Chemotherapy in Treating Patients With Advanced Solid Tumors

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

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 COL-3 in treating patients who have advanced solid tumors.

Study Overview

• Status: Completed
• Conditions: Unspecified Adult Solid Tumor, Protocol Specific
• Intervention / Treatment: Drug: incyclinide

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 33
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Texas
    • San Antonio, Texas, United States, 78229-3264
      • San Antonio Cancer Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Collaborators and Investigators

• Sponsor: The University of Texas Health Science Center at San Antonio
• Collaborators: National Cancer Institute (NCI)
• Investigators: Study Chair: Eric K. Rowinsky, MD, San Antonio Cancer Institute

Study record dates

Study Major Dates

• Study Start: November 1, 1998
• Primary Completion (Actual): April 1, 2002
• Study Completion (Actual): April 1, 2002

Study Registration Dates

• First Submitted: November 1, 1999
• First Submitted That Met QC Criteria: February 6, 2004
• First Posted (Estimate): February 9, 2004

Study Record Updates

• Last Update Posted (Estimate): June 29, 2012
• Last Update Submitted That Met QC Criteria: June 27, 2012
• Last Verified: June 1, 2012

More Information

Terms related to this study

• Keywords: unspecified adult solid tumor, protocol specific
• Additional Relevant MeSH Terms: Neoplasms
• Other Study ID Numbers: CDR0000066830; P30CA054174 (U.S. NIH Grant/Contract); U01CA069853 (U.S. NIH Grant/Contract); UTHSC-9785011153 (Other Identifier: UTHSCSA IRB); SACI-IDD-97-27 (Other Identifier: San Antonio Cancer Institute); NCI-T97-0091 (Other Identifier: NCI)