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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00005085
First received: April 6, 2000
Last updated: February 8, 2013
Last verified: December 2002
  Purpose

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.


Condition Intervention Phase
Colorectal Cancer
Drug: becatecarin
Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase II Study of Rebeccamycin Analogue NSC 655649 in Patients With Metastatic Colorectal Cancer (IMT Codes 23988, 23989, 23993)

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Enrollment: 37
Study Start Date: February 2000
Primary Completion Date: June 2002 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 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.
Drug: becatecarin

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Histologically or cytologically confirmed metastatic or locally recurrent adenocarcinoma of the colon or rectum
  • No curable stage of disease
  • At least 1 unidimensionally measurable lesion
  • At 20 mm by conventional techniques OR at least 10 mm by spiral CT scan
  • No tumor lesions in previously irradiated area except clearly measurable lesion documented histologically to be consistent with recurrent tumor in previously irradiated bed within pelvis
  • The following are considered nonmeasurable disease:

    • Bone lesions Leptomeningeal disease
    • Ascites
    • Pleural/pericardial effusion
    • Inflammatory breast disease
    • Lymphangitis cutis/pulmonis
    • Abdominal masses not confirmed and followed by imaging techniques
    • Cystic lesions
    • No known brain metastases

PATIENT CHARACTERISTICS:

  • Age: 18 and over
  • Performance status: ECOG 0-2 OR Karnofsky 60-100%
  • Life expectancy: More than 12 weeks
  • WBC at least 3,000/mm3
  • Absolute neutrophil count at least 1,500/mm3
  • Platelet count at least 100,000/mm3
  • Bilirubin normal
  • AST/ALT no greater than 2.5 times upper limit of normal
  • Creatinine normal OR creatinine clearance at least 60 mL/min
  • No symptomatic congestive heart failure
  • No unstable angina pectoris
  • No cardiac arrhythmia
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception during and for 6 months after study
  • Eligible for placement of a central venous catheter
  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00005085

Locations
United States, Georgia
Atlanta Cancer Care
Atlanta, Georgia, United States, 30342
United States, New York
Albert Einstein Comprehensive Cancer Center
Bronx, New York, United States, 10461
New York Medical College
Valhalla, New York, United States, 10595
Sponsors and Collaborators
Investigators
Study Chair: Sridhar Mani, MD Albert Einstein College of Medicine of Yeshiva University
  More Information

Additional Information:
No publications provided

Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00005085     History of Changes
Other Study ID Numbers: CDR0000067695, AECM-T99-0109, NCI-T99-0109
Study First Received: April 6, 2000
Last Updated: February 8, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by National Cancer Institute (NCI):
stage IV colon cancer
stage IV rectal cancer
recurrent colon cancer
recurrent rectal cancer
adenocarcinoma of the colon
adenocarcinoma of the rectum

Additional relevant MeSH terms:
Colorectal Neoplasms
Colonic Diseases
Digestive System Diseases
Digestive System Neoplasms
Gastrointestinal Diseases
Gastrointestinal Neoplasms
Intestinal Diseases
Intestinal Neoplasms
Neoplasms
Neoplasms by Site
Rectal Diseases

ClinicalTrials.gov processed this record on October 22, 2014