Overview

Chemotherapy in Treating Patients With Advanced Solid Tumors

Status:
Completed
Trial end date:
2002-04-01
Target enrollment:
0
Participant gender:
All
Summary
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. PURPOSE: Phase I trial to study the effectiveness of COL-3 in treating patients who have advanced solid tumors.
Phase:
Phase 1
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
The University of Texas Health Science Center at San Antonio
Collaborator:
National Cancer Institute (NCI)
Criteria
DISEASE CHARACTERISTICS: Histologically or cytopathologically proven advanced solid tumors
for which no conventional therapy exists or that is refractory to standard therapy No
primary brain tumors or active brain metastases, including known evidence of cerebral edema
by CT or MRI, known tumor progression from prior imaging studies or clinical symptoms
of/from brain metastases

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-2 Life expectancy:
Greater than 12 weeks Hematopoietic: Absolute neutrophil count greater than 1,500/mm3
Platelet count greater than 100,000/mm3 Hemoglobin greater than 9 g/dL Hepatic: Bilirubin
normal PT or PTT normal ALT or AST less than 2.5 times upper limit of normal Renal:
Creatinine less than 1.5 mg/dL OR Creatinine clearance greater than 60 mL/min
Cardiovascular: No myocardial infarction, stroke, or congestive heart failure within 3
months Other: HIV negative Not pregnant or nursing Negative pregnancy test Fertile patients
must use effective contraception No history of gastrointestinal disorders that interfere
with absorption of COL-3 No active infections or other medical illnesses No psychological
or social problems No emotional disorder or substance abuse No hypersensitivity to
tetracycline or its derivative

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: At least 4 weeks
since chemotherapy At least 6 weeks since nitrosoureas or mitomycin At least 3 months since
suramin Endocrine therapy: No concurrent steroids Radiotherapy: At least 4 weeks since
prior large field radiation therapy (greater than 20% of total bone marrow) Surgery: At
least 14 days since major surgery No major upper gastrointestinal surgery Other: No
concurrent anticonvulsant medications