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

NCT00005085 | Completed Phase 2

• 3 other identifiers: CDR0000067695AECM-T99-0109NCI-T99-0109
• Study Type: interventional
• Target: 37
• Locations: 1 country
• Sites: 3

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.

Conditions

Colorectal Cancer

Keywords

stage IV colon cancer; stage IV rectal cancer; recurrent colon cancer; recurrent rectal cancer; adenocarcinoma of the colon; adenocarcinoma of the rectum

Study Arms (1)

Arm I

EXPERIMENTAL

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

Interventions

becatecarin DRUG

Arm I

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• National Cancer Institute (NCI): lead

Study Sites (3)

Atlanta Cancer Care

Atlanta, Georgia, 30342, United States

Location

Albert Einstein Comprehensive Cancer Center

The Bronx, New York, 10461, United States

Location

New York Medical College

Valhalla, New York, 10595, United States

Location

MeSH Terms

Conditions

Colorectal Neoplasms; Colonic Neoplasms; Rectal Neoplasms

Interventions

becatecarin

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Study Officials

• Sridhar Mani, MD

  Albert Einstein College of Medicine

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 6, 2000
• First Posted: March 16, 2004
• Study Start: February 1, 2000
• Primary Completion: June 1, 2002
• Last Updated: February 11, 2013

Record last verified: 2002-12

Locations

US (3)