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Phase I and Pharmacokinetic Study of FB-642 Administered Orally on a Weekly Schedule to Patients With Advanced Solid Tumors


Phase 1
18 Years
N/A
Not Enrolling
Both
Unspecified Adult Solid Tumor, Protocol Specific

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Trial Information

Phase I and Pharmacokinetic Study of FB-642 Administered Orally on a Weekly Schedule to Patients With Advanced Solid Tumors


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.

Inclusion 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

Type of Study:

Interventional

Study Design:

Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Principal Investigator

Anthony W. Tolcher, MD

Investigator Role:

Study Chair

Investigator Affiliation:

San Antonio Cancer Institute

Authority:

United States: Federal Government

Study ID:

CDR0000066817

NCT ID:

NCT00003709

Start Date:

October 1998

Completion Date:

November 2000

Related Keywords:

  • Unspecified Adult Solid Tumor, Protocol Specific
  • unspecified adult solid tumor, protocol specific
  • Neoplasms

Name

Location
Brooke Army Medical Center Fort Sam Houston, Texas  78234-6200
San Antonio Cancer Institute San Antonio, Texas  78229-3264