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

NCT00119236 | Completed Phase 1

• 6 other identifiers: NCI-2012-0146705-017MSKCC-IRB-05017NCI-7009CDR0000434501U01CA069856
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Unspecified Adult Solid Tumor, Protocol Specific

Outcome Measures

Primary Outcomes (1)

• Maximum tolerated dose determined by dose-limiting toxicities

  21 days

Study Arms (1)

Arm I

EXPERIMENTAL

Patients receive irinotecan IV over 30 minutes followed by 17-N-allylamino-17-demethoxygeldanamycin (17-AAG)\* IV over 2 hours on days 1 and 8. Treatment repeats every 21 days for at least 2 courses in the absence of disease progression or unacceptable toxicity. Patients achieving stable or improved disease after course 2 may receive additional courses of treatment.

Drug: tanespimycin; Drug: irinotecan hydrochloride

Interventions

tanespimycin DRUG

Also known as: 17-AAG

Arm I

irinotecan hydrochloride DRUG

Also known as: Campto, Camptosar, CPT-11, irinotecan, U-101440E

Arm I

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• National Cancer Institute (NCI): lead

Study Sites (1)

Memorial Sloan Kettering Cancer Center

New York, New York, 10065, United States

Location

MeSH Terms

Interventions

tanespimycin; Irinotecan

Intervention Hierarchy (Ancestors)

Camptothecin; Alkaloids; Heterocyclic Compounds

Study Officials

• Archie Tse

  Memorial Sloan Kettering Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 12, 2005
• First Posted: July 13, 2005
• Study Start: May 1, 2005
• Primary Completion: October 1, 2008
• Last Updated: June 4, 2013

Record last verified: 2013-06

Locations

US (1)