NCT00121264

17-AAG and Sorafenib in Treating Patients With Unresectable or Metastatic Solid Tumors

A Phase I Dose-Escalation Study of Intravenous 17-Allylaminogeldanamycin (17-AAG) [NSC 330507and Oral BAY 43-9006 [NSC 724772] Administered in Patients With Pretreated Advanced Solid Tumors

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 54 (actual)
• Sponsor: National Cancer Institute (NCI) · NIH
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This phase I trial is studying the side effects and best dose of 17-AAG when given together with sorafenib in treating patients with unresectable or metastatic solid tumors. Drugs used in chemotherapy, such as 17-AAG, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Sorafenib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor. Giving 17-AAG together with sorafenib may kill more tumor cells.

Detailed description

PRIMARY OBJECTIVES: I. To recommend a phase II dose for 17AAG (once weekly intravenously for 3 of 4 weeks), in combination with BAY 43-9006 (twice daily orally), by determining the feasibility, safety, dose limiting toxicities and the maximally tolerated dose. SECONDARY OBJECTIVES: I. To evaluate the modulation of pharmacodynamic effects and to investigate the interaction between the two mechanisms of action when used in combination by: Studying surrogate tissue and tumor cell signaling by Western blotting. Evaluating tumor blood flow utilizing dynamic contrast enhanced MRI. II. To study any pharmacokinetic interactions between these two agents. III. To assess preliminary anti-tumor activity of this combination. OUTLINE: This is an open-label, multicenter, dose-escalation study of 17-N-allylamino 17-demethoxygeldanamycin (17-AAG). Patients receive oral sorafenib twice daily on days -14 to 28 in course 1 and on days 1-28 in all subsequent courses. Patients also receive 17-AAG IV over 3 hours on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Cohorts of 5-6 patients receive escalating doses of 17-AAG until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that which 2 of 6 patients experience dose-limiting toxicity. After completion of study therapy, patients are followed for 60 days.

Conditions

• Unspecified Adult Solid Tumor, Protocol Specific

Interventions

Type	Name	Description
DRUG	sorafenib tosylate	Given orally
DRUG	tanespimycin	Given IV
OTHER	laboratory biomarker analysis	Correlative studies
OTHER	pharmacological study	Correlative studies
PROCEDURE	magnetic resonance imaging	Correlative studies

Timeline

• Start date: 2005-03-01
• Primary completion: 2010-07-01
• Completion: 2010-07-01
• First posted: 2005-07-21
• Last updated: 2014-06-17

Locations

1 site across 1 country: United States