Rebeccamycin Analog in Treating Patients With Metastatic or Locally Recurrent Colorectal Cancer

NCT ID: NCT00005085

Last Updated: 2013-02-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 37 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2000-02-29

Brief Summary

Phase II trial to study the effectiveness of rebeccamycin analog in treating patients who have metastatic or locally recurrent colorectal cancer. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.

Detailed Description

OBJECTIVES:

I. Determine the objective response rate of patients with metastatic or locally recurrent colorectal cancer treated with rebeccamycin analogue.

II. Determine the toxicity of this regimen in this patient population. III. Determine the effect of this regimen on progression-free and overall survival in these patients.

OUTLINE: This is a multicenter study.

Patients receive rebeccamycin analogue IV once on day 1. Treatment repeats every 21 days for a maximum of 12 courses in the absence of unacceptable toxicity or disease progression. Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter.

Conditions

Colorectal Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Arm I

Patients receive rebeccamycin analogue IV once on day 1. Treatment repeats every 21 days for a maximum of 12 courses in the absence of unacceptable toxicity or disease progression. Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter.

Group Type: EXPERIMENTAL

becatecarin

Intervention Type: DRUG

Interventions

becatecarin

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• No prior allergic reactions attributed to compounds of similar chemical or biologic composition to rebeccamycin analogue
• No other uncontrolled concurrent illness
• No ongoing or active infection
• No psychiatric illness or social situation that would preclude study compliance

PRIOR CONCURRENT THERAPY:

• No concurrent prophylactic growth factors (e.g., epoetin alfa) except for clinically defined indication (e.g., filgrastim (G-CSF) for febrile neutropenia)
• At least 4 weeks since prior chemotherapy (e.g., fluorouracil, oral fluoropyrimidines, irinotecan, or oxaliplatin) (6 weeks for nitrosoureas or mitomycin)
• No other concurrent chemotherapy
• No concurrent hormones except for clinically defined indication
• At least 4 weeks since prior radiotherapy (including to bony sites, whole pelvis, lung, liver, or spinal cord/brain) and recovered
• No prior total dose of radiotherapy more than 7,000 cGy
• No prior radiotherapy to 40% or more of total bone marrow
• No prior radiotherapy to only site of measurable disease
• No concurrent radiotherapy
• Recovered from prior therapy 1 prior adjuvant treatment allowed 1 prior treatment for advanced disease allowed
• At least 4 weeks since prior investigational agents
• No other concurrent investigational antineoplastic drugs
• No other concurrent investigational agents
• No concurrent commercial agents for colorectal cancer
• No concurrent combination antiretroviral therapy for HIV-positive patients

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Sridhar Mani, MD

Role: STUDY_CHAIR

Albert Einstein College of Medicine

Locations

Atlanta Cancer Care

Atlanta, Georgia, United States

Albert Einstein Comprehensive Cancer Center

The Bronx, New York, United States

New York Medical College

Valhalla, New York, United States

Countries

United States

Other Identifiers

AECM-T99-0109

Identifier Type: -

Identifier Source: secondary_id

NCI-T99-0109

Identifier Type: -

Identifier Source: secondary_id

CDR0000067695

Identifier Type: -

Identifier Source: org_study_id