Gemcitabine Hydrochloride and Tanespimycin in Treating Patients With Stage IV Pancreatic Cancer

NCT00577889 | Completed Phase 2 Results DMC

• 4 other identifiers: NCI-2009-00156MC0542CDR0000445454N01CM17104
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

Brief Summary

This randomized phase II trial is studying three different schedules of gemcitabine hydrochloride and tanespimycin to see how well they work in treating patients with stage IV pancreatic cancer. Drugs used in chemotherapy, such as gemcitabine hydrochloride and tanespimycin, 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

Adenocarcinoma of the Pancreas; Recurrent Pancreatic Cancer; Stage IV Pancreatic Cancer

Outcome Measures

Primary Outcomes (1)

• Six Month Survival Rate

  A patient that is alive at 6 months is considered a treatment "success". Estimated by the number of successes divided by the total number of evaluable patients. Ninety-five percent confidence intervals for the true success proportion will be calculated according to the approach of Duffy and Santner.

  6 months

Secondary Outcomes (3)

• Overall Survival Time

  Assessed up to 2 years from registration

• Time to Disease Progression

  Time from registration to documentation of disease progression, assessed up to 2 years

• Confirmed Response Rate

  2 consecutive evaluations at least 4 weeks, up to 6 courses of treatment

Study Arms (3)

Arm I (combination chemotherapy)

EXPERIMENTAL

Patients receive 750 mg/m2 gemcitabine hydrochloride IV over 30 minutes on days 1 and 8 and 154 mg/m2 tanespimycin IV over 1 hour on day 9 of course one. Beginning with course two (and for all subsequent courses), all patients receive gemcitabine hydrochloride IV over 30 minutes on days 1 and 8 and tanespimycin IV over 1 hour on days 2 and 9.

Drug: gemcitabine hydrochloride; Drug: tanespimycin

Arm II (combination chemotherapy)

EXPERIMENTAL

Patients receive 750 mg/m2 gemcitabine hydrochloride IV over 30 minutes on days 1 and 8 and 154 mg/m2 tanespimycin IV over 1 hour on days 2 and 9 of course one. Beginning with course two (and for all subsequent courses), all patients receive gemcitabine hydrochloride IV over 30 minutes on days 1 and 8 and tanespimycin IV over 1 hour on days 2 and 9.

Drug: gemcitabine hydrochloride; Drug: tanespimycin

Arm III (combination chemotherapy)

EXPERIMENTAL

Patients receive 750 mg/m2 gemcitabine hydrochloride IV over 30 minutes on day 8 and 154 mg/m2 tanespimycin IV over 1 hour on days 1 and 9 of course one. Beginning with course two (and for all subsequent courses), all patients receive gemcitabine hydrochloride IV over 30 minutes on days 1 and 8 and tanespimycin IV over 1 hour on days 2 and 9.

Drug: gemcitabine hydrochloride; Drug: tanespimycin

Interventions

gemcitabine hydrochloride DRUG

750 mg/m2 Given IV

Also known as: dFdC, difluorodeoxycytidine hydrochloride, gemcitabine, Gemzar

Arm I (combination chemotherapy); Arm II (combination chemotherapy); Arm III (combination chemotherapy)

tanespimycin DRUG

154 mg/m2 Given IV

Also known as: 17-AAG, 17-N-Allylamino-17-Demethoxygeldanamycin

Arm I (combination chemotherapy); Arm II (combination chemotherapy); Arm III (combination chemotherapy)

Eligibility Criteria

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

You may qualify if:

• Histologically or cytologically confirmed pancreatic adenocarcinoma
• Clinical stage IV disease
• No known brain metastases
• ECOG performance status 0-2
• Life expectancy ≥ 12 weeks
• Absolute Neutrophil Count (ANC) ≥ 1,500/mm³
• Platelet count ≥ 100,000/mm³
• Total bilirubin normal
• Aspartate aminotransferase (AST) ≤ 2.5 times upper limit of normal (ULN)
• Alkaline phosphatase ≤ 2 times ULN (5 times ULN if liver metastases are present)
• Creatinine normal
• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective contraception
• Ejection fraction \> 40% by echocardiogram

Sponsors & Collaborators

• National Cancer Institute (NCI): lead

Study Sites (1)

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

MeSH Terms

Conditions

Pancreatic Neoplasms

Interventions

Gemcitabine; tanespimycin

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring

Results Point of Contact

• Title: Robert McWilliams, M.D.
• Organization: Mayo Clinic Cancer Center

McWilliams.robert@mayo.edu

Study Officials

• Robert McWilliams

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 19, 2007
• First Posted: December 20, 2007
• Study Start: March 1, 2008
• Primary Completion: January 1, 2011
• Study Completion: May 1, 2013
• Last Updated: July 25, 2014
• Results First Posted: November 25, 2013

Record last verified: 2013-09

Locations

US (1)