17-AAG and Irinotecan in Treating Patients With Locally Advanced or Metastatic Solid Tumors

Completed · Phase 1

Conditions studied: Unspecified Adult Solid Tumor, Protocol Specific

In brief

This phase I trial is studying the side effects and best dose of 17-AAG and irinotecan in treating patients with locally advanced or metastatic solid tumors. Drugs used in chemotherapy, such as 17-AAG and irinotecan, work in different ways to stop the growth of tumor cells either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells.

Key facts

Study ID

NCT00119236

Run by

National Cancer Institute (NCI)

People needed

48

Starts

2005-05-01

Last updated by the study team

2013-06-04

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Histologically confirmed solid tumor, excluding primary CNS tumors
• Locally advanced or metastatic disease that is refractory to standard therapy OR for which no standard therapy exists
• Tumor assessible for biopsy by Tru-cut\^®, CT guidance, or endoscopy (for patients treated at the maximum tolerated dose [expanded cohort only])
• Pleural effusions or abdominal ascites are not considered biopsy-accessible tissue
• No known new CNS metastases that have not been previously treated
• Performance status - Karnofsky 60-100%
• WBC ≥ 3,000/mm\^3
• Absolute neutrophil count ≥ 1,500/mm\^3
• Platelet count ≥ 100,000/mm\^3
• Bilirubin ≤ 1.5 mg/dL
• AST and ALT ≤ 3 times upper limit of normal (ULN) (5 times ULN if liver metastases are present)
• Creatinine ≤ 1.5 mg/dL
• No history of cardiac arrhythmias
• No myocardial infarction within the past 12 months
• No active ischemic heart disease within the past 12 months
• No New York Heart Association class III-IV congestive heart failure or LVEF < 40% by MUGA
• No history of uncontrolled cardiac dysrhythmia or dysrhthmias requiring medication
• No history of serious ventricular arrhythmia (i.e., ventricular tachycardia or ventricular fibrillation ≥ 3 beats in a row)
• No congenital long QT syndrome
• No left bundle branch block
• QTc < 450 msec (for male patients)
• QTc < 470 msec (for female patients)
• Not pregnant
• No nursing during and for 2 months after study participation
• Negative pregnancy test

Where it is running

• Memorial Sloan Kettering Cancer Center — New York, New York, United States

Full record on ClinicalTrials.gov

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