Status:
COMPLETED
17-N-Allylamino-17-Demethoxygeldanamycin and Paclitaxel in Treating Patients With Metastatic or Unresectable Solid Tumor
Lead Sponsor:
National Cancer Institute (NCI)
Conditions:
Unspecified Adult Solid Tumor, Protocol Specific
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
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...
Detailed Description
OBJECTIVES: I. 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...
Eligibility Criteria
Inclusion
- Inclusion Criteria:
- Histologically confirmed solid malignancy
- Metastatic or unresectable disease
- Not amenable to standard curative or palliative therapy
- No known brain metastases
- Performance status - ECOG 0-2
- More than 12 weeks
- Absolute neutrophil count ≥ 1,500/mm\^3
- Platelet count ≥ 100,000/mm\^3
- WBC ≥ 3,000/mm\^3
- AST and ALT ≤ 2.5 times upper limit of normal
- Bilirubin normal
- Creatinine normal
- Creatinine clearance ≥ 60 mL/min
- 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
- 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
- No concurrent granulocyte colony-stimulating factors
- 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)
- More than 4 weeks since prior radiotherapy
- No prior radiotherapy that included the heart in the field (e.g., mantle radiotherapy)
- 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
Exclusion
Key Trial Info
Start Date :
May 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
35 Patients enrolled
Trial Details
Trial ID
NCT00087217
Start Date
May 1 2004
Last Update
January 25 2013
Active Locations (1)
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1
University of Pennsylvania Medical Center
Philadelphia, Pennsylvania, United States, 19104