ClinicalTrials.gov
skipnavHome|Search|Browse|Resources|Help|What's New|About

17-N-Allylamino-17-Demethoxygeldanamycin and Paclitaxel in Treating Patients With Metastatic or Unresectable Solid Tumor

This study is currently recruiting patients.

Sponsored by: University of Pittsburgh Cancer Institute
Information provided by: National Cancer Institute (NCI)

Purpose

RATIONALE: Drugs used in chemotherapy, such as 17-N-allylamino-17-demethoxygeldanamycin and paclitaxel, work in different ways to stop tumor cells from dividing so they stop growing or die. Combining 17-N-allylamino-17-demethoxygeldanamycin with paclitaxel may kill more tumor cells.

PURPOSE: Phase I trial to study the effectiveness of combining 17-N-allylamino-17-demethoxygeldanamycin with paclitaxel in treating patients who have metastatic or unresectable solid tumor.

Condition Treatment or Intervention Phase
unspecified adult solid tumor, protocol specific
 Drug: 17-N-allylamino-17-demethoxygeldanamycin
 Drug: paclitaxel
 Procedure: chemotherapy
Phase I

MedlinePlus related topics:  Cancer;   Cancer Alternative Therapy

Study Type: Interventional
Study Design: Treatment

Official Title: Phase I Study of 17-N-Allylamino-17-Demethoxygeldanamycin (17-AAG) and Paclitaxel in Patients With Metastatic or Unresectable Solid Malignancy

Further Study Details: 

OBJECTIVES:

OUTLINE: This is a multicenter, dose-escalation study of 17-N-allylamino-17-demethoxygeldanamycin (17-AAG).

Patients receive 17-AAG IV over 1 hour on days 1*, 4, 8, 11, 15 and 18 and paclitaxel IV over 1 hour on days 1, 8, and 15. Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity.

NOTE: *17-AAG is not administered on day 1 of course 1.

Cohorts of 3-6 patients receive escalating doses of 17-AAG until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. Once the MTD is determined, 6-12 patients are treated at the recommended phase II dose.

PROJECTED ACCRUAL: A total of 6-35 patients will be accrued for this study within 2-11.7 months.

Eligibility

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both

Criteria

DISEASE CHARACTERISTICS:

PATIENT CHARACTERISTICS: Age

Performance status

Life expectancy

Hematopoietic

Hepatic

Renal

Cardiovascular

Other

PRIOR CONCURRENT THERAPY: Biologic therapy

Chemotherapy

Endocrine therapy

Radiotherapy

Surgery

Other


Location and Contact Information


Ohio
      Ireland Cancer Center, Cleveland,  Ohio,  44106-5065,  United States; Recruiting
Scot C. Remick, MD  216-844-1210 

Pennsylvania
      Hillman Cancer Center at University of Pittsburgh Cancer Institute, Pittsburgh,  Pennsylvania,  15232,  United States; Recruiting
Sakkaraiappan Ramalingam, MD  412-692-4724    ramalingams@upmc.edu 

Study chairs or principal investigators

Sakkaraiappan Ramalingam, MD,  Principal Investigator,  University of Pittsburgh Cancer Institute   

More Information

Clinical trial summary from the National Cancer Institute's PDQ® database

Study ID Numbers:  CDR0000373824; PCI-03-152; PCI-IRB-0403094; NCI-6494
Record last reviewed:  July 2004
Record first received:  July 8, 2004
ClinicalTrials.gov Identifier:  NCT00087217
Health Authority: Unspecified
ClinicalTrials.gov processed this record on 2004-10-29
line
U.S. National Library of Medicine, Contact NLM Customer Service
National Institutes of Health, Department of Health & Human Services
Copyright, Privacy, Accessibility, Freedom of Information Act