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Chemotherapy in Treating Patients With Advanced Solid Tumors

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00003709
First Posted: August 17, 2004
Last Update Posted: August 9, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
National Cancer Institute (NCI)
Cancer Therapy and Research Center, Texas
Information provided by (Responsible Party):
The University of Texas Health Science Center at San Antonio
  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 carbendazim in treating patients who have advanced solid tumors.


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

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase I and Pharmacokinetic Study of FB-642 Administered Orally on a Weekly Schedule to Patients With Advanced Solid Tumors

Further study details as provided by The University of Texas Health Science Center at San Antonio:

Enrollment: 25
Study Start Date: October 1998
Study Completion Date: November 2000
Primary Completion Date: November 2000 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: carbendazim
    Patients receive oral carbendazim weekly for 3 weeks followed by 1 week of rest. Treatment is repeated every 28 days in the absence of disease progression or unacceptable toxic effects. Cohorts of 3-6 patients receive escalating doses of carbendazim. If dose limiting toxicity (DLT) is seen in 1 of 3 patients treated at a given dose level, 3 additional patients will be entered at the same dose level. Dose escalation continues until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 6 patients experience DLT. Patients are followed for up to 30 days posttreatment.
Detailed Description:

OBJECTIVES: I. Determine the maximum tolerated dose of oral carbendazim in patients with advanced solid tumors. II. Determine the qualitative and quantitative toxic effects of oral carbendazim in these patients. III. Characterize the pharmacokinetic profile of oral carbendazim in these patients. IV. Assess the recommended dose of oral carbendazim to be used in phase II studies. V. Determine preliminary evidence of antitumor activity of this regimen in these patients.

OUTLINE: This is a dose escalation study. Patients receive oral carbendazim weekly for 3 weeks followed by 1 week of rest. Treatment is repeated every 28 days in the absence of disease progression or unacceptable toxic effects. Cohorts of 3-6 patients receive escalating doses of carbendazim. If dose limiting toxicity (DLT) is seen in 1 of 3 patients treated at a given dose level, 3 additional patients will be entered at the same dose level. Dose escalation continues until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 6 patients experience DLT. Patients are followed for up to 30 days posttreatment.

PROJECTED ACCRUAL: Up to 35 patients will be accrued for this study.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS: Pathologically proven advanced solid tumors for which no standard therapy exists or that has progressed or recurred following prior therapy Measurable or evaluable disease No hematological malignancies (e.g., leukemia or lymphoma) No known brain or leptomeningeal disease, unless lesions were previously irradiated, currently not being treated with corticosteroids, and have no clinical symptoms

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-2 Life expectancy: At least 12 weeks Hematopoietic: Absolute neutrophil count at least 1,500/mm3 Platelet count at least 100,000/mm3 Hemoglobin at least 9 g/dL Hepatic: Bilirubin less than 1.5 mg/dL AST or ALT no greater than 2 times upper limit of normal (ULN) (no greater than 5 times ULN if due to tumor) PT and aPTT no greater than 1.5 times ULN Renal: Creatinine no greater than 1.5 mg/dL Creatinine clearance at least 60 mL/min Cardiovascular: No unstable atrial or ventricular arrhythmias that require medication No ischemic events within 6 months Other: Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception No psychiatric disorders No history of seizure disorders No other severe concurrent disease No history of ulcers or abnormalities that would interfere with carbendazim absorption No history of hypersensitivity to PEG-formulated medications (including cyclosporine or etoposide)

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: At least 4 weeks since prior chemotherapy (6 weeks since prior nitrosoureas or mitomycin) and recovered No concurrent cytotoxic therapy Endocrine therapy: Not specified Radiotherapy: At least 4 weeks since prior radiotherapy Surgery: No prior gastrointestinal surgery that would interfere with carbendazim absorption Other: No concurrent use of phenytoin, phenobarbital, valproic acid, or other antiepileptic prophylaxis No concurrent scheduled antacids, such as H2 blockers (e.g., cimetidine or ranitidine) or hydrogen pump inhibitors (e.g., omeprazole), or cisapride

  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00003709


Locations
United States, Texas
Brooke Army Medical Center
Fort Sam Houston, Texas, United States, 78234
San Antonio Cancer Institute
San Antonio, Texas, United States, 78229
Sponsors and Collaborators
The University of Texas Health Science Center at San Antonio
National Cancer Institute (NCI)
Cancer Therapy and Research Center, Texas
Investigators
Study Chair: Anthony W. Tolcher, MD San Antonio Cancer Institute
  More Information

Responsible Party: The University of Texas Health Science Center at San Antonio
ClinicalTrials.gov Identifier: NCT00003709     History of Changes
Other Study ID Numbers: CDR0000066817
P30CA054174 ( U.S. NIH Grant/Contract )
UTHSC-9895011080 ( Other Identifier: UTHSCSA IRB )
ILEX-FB-642-101 ( Other Identifier: Proctor and Gamble )
SACI-IDD-98-21 ( Other Identifier: San Antonio Cancer Institute )
NCI-V98-1503 ( Other Identifier: NCI )
First Submitted: November 1, 1999
First Posted: August 17, 2004
Last Update Posted: August 9, 2012
Last Verified: August 2012

Keywords provided by The University of Texas Health Science Center at San Antonio:
unspecified adult solid tumor, protocol specific

Additional relevant MeSH terms:
Carbendazim
Antinematodal Agents
Anthelmintics
Antiparasitic Agents
Anti-Infective Agents