Chemotherapy in Treating Patients With Solid Tumors

NCT00003698 | Completed Phase 1

• 3 other identifiers: CDR0000066805CRC-PHASE-I/II-PH1/066EU-98066
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Unspecified Adult Solid Tumor, Protocol Specific

Keywords

unspecified adult solid tumor, protocol specific

Interventions

fosbretabulin disodium DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• University of Glasgow: lead

Study Sites (1)

Mount Vernon Hospital

Northwood, England, HA6 2RN, United Kingdom

Location

Related Publications (2)

• Galbraith SM, Taylor NJ, Maxwell RJ, et al.: Combretastatin A4 phosphate (CA4P) targets vasculature in animal and human tumors. [Abstract] Br J Cancer 83 (suppl 1): A-1.7, 12, 2000.

  BACKGROUND

• Rustin GJ, Galbraith SM, Anderson H, Stratford M, Folkes LK, Sena L, Gumbrell L, Price PM. Phase I clinical trial of weekly combretastatin A4 phosphate: clinical and pharmacokinetic results. J Clin Oncol. 2003 Aug 1;21(15):2815-22. doi: 10.1200/JCO.2003.05.185. Epub 2003 Jun 13.

  PMID: 12807934 RESULT

MeSH Terms

Interventions

fosbretabulin

Study Officials

• Gordon J.S. Rustin, MD

  Mount Vernon Cancer Centre at Mount Vernon Hospital

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Purpose: TREATMENT
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: November 1, 1999
• First Posted: May 20, 2004
• Study Start: July 1, 1998
• Study Completion: December 1, 2003
• Last Updated: December 19, 2013

Record last verified: 2008-02

Locations

GB (1)