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A Phase I, Pharmacologic and Biologic Study of Col-3 (NSC683551) Administered on a 28-Day Oral Dosing Schedule in Patients With Advanced Solid Tumors

Phase 1
18 Years
Not Enrolling
Unspecified Adult Solid Tumor, Protocol Specific

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Trial Information

A Phase I, Pharmacologic and Biologic Study of Col-3 (NSC683551) Administered on a 28-Day Oral Dosing Schedule in Patients With Advanced Solid Tumors

OBJECTIVES: I. Define the maximum tolerated dose of COL-3 in patients with advanced solid
tumors. II. Identify the dose limiting toxicity and safety profile of COL-3 in these
patients. III. Define the pharmacokinetics and pharmacodynamics of COL-3 in these patients.
IV. Observe any evidence of antitumor activity through standard response criteria or
biologic surrogate markers.

OUTLINE: This is a dose escalation study. Patients receive oral COL-3 once daily. Treatment
continues in the absence of disease progression and unacceptable toxic effects. Cohorts of
3-6 patients each receive escalating doses of COL-3. Dose escalation to the next level
occurs after 3 patients have completed 28 days of treatment without dose limiting toxicity
(DLT). Dose escalation continues until the maximum tolerated dose (MTD) is determined. The
MTD is defined as the dose preceding that at which 2 or more of 6 patients experience DLT.

PROJECTED ACCRUAL: Up to 30 patients will be accrued within 1 year for this study.

Inclusion Criteria

DISEASE CHARACTERISTICS: Histologically or cytopathologically proven advanced solid tumors
for which no conventional therapy exists or that is refractory to standard therapy No
primary brain tumors or active brain metastases, including known evidence of cerebral
edema by CT or MRI, known tumor progression from prior imaging studies or clinical
symptoms of/from brain metastases

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-2 Life expectancy:
Greater than 12 weeks Hematopoietic: Absolute neutrophil count greater than 1,500/mm3
Platelet count greater than 100,000/mm3 Hemoglobin greater than 9 g/dL Hepatic: Bilirubin
normal PT or PTT normal ALT or AST less than 2.5 times upper limit of normal Renal:
Creatinine less than 1.5 mg/dL OR Creatinine clearance greater than 60 mL/min
Cardiovascular: No myocardial infarction, stroke, or congestive heart failure within 3
months Other: HIV negative Not pregnant or nursing Negative pregnancy test Fertile
patients must use effective contraception No history of gastrointestinal disorders that
interfere with absorption of COL-3 No active infections or other medical illnesses No
psychological or social problems No emotional disorder or substance abuse No
hypersensitivity to tetracycline or its derivative

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: At least 4 weeks
since chemotherapy At least 6 weeks since nitrosoureas or mitomycin At least 3 months
since suramin Endocrine therapy: No concurrent steroids Radiotherapy: At least 4 weeks
since prior large field radiation therapy (greater than 20% of total bone marrow) Surgery:
At least 14 days since major surgery No major upper gastrointestinal surgery Other: No
concurrent anticonvulsant medications

Type of Study:


Study Design:

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

Principal Investigator

Eric K. Rowinsky, MD

Investigator Role:

Study Chair

Investigator Affiliation:

San Antonio Cancer Institute


United States: Food and Drug Administration

Study ID:




Start Date:

November 1998

Completion Date:

April 2002

Related Keywords:

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



San Antonio Cancer Institute San Antonio, Texas  78229-3264