NCT00047047

Brief Summary

This phase I trial studies the side effects, best way to give, and best doses of tanespimycin with or without gemcitabine hydrochloride and cisplatin in treating patients with advanced solid tumors. Drugs used in chemotherapy, such as tanespimycin, gemcitabine hydrochloride, and cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Using more than one drug (combination chemotherapy) may kill more tumor cells.

Trial Health

80
On Track

Trial Health Score

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

Enrollment
78

participants targeted

Target at 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

August 1, 2002

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

October 3, 2002

Completed
4 months until next milestone

First Posted

Study publicly available on registry

January 27, 2003

Completed
4.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2007

Completed
Last Updated

June 4, 2013

Status Verified

June 1, 2013

Enrollment Period

5.1 years

First QC Date

October 3, 2002

Last Update Submit

June 3, 2013

Conditions

Unspecified Adult Solid Tumor, Protocol Specific

Outcome Measures

Primary Outcomes (2)

  • MTD of tanespimycin, gemcitabine hydrochloride, and cisplatin, determined by incidence of dose-limiting toxicity (DLT) graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0

    21 days

  • Adverse events, graded according to NCI CTCAE version 3.0

    The number and severity of all adverse events (overall, by dose-level, and by tumor group) will be tabulated and summarized within each cohort. The grade 3+ adverse events will also be described and summarized in a similar fashion. This will provide an indication of the level of tolerance for this treatment combination within each cohort. Overall toxicity incidence as well as toxicity profiles by dose level, patient and tumor site will be explored and summarized. Frequency distributions and other descriptive measures will form the basis of the analysis of these variables.

    Up to 30 days after completion of study treatment

Secondary Outcomes (2)

  • Number of responses, determined according to modified Response Evaluation Criteria in Solid Tumors (RECIST)

    Up to 3 months after completion of study treatment

  • Heat shock protein (HSP)70 and HSP90 client protein expression

    Baseline, 6, and 25 hours after start of infusion on days 1 and 8 of course 1 (cohorts B & D); prior to gemcitabine hydrochloride on day 1; pre-dose, 6, and 25 hours post-tanespimycin dose on day 2 (cohort C)

Study Arms (1)

Treatment (tanespimycin, gemcitabine hydrochloride, cisplatin)

EXPERIMENTAL

Cohort A (closed to accrual as of 3/2/04)\*: Patients receive escalating doses of gemcitabine hydrochloride intravenously (IV) over 30 minutes, tanespimycin IV over 1 hour, and cisplatin IV over 2 hours on days 1 and 8. NOTE: \*The maximum tolerated dose (MTD) of this 3-drug combination has been determined as of 3/2/04. Cohort B (closed to accrual as of 3/2/05): Patients receive gemcitabine hydrochloride\*\* IV over 30 minutes, tanespimycin IV over 1 hour, and cisplatin\*\* IV over 2 hours on days 1 and 8. Cohort C: Patients receive gemcitabine hydrochloride\*\* IV over 30 minutes and tanespimycin IV over 1-2 hours on days 2 and 9. Cohort D: Patients receive cisplatin\*\* IV over 2 hours and tanespimycin IV over 1-2 hours on days 1 and 8. Cohort E: Patients receive gemcitabine hydrochloride\*\*\*, tanespimycin\*\*\*, and cisplatin\*\*\* as in cohort B. Continued (see detailed description)

Drug: gemcitabine hydrochlorideDrug: tanespimycinDrug: cisplatinOther: laboratory biomarker analysis

Interventions

gemcitabine hydrochlorideDRUG

Given IV

Also known as: dFdC, difluorodeoxycytidine hydrochloride, gemcitabine, Gemzar
Treatment (tanespimycin, gemcitabine hydrochloride, cisplatin)
tanespimycinDRUG

Given IV

Also known as: 17-AAG
Treatment (tanespimycin, gemcitabine hydrochloride, cisplatin)
cisplatinDRUG

Given IV

Also known as: CACP, CDDP, CPDD, DDP
Treatment (tanespimycin, gemcitabine hydrochloride, cisplatin)
laboratory biomarker analysisOTHER

Correlative studies

Treatment (tanespimycin, gemcitabine hydrochloride, cisplatin)

Eligibility Criteria

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

You may qualify if:

  • Histologic proof of cancer that is now considered clinically unresectable
  • Absolute neutrophil count (ANC) \>= 1500/uL
  • Platelets (PLT) \>= 100,000/uL
  • Total bilirubin =\< 2 x upper limit of normal (ULN)
  • Aspartate aminotransferase (AST) =\< 2.5 x ULN
  • Creatinine =\< 1.5 x ULN
  • Alkaline phosphatase =\< 2 x ULN or =\< 5 x ULN if liver involvement
  • Hemoglobin (Hgb) \>= 9.0 g/dL
  • Ability to provide informed consent
  • Willingness to return to Mayo Clinic Rochester for follow up
  • Life expectancy \>= 12 weeks
  • Willingness to provide all biologic specimens as required by the protocol; this is the mandatory translational research component
  • Prior treatment with gemcitabine or cisplatin or both is allowed
  • Patients who have had prior anthracycline must have a normal ejection fraction on multi gated acquisition scan (MUGA)
  • Women of childbearing potential only: negative serum pregnancy test done =\< 7 days prior to registration

You may not qualify if:

  • Known standard therapy for the patient's disease that is potentially curative or definitely capable of extending life expectancy
  • ECOG performance status (PS) 2, 3 or 4
  • Uncontrolled infection
  • Any of the following prior therapies:
  • Chemotherapy =\< 4 weeks prior to study entry
  • Mitomycin C/nitrosoureas =\< 6 weeks prior to study entry
  • Immunotherapy =\< 4 weeks prior to study entry
  • Biologic therapy =\< 4 weeks prior to study entry
  • Radiation therapy =\< 4 weeks prior to study entry, or any radiation that potentially included the heart in the field (e.g., mantle)
  • Radiation to \> 25% of bone marrow
  • Radiopharmaceuticals
  • Chest radiation
  • Failure to fully recover from acute, reversible effects of prior chemotherapy regardless of interval since last treatment
  • Significant cardiac disease including:
  • Heart failure that meets New York Heart Association classification III or IV
  • +21 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

MeSH Terms

Interventions

GemcitabinetanespimycinCisplatin

Intervention Hierarchy (Ancestors)

Heterocyclic CompoundsDeoxycytidineCytidinePyrimidine NucleosidesPyrimidinesHeterocyclic Compounds, 1-RingChlorine CompoundsInorganic ChemicalsNitrogen CompoundsPlatinum Compounds

Study Officials

  • Charles Erlichman

    Mayo Clinic

    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

October 3, 2002

First Posted

January 27, 2003

Study Start

August 1, 2002

Primary Completion

September 1, 2007

Last Updated

June 4, 2013

Record last verified: 2013-06

Locations

US(1)