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17-N-Allylamino-17-Demethoxygeldanamycin and Paclitaxel in Treating Patients With Metastatic or Unresectable Solid Tumor
This study is ongoing, but not recruiting participants.
Sponsors and Collaborators: UPMC Cancer Centers
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00087217
  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: This phase I trial is studying the side effects and best dose of 17-N-allylamino-17-demethoxygeldanamycin when given together with paclitaxel in treating patients with metastatic or unresectable solid tumor.


Condition Intervention Phase
Unspecified Adult Solid Tumor, Protocol Specific
Drug: paclitaxel
Drug: tanespimycin
Phase I

MedlinePlus related topics: Cancer
Drug Information available for: Paclitaxel IPI-504 17-(Allylamino)-17-demethoxygeldanamycin
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment
Official Title: Phase I Study of 17- Allylamino-17 Demethoxygeldanamycin (17-AAG) in Combination With Paclitaxel in Advanced Solid Malignancies

Further study details as provided by National Cancer Institute (NCI):

Estimated Enrollment: 35
Study Start Date: May 2004
Detailed Description:

OBJECTIVES:

  • Determine the maximum tolerated dose and recommended phase II dose of 17-N-allylamino-17-demethoxygeldanamycin (17-AAG) when administered with paclitaxel in patients with metastatic or unresectable solid malignancy.
  • Determine the dose-limiting and non-dose-limiting toxic effects of this regimen in these patients.
  • Determine the pharmacokinetics of this regimen in these patients.
  • Determine tumor response in patients treated with this regimen.

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 older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Histologically confirmed solid malignancy

    • Metastatic or unresectable disease
  • Not amenable to standard curative or palliative therapy
  • No known brain metastases

PATIENT CHARACTERISTICS:

Age

  • 18 and over

Performance status

  • ECOG 0-2

Life expectancy

  • More than 12 weeks

Hematopoietic

  • Absolute neutrophil count ≥ 1,500/mm^3
  • Platelet count ≥ 100,000/mm^3
  • WBC ≥ 3,000/mm^3

Hepatic

  • AST and ALT ≤ 2.5 times upper limit of normal
  • Bilirubin normal

Renal

  • Creatinine normal OR
  • Creatinine clearance ≥ 60 mL/min

Cardiovascular

  • QTc < 450 msec for male patients (470 msec for female patients)
  • LVEF > 40% by MUGA
  • No history of serious ventricular arrhythmia (i.e., ventricular tachycardia or ventricular fibrillation ≥ 3 beats in a row)
  • No myocardial infarction within the past year
  • No New York Heart Association class III or IV congestive heart failure
  • No poorly controlled angina
  • No history of uncontrolled dysrhythmia or requirement for antiarrhythmic drugs
  • No history of congenital long QT syndrome
  • No active ischemic heart disease within the past year
  • No left bundle branch block
  • No other significant cardiac disease

Other

  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective double barrier contraception for at least 1 week before, during, and for at least 2 weeks after study participation
  • No prior allergy to eggs
  • No prior allergic reaction to compounds of similar chemical or biologic composition to 17-AAG or paclitaxel
  • No peripheral neuropathy > grade 1
  • No concurrent uncontrolled illness
  • No active or ongoing infection
  • No psychiatric illness or social situation that would preclude study compliance

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • No concurrent granulocyte colony-stimulating factors

Chemotherapy

  • Prior paclitaxel allowed
  • More than 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin) and recovered
  • No prior 17-N-allylamino-17-demethoxygeldanamycin (17-AAG)

Endocrine therapy

  • Not specified

Radiotherapy

  • More than 4 weeks since prior radiotherapy
  • No prior radiotherapy that included the heart in the field (e.g., mantle radiotherapy)

Surgery

  • Not specified

Other

  • No concurrent combination antiretroviral therapy for HIV-positive patients
  • No concurrent therapeutic-dose warfarin for anticoagulation
  • No concurrent medications that may prolong QTc interval
  • No other concurrent investigational agents
  • No other concurrent anticancer agents or therapies
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00087217

Locations
United States, Ohio
Case Comprehensive Cancer Center
Cleveland, Ohio, United States, 44106-5065
United States, Pennsylvania
Hillman Cancer Center at University of Pittsburgh Cancer Institute
Pittsburgh, Pennsylvania, United States, 15232
Sponsors and Collaborators
UPMC Cancer Centers
Investigators
Principal Investigator: Suresh Ramalingam, MD UPMC Cancer Centers
  More Information

Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site

Publications of Results:
Study ID Numbers: CDR0000373824, PCI-03-152, PCI-IRB-0403094, NCI-6494
Study First Received: July 8, 2004
Last Updated: December 11, 2008
ClinicalTrials.gov Identifier: NCT00087217  
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
unspecified adult solid tumor, protocol specific

Study placed in the following topic categories:
Paclitaxel

Additional relevant MeSH terms:
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Therapeutic Uses
Mitosis Modulators
Tubulin Modulators
Antimitotic Agents
Antineoplastic Agents, Phytogenic
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 15, 2009