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Chemotherapy in Treating Patients With Advanced Solid Tumors
This study is ongoing, but not recruiting participants.
First Received: November 1, 1999   Last Updated: July 23, 2008   History of Changes
Sponsored by: San Antonio Cancer Institute
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00003709
  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 I

Study Type: Interventional
Study Design: Treatment
Official Title: Phase I and Pharmacokinetic Study of FB-642 Administered Orally on a Weekly Schedule to Patients With Advanced Solid Tumors

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Estimated Enrollment: 35
Study Start Date: October 1998
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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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
San Antonio Cancer Institute
Investigators
Study Chair: Anthony W. Tolcher, MD San Antonio Cancer Institute
  More Information

Additional Information:
No publications provided

Study ID Numbers: CDR0000066817, UTHSC-9895011080, ILEX-FB-642-101, SACI-IDD-98-21, NCI-V98-1503
Study First Received: November 1, 1999
Last Updated: July 23, 2008
ClinicalTrials.gov Identifier: NCT00003709     History of Changes
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
unspecified adult solid tumor, protocol specific

Study placed in the following topic categories:
Anti-Infective Agents
Mecarzole
Anthelmintics

Additional relevant MeSH terms:
Anti-Infective Agents
Antiparasitic Agents
Therapeutic Uses
Mecarzole
Anthelmintics
Pharmacologic Actions
Antinematodal Agents

ClinicalTrials.gov processed this record on September 02, 2009