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Rebeccamycin Analog in Treating Patients With Metastatic or Locally Recurrent Colorectal Cancer
This study has been completed.
First Received: April 6, 2000   Last Updated: July 23, 2008   History of Changes
Sponsors and Collaborators: Albert Einstein College of Medicine of Yeshiva University
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00005085
  Purpose

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 rebeccamycin analog in treating patients who have metastatic or locally recurrent colorectal cancer.


Condition Intervention Phase
Colorectal Cancer
Drug: becatecarin
Phase II

MedlinePlus related topics: Cancer Colorectal Cancer
Drug Information available for: BMS 181176
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment
Official Title: A Phase II Study of Rebeccamycin Analogue NSC 655649 in Patients With Metastatic Colorectal Cancer (IMT Codes 23988, 23989, 23993)

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

Study Start Date: February 2000
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.

PROJECTED ACCRUAL: A total of 12-37 patients will be accrued for this study within 6-10 months.

  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 Hematopoietic: WBC at least 3,000/mm3 Absolute neutrophil count at least 1,500/mm3 Platelet count at least 100,000/mm3 Hepatic: Bilirubin normal AST/ALT no greater than 2.5 times upper limit of normal Renal: Creatinine normal OR Creatinine clearance at least 60 mL/min Cardiovascular: No symptomatic congestive heart failure No unstable angina pectoris No cardiac arrhythmia Other: 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: Biologic therapy: No concurrent prophylactic growth factors (e.g., epoetin alfa) except for clinically defined indication (e.g., filgrastim (G-CSF) for febrile neutropenia) Chemotherapy: 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 Endocrine therapy: No concurrent hormones except for clinically defined indication Radiotherapy: See Disease Characteristics 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 Surgery: Not specified Other: 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
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
Albert Einstein College of Medicine of Yeshiva University
Investigators
Study Chair: Sridhar Mani, MD Albert Einstein College of Medicine of Yeshiva University
  More Information

Additional Information:
No publications provided

Study ID Numbers: CDR0000067695, AECM-T99-0109, NCI-T99-0109
Study First Received: April 6, 2000
Last Updated: July 23, 2008
ClinicalTrials.gov Identifier: NCT00005085     History of Changes
Health Authority: United States: Federal Government

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

Study placed in the following topic categories:
Digestive System Neoplasms
Rectal Neoplasms
Gastrointestinal Diseases
Colonic Diseases
Rectal Neoplasm
Intestinal Diseases
Rectal Diseases
Recurrence
Intestinal Neoplasms
Digestive System Diseases
Rectal Cancer
Gastrointestinal Neoplasms
Adenocarcinoma
Colorectal Neoplasms

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

ClinicalTrials.gov processed this record on May 07, 2009