NCT00004864

Docetaxel and GEM 231 in Treating Patients With Recurrent or Refractory Solid Tumors

A Phase I Open-Label Safety Study of Escalating Doses of Taxotere in Combination With Escalating Doses of GEM231 in Patients With Refractory Solid Tumors

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: —
• Sponsor: Montefiore Medical Center · Academic / Other
• 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. Gene therapy such as GEM 231 may inhibit the growth of cancer cells and make the tumor more sensitive to chemotherapy. PURPOSE: Phase I trial to study the effectiveness of combining docetaxel and GEM 231 in treating patients who have recurrent or refractory solid tumors.

Detailed description

OBJECTIVES: I. Determine the safety and maximum tolerated dose of docetaxel and GEM 231 in patients with recurrent or refractory solid tumors. II. Determine any preliminary antitumor activity of GEM 231 in this patient population. OUTLINE: This is a dose escalation study of GEM 231 and docetaxel. Patients receive docetaxel IV over 1 hour on day 1, immediately followed by GEM 231 IV over 2 hours on days 1, 4, 8, and 11. Treatment continues every 3 weeks in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients are treated with escalating doses of GEM 231 and docetaxel until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose at which no more than 2 of 6 patients experience dose limiting toxicity. Patients are followed monthly for 3 months. PROJECTED ACCRUAL: A maximum of 1 patient will be accrued per week for this study until the maximum tolerated dose is reached.

Conditions

• Unspecified Adult Solid Tumor, Protocol Specific

Interventions

Type	Name	Description
DRUG	GEM 231
DRUG	docetaxel

Timeline

• Start date: 1999-07-01
• Primary completion: 2000-06-01
• Completion: 2000-06-01
• First posted: 2004-03-15
• Last updated: 2018-09-10

Locations

1 site across 1 country: United States