Colon Cancer Clinical Trial
Rebeccamycin Analog in Treating Patients With Metastatic or Locally Recurrent Colorectal Cancer
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.
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.
Eligibility 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
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There are 3 Locations for this study
Atlanta Georgia, 30342, United States
Bronx New York, 10461, United States
Valhalla New York, 10595, United States
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