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

Inclusion 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