Gemcitabine Plus Pemetrexed Disodium in Treating Patients With Unresectable or Metastatic Biliary Tract or Gallbladder Cancer

December 5, 2016 updated by: Alliance for Clinical Trials in Oncology

Phase I/II Trial Of Gemcitabine And ALIMTA In Patients With Measurable Or Evaluable, Unresectable Or Metastatic Biliary Tract Carcinoma (Intrahepatic, Extrahepatic, Ampulla Or Vater) And Gallbladder Carcinoma

RATIONALE: Drugs used in chemotherapy such as gemcitabine work in different ways to stop tumor cells from dividing so they stop growing or die. Pemetrexed disodium may stop the growth of tumor cells by blocking the enzymes necessary for tumor cell growth. Combining gemcitabine with pemetrexed disodium may kill more tumor cells.

PURPOSE: This phase I/II trial is studying the side effects and best dose of gemcitabine when given together with pemetrexed disodium to see how well it works in treating patients with unresectable or metastatic biliary tract or gallbladder cancer.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

OBJECTIVES:

  • Determine the maximum tolerated dose of gemcitabine when administered with pemetrexed disodium in patients with unresectable or metastatic biliary tract or gallbladder cancer. (Phase I closed to accrual as of Oct. 2005.)
  • Determine the 6-month survival rate of patients treated with this regimen.
  • Determine the best objective tumor response rate and duration of best objective tumor response in patients treated with this regimen.
  • Determine the time to progression and overall survival of patients treated with this regimen.
  • Determine the toxic effects of this regimen in these patients.
  • Determine the individual patient variation in toxicity of and/or response to this regimen due to genetic differences in proteins involved in drug response in these patients.

OUTLINE: This is a multicenter phase I dose-escalation study of gemcitabine followed by a phase II study.

  • Phase I: Patients receive pemetrexed disodium IV over 10 minutes and gemcitabine IV over 30 minutes on days 1 and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity (phase I closed to accrual as of October 2005).

Cohorts of 3-6 patients receive escalating doses of gemcitabine until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity.

  • Phase II: Patients receive pemetrexed disodium as in phase I and gemcitabine at the recommended phase II dose.

Patients are followed every 3 months for 1 year and then every 6 months for 4 years.

PROJECTED ACCRUAL: A total of 85 patients will be accrued for this study.

Study Type

Interventional

Enrollment (Actual)

68

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Kansas
      • Chanute, Kansas, United States, 66720
        • Cancer Center of Kansas, PA - Chanute
      • Dodge City, Kansas, United States, 67801
        • Cancer Center of Kansas, PA - Dodge City
      • El Dorado, Kansas, United States, 67042
        • Cancer Center of Kansas, PA - El Dorado
      • Kingman, Kansas, United States, 67068
        • Cancer Center of Kansas, PA - Kingman
      • Liberal, Kansas, United States, 67901
        • Southwest Medical Center
      • Newton, Kansas, United States, 67114
        • Cancer Center of Kansas, PA - Newton
      • Parsons, Kansas, United States, 67357
        • Cancer Center of Kansas, PA - Parsons
      • Pratt, Kansas, United States, 67124
        • Cancer Center of Kansas, PA - Pratt
      • Salina, Kansas, United States, 67042
        • Cancer Center of Kansas, PA - Salina
      • Wellington, Kansas, United States, 67152
        • Cancer Center of Kansas, PA - Wellington
      • Wichita, Kansas, United States, 67203
        • Associates in Womens Health, PA - North Review
      • Wichita, Kansas, United States, 67208
        • Cancer Center of Kansas, PA - Medical Arts Tower
      • Wichita, Kansas, United States, 67214
        • Cancer Center of Kansas, PA - Wichita
      • Wichita, Kansas, United States, 67214
        • CCOP - Wichita
      • Wichita, Kansas, United States, 67214
        • Via Christi Cancer Center at Via Christi Regional Medical Center
      • Winfield, Kansas, United States, 67156
        • Cancer Center of Kansas, PA - Winfield
    • Michigan
      • Escanaba, Michigan, United States, 49431
        • Green Bay Oncology, Limited - Escanaba
      • Iron Mountain, Michigan, United States, 49801
        • Dickinson County Healthcare System
    • Minnesota
      • Burnsville, Minnesota, United States, 55337
        • Fairview Ridges Hospital
      • Coon Rapids, Minnesota, United States, 55433
        • Mercy and Unity Cancer Center at Mercy Hospital
      • Edina, Minnesota, United States, 55435
        • Fairview Southdale Hospital
      • Fridley, Minnesota, United States, 55432
        • Mercy and Unity Cancer Center at Unity Hospital
      • Maplewood, Minnesota, United States, 55109
        • Minnesota Oncology Hematology, PA - Maplewood
      • Minneapolis, Minnesota, United States, 55407
        • Virginia Piper Cancer Institute at Abbott - Northwestern Hospital
      • Robbinsdale, Minnesota, United States, 55422-2900
        • Hubert H. Humphrey Cancer Center at North Memorial Outpatient Center
      • Saint Louis Park, Minnesota, United States, 55416
        • CCOP - Metro-Minnesota
      • St. Louis Park, Minnesota, United States, 55416
        • Park Nicollet Cancer Center
      • St. Paul, Minnesota, United States, 55102
        • United Hospital
      • Waconia, Minnesota, United States, 55387
        • Ridgeview Medical Center
      • Woodbury, Minnesota, United States, 55125
        • Minnesota Oncology Hematology, PA - Woodbury
    • North Carolina
      • Rutherfordton, North Carolina, United States, 28139
        • Rutherford Hospital
    • South Carolina
      • Anderson, South Carolina, United States, 29621
        • AnMed Cancer Center
      • Spartanburg, South Carolina, United States, 29303
        • CCOP - Upstate Carolina
      • Spartanburg, South Carolina, United States, 29303
        • Gibbs Regional Cancer Center at Spartanburg Regional Medical Center
    • Wisconsin
      • Green Bay, Wisconsin, United States, 54307-3508
        • St. Vincent Hospital Regional Cancer Center
      • Green Bay, Wisconsin, United States, 54301-3526
        • Green Bay Oncology, Limited at St. Vincent Hospital Regional Cancer Center
      • Green Bay, Wisconsin, United States, 54303
        • Green Bay Oncology, Limited at St. Mary's Hospital
      • Green Bay, Wisconsin, United States, 54303
        • St. Mary's Hospital Medical Center - Green Bay
      • Marinette, Wisconsin, United States, 54143
        • Bay Area Cancer Care Center at Bay Area Medical Center
      • Oconto Falls, Wisconsin, United States, 54154
        • Green Bay Oncology, Limited - Oconto Falls
      • Sturgeon Bay, Wisconsin, United States, 54235
        • Green Bay Oncology, Limited - Sturgeon Bay

