NCT00087217

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 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

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
35

participants targeted

Target at P50-P75 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2004

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

July 8, 2004

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 12, 2004

Completed
3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2008

Completed
Last Updated

January 25, 2013

Status Verified

January 1, 2013

Enrollment Period

4.1 years

First QC Date

July 8, 2004

Last Update Submit

January 24, 2013

Conditions

Unspecified Adult Solid Tumor, Protocol Specific

Outcome Measures

Primary Outcomes (1)

  • Phase 2 recommended doses of tanespimycin

    Tabulated according to the NCI CTC.

    28 days

Study Arms (1)

Treatment (tanespimycin, paclitaxel)

EXPERIMENTAL

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.

Drug: tanespimycinDrug: paclitaxelOther: laboratory biomarker analysisOther: pharmacological study

Interventions

tanespimycinDRUG

Given IV

Also known as: 17-AAG
Treatment (tanespimycin, paclitaxel)
paclitaxelDRUG

Given IV

Also known as: Anzatax, Asotax, TAX, Taxol
Treatment (tanespimycin, paclitaxel)
laboratory biomarker analysisOTHER

Correlative studies

Treatment (tanespimycin, paclitaxel)
pharmacological studyOTHER

Correlative studies

Also known as: pharmacological studies
Treatment (tanespimycin, paclitaxel)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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
  • +29 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Pennsylvania Medical Center

Philadelphia, Pennsylvania, 19104, United States

Location

MeSH Terms

Interventions

tanespimycinPaclitaxelTaxes

Intervention Hierarchy (Ancestors)

TaxoidsCyclodecanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsDiterpenesTerpenesEconomicsHealth Care Economics and Organizations

Study Officials

  • Suresh Ramalingam

    University of Pennsylvania Medical 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 8, 2004

First Posted

July 12, 2004

Study Start

May 1, 2004

Primary Completion

June 1, 2008

Last Updated

January 25, 2013

Record last verified: 2013-01

Locations

US(1)