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

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National Cancer Institute (NCI)

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