Overview

Chemotherapy in Treating Patients With Solid Tumors

Status:
Completed
Trial end date:
2003-12-01
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 combretastatin A4 phosphate in treating patients who have advanced malignant solid tumors.
Phase:
Phase 1
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
University of Glasgow
Treatments:
Fosbretabulin
Criteria
DISEASE CHARACTERISTICS: Histologically confirmed solid tumor that is not amenable to any
standard curative therapy or is refractory to conventional therapy Tumor suitable for MRI
or PET imaging No active brain metastases

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: WHO 0-2 Life expectancy: At
least 4 months Hematopoietic: WBC at least 4,000/mm3 Platelet count at least 100,000/mm3
Hemoglobin at least 10 g/dL Hepatic: Bilirubin less than 1.17 mg/dL ALT or AST less than 2
times upper limit of normal (ULN) Alkaline phosphatase less than 2 times ULN (unless due to
liver or bone metastases) Renal: Creatinine less than 1.5 mg/dL Cardiovascular: No ischemic
heart disease Other: Not pregnant or nursing Fertile patients must use effective
contraception at least 4 weeks before, during, and for 4 weeks after the study No other
serious medical condition or serious infection within past 28 days No other active
concurrent malignancies, except: Carcinoma in situ of the cervix Adequately treated basal
or squamous cell carcinoma of the skin No autoimmune disorders No inflammatory bowel
disease No diabetes

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: At least 6 weeks
since prior nitrosoureas or mitomycin and recovered Endocrine therapy: Concurrent steroid
use allowed Radiotherapy: At least 6 weeks since prior radiotherapy (except radiotherapy to
small isolated fields not including significant areas of bone marrow) and recovered No
prior radiotherapy to tumor site(s) that will be imaged by MRI/PET scanning or used to
assess tumor response Surgery: No concurrent open surgery Other: At least 4 weeks since all
other prior anticancer therapies and recovered No concurrent heparin or warfarin Concurrent
NSAIDs allowed