Combretastatin A4 Phosphate in Treating Patients With Advanced Solid Tumors

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Case Comprehensive Cancer Center
ClinicalTrials.gov Identifier:
NCT00003768
First received: April 6, 2000
Last updated: January 6, 2014
Last verified: January 2014
  Purpose

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 solid tumors that have not responded to previous therapy.


Condition Intervention Phase
Unspecified Adult Solid Tumor, Protocol Specific
Drug: fosbretabulin disodium
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase I Pharmacokinetic Study of Single Dose Intravenous CA4P in Patients With Advanced Cancer

Resource links provided by NLM:


Further study details as provided by Case Comprehensive Cancer Center:

Enrollment: 25
Study Start Date: September 1998
Study Completion Date: July 2001
Primary Completion Date: July 2001 (Final data collection date for primary outcome measure)
Detailed Description:

OBJECTIVES: I. Determine the maximum tolerated dose of combretastatin A4 phosphate when administered at single doses every 21 days in patients with advanced solid tumors. II. Determine both the toxicity and dose limiting toxicity of this regimen in these patients. III. Determine the plasma and urine pharmacokinetics of combretastatin A4 and combretastatin A4 phosphate. IV. Gather preliminary data regarding possible antitumor effects in those patients with measurable disease.

OUTLINE: This is an open label, dose escalation study. Patients receive combretastatin A4 phosphate IV over 10-60 minutes. Treatment repeats every 3 weeks in the absence of unacceptable toxicity or disease progression. Cohorts of 3-6 patients receive escalating doses of combretastatin A4 phosphate until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose limiting toxicity. Patients are followed at 3 weeks.

PROJECTED ACCRUAL: A maximum of 21 patients will be accrued for this study.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS: Histologically or cytologically proven advanced solid tumors that have failed standard therapy or for which no curative therapy exists No leukemia, lymphoma, or multiple myeloma No brain metastases

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-2 Life expectancy: At least 12 weeks Hematopoietic: WBC at least 3,000/mm3 Granulocyte count at least 1,500/mm3 Platelet count at least 100,000/mm3 Hemoglobin at least 9.0 g/dL Hepatic: Bilirubin normal SGOT/SGPT no greater than 3 times upper limit of normal (ULN) PT/PTT less than ULN OR International normalized ratio (INR) less than 1.1 Renal: Creatinine no greater than 2.0 mg/dL OR Creatinine clearance greater than 60 mL/min Cardiovascular: No clear evidence of acute ischemic heart disease on EKG No history of myocardial infarction within past 6 months No history of angina No peripheral vascular disorder Neurologic: No active seizure disorder Other: Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception No evidence of hematemesis, melena, or hematochezia No history of inflammatory bowel disease, autoimmune disease, or bleeding disorders No Type I diabetes mellitus or Type II diabetes with peripheral vascular disorders No active infections or any serious concurrent systemic disorders incompatible with study

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: At least 4 weeks since prior chemotherapy (6 weeks for mitomycin and nitrosoureas) and recovered No other concurrent cytotoxic therapy Endocrine therapy: Not specified Radiotherapy: At least 4 weeks since prior radiotherapy and recovered Surgery: At least 6 weeks since prior major surgery Other: At least 4 weeks since any other prior investigational agent No concurrent anticonvulsant therapy No concurrent aspirin greater than 100 mg per day, heparin, or nonsteroidal antiinflammatory medication No concurrent calcium channel blockers, antiarrhythmias, or anti-angina therapy Concurrent beta-blocking agents for hypertension or anxiety allowed

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00003768

Locations
United States, Ohio
Ireland Cancer Center
Cleveland, Ohio, United States, 44106-5065
Sponsors and Collaborators
Case Comprehensive Cancer Center
Investigators
Study Chair: Scot C. Remick, MD Case Comprehensive Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: Case Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT00003768     History of Changes
Other Study ID Numbers: ILEX1Y98, CWRU-ILEX-1Y98, ILEX-1Y98, ILEX-CA4P101-A3, NCI-G99-1502
Study First Received: April 6, 2000
Last Updated: January 6, 2014
Health Authority: United States: Federal Government

Keywords provided by Case Comprehensive Cancer Center:
unspecified adult solid tumor, protocol specific

Additional relevant MeSH terms:
Fosbretabulin
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on October 19, 2014