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Sponsors and Collaborators: |
Mayo Clinic National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00047047 |
RATIONALE: Drugs used in chemotherapy, such as 17-N-allylamino-17-demethoxygeldanamycin (17-AAG), gemcitabine, and cisplatin, use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells.
PURPOSE: This phase I trial is studying the side effects, best way to give, and the best dose of 17-AAG when given together with gemcitabine and/or cisplatin in treating patients with advanced solid tumors.
Condition | Intervention | Phase |
---|---|---|
Unspecified Adult Solid Tumor, Protocol Specific |
Drug: cisplatin Drug: gemcitabine hydrochloride Drug: tanespimycin |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment |
Official Title: | A Phase I Trial Of Gemcitabine, 17-Allyaminogeldanamycin (917-AAG) And Cisplatin In Advanced Solid Tumor Patients |
Estimated Enrollment: | 78 |
Study Start Date: | August 2002 |
OBJECTIVES:
NOTE: *The MTD of this 3-drug combination has been determined; cohort A closed to accrual as of 3/2/04
OUTLINE: This is a dose-escalation, cohort study of 17-N-allylamino-17-demethoxygeldanamycin (17-AAG). Patients are assigned to 1 of 3 treatment cohorts. (Cohort A closed to accrual as of 3/2/04; cohort B closed to accrual as of 3/2/05.)
NOTE: *The maximum tolerated dose (MTD) of this 3-drug combination has been determined as of 3/2/04.
NOTE: **Gemcitabine and cisplatin dosage is constant, while 17-AAG is escalated in cohorts B, C, and D.
NOTE: ***Gemcitabine dosage is constant, 17-AAG is started at a higher dose level than all other cohorts, and cisplatin dosage is escalated in cohort E.
Cohorts of 3-6 patients receive escalating doses of 17-AAG until the MTD is determined. The MTD is defined as the dose preceding that at which at least 2 of 6 patients experience dose-limiting toxicity.
In all cohorts, courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity.
Patients are followed for 3 months.
PROJECTED ACCRUAL: A total of 12 patients have been accrued for part I (cohort A closed to accrual as of 3/2/04) of this study. An additional 33-66 patients will be accrued for part II (cohorts B [closed to accrual as of 3/2/05], C, D, and E) of this study within approximately 3 years.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Cardiovascular
Pulmonary
No symptomatic pulmonary disease requiring medication including the following:
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
No concurrent prophylactic use of any of the following colony-stimulating factors:
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
United States, Minnesota | |
Mayo Clinic Cancer Center | |
Rochester, Minnesota, United States, 55905 |
Study Chair: | Charles Erlichman, MD | Mayo Clinic |
Investigator: | David O. Toft, PhD | Mayo Clinic |
Investigator: | Joel M. Reid, PhD | Mayo Clinic |
Investigator: | Matthew M. Ames, PhD | Mayo Clinic |
Investigator: | Paul Haluska, MD, PhD | Mayo Clinic |
Study ID Numbers: | CDR0000257247, MAYO-MC0111, NCI-5291 |
Study First Received: | October 3, 2002 |
Last Updated: | July 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00047047 |
Health Authority: | United States: Federal Government |
unspecified adult solid tumor, protocol specific |
Cisplatin Gemcitabine |
Antimetabolites Anti-Infective Agents Antimetabolites, Antineoplastic Molecular Mechanisms of Pharmacological Action Immunologic Factors Antineoplastic Agents Physiological Effects of Drugs |
Enzyme Inhibitors Antiviral Agents Immunosuppressive Agents Pharmacologic Actions Radiation-Sensitizing Agents Therapeutic Uses |