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A Phase II Study of Rebeccamycin Analogue NSC 655649 in Patients With Metastatic Colorectal Cancer (IMT Codes 23988, 23989, 23993)

Phase 2
18 Years
Not Enrolling
Colorectal Cancer

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Trial Information

A Phase II Study of Rebeccamycin Analogue NSC 655649 in Patients With Metastatic Colorectal Cancer (IMT Codes 23988, 23989, 23993)


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.

Inclusion Criteria


- 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


- 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


- 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

- 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

Type of Study:


Study Design:

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Principal Investigator

Sridhar Mani, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Albert Einstein College of Medicine of Yeshiva University


United States: Food and Drug Administration

Study ID:




Start Date:

February 2000

Completion Date:

Related Keywords:

  • Colorectal Cancer
  • stage IV colon cancer
  • stage IV rectal cancer
  • recurrent colon cancer
  • recurrent rectal cancer
  • adenocarcinoma of the colon
  • adenocarcinoma of the rectum
  • Colorectal Neoplasms



Albert Einstein Comprehensive Cancer Center Bronx, New York  10461
New York Medical College Valhalla, New York  10595
Atlanta Cancer Care Atlanta, Georgia  30342