NCT00003713

Chemotherapy in Treating Patients With Advanced or Metastatic Solid Tumors

A Phase I, Pharmacokinetic, and Treatment Duration and Escalation Study of Intravenous Intoplicine Administered as a 5 to 21-Day Continuous Infusion Every 4 Weeks

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 35 (estimated)
• Sponsor: Genzyme, a Sanofi Company · Industry
• Sex: All
• Age: 18 Years – 120 Years
• Healthy volunteers: Not accepted

Summary

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 intoplicine in treating patients who have advanced or metastatic solid tumors.

Detailed description

OBJECTIVES: I. Determine the intolerable dose level of intoplicine in patients with locally advanced or metastatic cancer. II. Determine recommended phase II dose of intoplicine in these patients. III. Determine the principal and dose limiting toxicities of intoplicine in these patients, and determine the duration and reversibility of the toxicities. IV. Determine the magnitude of plasma concentrations that are achieved and maintained on this regimen and relate this parameter to toxicity outcome and antitumor activity. V. Determine preliminary evidence of antitumor activity of intoplicine in these patients. OUTLINE: This is a dose escalation study. The first 3 patients receive intoplicine IV by continuous infusion for 5 days. Treatment is repeated every 28 days in the absence of disease progression or unacceptable toxicity. Subsequent cohorts of 3-6 patients receive escalating doses of intoplicine, first by increasing the number of days that the drug is infused to 10, 15, and 21, then by increasing the dosage and keeping the infusion time constant at 21 days. The intolerable dose level is defined as the lowest dose at which at least 2 of 3 or 6 patients experience dose limiting toxicity during course 1 or 2. PROJECTED ACCRUAL: A total of 20-35 patients will be accrued for this study.

Conditions

• Unspecified Adult Solid Tumor, Protocol Specific

Interventions

Type	Name	Description
DRUG	intoplicine

Timeline

• Start date: 1997-08-01
• First posted: 2004-05-03
• Last updated: 2018-08-29

Locations

3 sites across 2 countries: United States, Canada