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

  • One of the following histologically or cytologically confirmed cancers not amenable to treatment with combined chemotherapy and radiotherapy:

    • Biliary tract (intrahepatic, extrahepatic, or ampulla of Vater) carcinoma
    • Gallbladder carcinoma
  • Unresectable or metastatic disease

  • No CNS metastases

    • Prior brain metastases treated with surgery or radiosurgery allowed provided treatment was completed at least 4 weeks ago and there is no evidence of CNS progression
  • No clinically significant pericardial or pleural effusion or ascites unless able to be drained before study entry
  • Performance status - ECOG 0-2
  • At least 3 months
  • Absolute neutrophil count at least 1,500/mm^3
  • Platelet count at least 100,000/mm^3
  • Bilirubin no greater than 3 times upper limit of normal (ULN)
  • AST no greater than 5 times ULN
  • Creatinine no greater than 1.5 times ULN
  • Creatinine clearance at least 45 mL/min
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer
  • Able to tolerate folic acid, corticosteroids, or cyanocobalamin supplements
  • More than 4 weeks since prior biologic or immunologic therapy
  • No prior biologic or immunologic therapy for metastatic disease
  • No concurrent immunotherapy
  • No concurrent colony-stimulating factors during course 1
  • No prior chemotherapy for metastatic disease
  • No prior gemcitabine

  • Prior chemoembolization allowed provided the following are true:

    • At least 4 weeks since prior chemoembolization
    • Evidence of new tumor growth since therapy
  • At least 6 months since prior chemotherapy used as a radiosensitizer (in adjuvant setting or for locally advanced disease)
  • No other concurrent chemotherapy

  • Prior radiofrequency ablation allowed provided the following are true:

    • At least 4 weeks since prior radiofrequency ablation
    • Evidence of new tumor growth since therapy
  • No prior radiotherapy to 25% or more of the bone marrow
  • More than 4 weeks since prior radiotherapy
  • No concurrent radiotherapy

  • Prior embolization allowed provided the following are true:

    • At least 4 weeks since prior embolization
    • Evidence of new tumor growth since therapy
  • No prior pemetrexed disodium
  • No aspirin or nonsteroidal anti-inflammatory drugs for at least 2 days (5 days for long-acting agents [e.g., piroxicam]) before, during, and for at least 2 days after administration of pemetrexed disodium
  • No concurrent cyclo-oxygenase-2 inhibitors

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: pemetrexed + gemcitabine

Phase II: Patients receive pemetrexed disodium as in phase I and gemcitabine at the recommended phase II dose.

Patients are followed every 3 months for 1 year and then every 6 months for 4 years.
Drug: gemcitabine hydrochloride
Drug: pemetrexed disodium

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Survival after 6 months of treatment
Time Frame: Up to 6 months
Up to 6 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Response as assessed by RECIST criteria every 8-16 weeks
Time Frame: Up to 16 weeks
Up to 16 weeks
Toxicity as assessed by CTC v3 every 4 weeks
Time Frame: Up to 4 weeks
Up to 4 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Alliance for Clinical Trials in Oncology

Collaborators

National Cancer Institute (NCI)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2004

Primary Completion (Actual)

February 1, 2007

Study Completion (Actual)

February 1, 2008

Study Registration Dates

First Submitted

May 6, 2003

First Submitted That Met QC Criteria

May 6, 2003

First Posted (Estimate)

May 7, 2003

Study Record Updates

Last Update Posted (Estimate)

December 7, 2016

Last Update Submitted That Met QC Criteria

December 5, 2016

Last Verified

December 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • N9943
  • NCCTG-N9943
  • CDR0000298862 (Registry Identifier: PDQ (Physician Data Query))
  • NCI-2012-02530 (Registry Identifier: CTRP (Clinical Trials Reporting System))

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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