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

National Cancer Institute (NCI)

Status and phase

Completed

Phase 2

Conditions

Colorectal Cancer

Treatments

Drug: becatecarin

Study type

Interventional

Funder types

NIH

Identifiers

NCT00005085

CDR0000067695

AECM-T99-0109

NCI-T99-0109

Details and patient eligibility

About

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.

Full 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.

Enrollment

37 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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