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