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

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

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 tumor. 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

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National Cancer Institute (NCI)
• Treatments: Albumin-Bound Paclitaxel; Paclitaxel

Criteria

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