 1 in Treating Patients With Metastatic Colorectal Cancer

Phase II Study of Bryostatin 1 in Patients With Metastatic Colo-Rectal Adenocarcinoma

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: —
• Sponsor: Barbara Ann Karmanos Cancer Institute · Academic / Other
• Sex: All
• 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. PURPOSE: Phase II trial to study the effectiveness of bryostatin 1 in treating patients with metastatic colorectal cancer.

Detailed description

OBJECTIVES: I. Determine the efficacy of bryostatin 1 administered as a 24 hour intravenous infusion every week for 3 weeks during a 4 week course of therapy in patients with colorectal cancer. II. Determine the response duration, time to progression, and survival time in this patient population. III. Determine the qualitative and quantitative toxic effects of bryostatin 1 on this schedule in this patient population. OUTLINE: Patients are treated with bryostatin 1 as a 24 hour continuous intravenous infusion weekly for 3 weeks followed by 1 week of rest. Courses are repeated every 4 weeks in the absence of unacceptable toxicity or disease progression. Patients who have no toxic effects after the completion of the first course of therapy may have the dose of bryostatin 1 escalated by 1 dose level in subsequent courses. Patients are followed for response duration and time to treatment failure. PROJECTED ACCRUAL: A total of 13-26 patients will be accrued for this study within 18 months.

Conditions

• Colorectal Cancer

Interventions

Type	Name	Description
DRUG	bryostatin 1

Timeline

• Start date: 1998-02-01
• Primary completion: 2000-11-01
• Completion: 2001-06-01
• First posted: 2004-08-13
• Last updated: 2013-04-05

Locations

2 sites across 1 country: United States