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Extrahepatic Bile Duct CancerPhase 1/2NCT00059865

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

A Phase 1/2 study testing gemcitabine hydrochloride and pemetrexed disodium in people with Extrahepatic Bile Duct Cancer and Gallbladder Cancer, run by Alliance for Clinical Trials in Oncology at 41 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
gemcitabine hydrochloride and pemetrexed disodium
Could I receive a placebo?
No, everyone receives an active treatment
How many people
68 participants
Where
41 sitesUnited States
Study dates
Jan 2004to Feb 2008
Phase
Phase 1/2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult
  • 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

Trial locations and contacts

41 sites in 1 country.

41 sites in 1 country

United States41 sites

  • AnMed Cancer Center

    Anderson, South Carolina, 29621

  • Fairview Ridges Hospital

    Burnsville, Minnesota, 55337

  • Cancer Center of Kansas, PA - Chanute

    Chanute, Kansas, 66720

  • Mercy and Unity Cancer Center at Mercy Hospital

    Coon Rapids, Minnesota, 55433

  • Cancer Center of Kansas, PA - Dodge City

    Dodge City, Kansas, 67801

  • Fairview Southdale Hospital

    Edina, Minnesota, 55435

  • Cancer Center of Kansas, PA - El Dorado

    El Dorado, Kansas, 67042

  • Green Bay Oncology, Limited - Escanaba

    Escanaba, Michigan, 49431

  • Mercy and Unity Cancer Center at Unity Hospital

    Fridley, Minnesota, 55432

  • Green Bay Oncology, Limited at St. Vincent Hospital Regional Cancer Center

    Green Bay, Wisconsin, 54301-3526

  • Green Bay Oncology, Limited at St. Mary's Hospital

    Green Bay, Wisconsin, 54303

  • St. Mary's Hospital Medical Center - Green Bay

    Green Bay, Wisconsin, 54303

  • St. Vincent Hospital Regional Cancer Center

    Green Bay, Wisconsin, 54307-3508

  • Dickinson County Healthcare System

    Iron Mountain, Michigan, 49801

  • Cancer Center of Kansas, PA - Kingman

    Kingman, Kansas, 67068

  • Southwest Medical Center

    Liberal, Kansas, 67901

  • Minnesota Oncology Hematology, PA - Maplewood

    Maplewood, Minnesota, 55109

  • Bay Area Cancer Care Center at Bay Area Medical Center

    Marinette, Wisconsin, 54143

  • Virginia Piper Cancer Institute at Abbott - Northwestern Hospital

    Minneapolis, Minnesota, 55407

  • Cancer Center of Kansas, PA - Newton

    Newton, Kansas, 67114

  • Green Bay Oncology, Limited - Oconto Falls

    Oconto Falls, Wisconsin, 54154

  • Cancer Center of Kansas, PA - Parsons

    Parsons, Kansas, 67357

  • Cancer Center of Kansas, PA - Pratt

    Pratt, Kansas, 67124

  • Hubert H. Humphrey Cancer Center at North Memorial Outpatient Center

    Robbinsdale, Minnesota, 55422-2900

  • Rutherford Hospital

    Rutherfordton, North Carolina, 28139

  • CCOP - Metro-Minnesota

    Saint Louis Park, Minnesota, 55416

  • Park Nicollet Cancer Center

    Saint Louis Park, Minnesota, 55416

  • United Hospital

    Saint Paul, Minnesota, 55102

  • Cancer Center of Kansas, PA - Salina

    Salina, Kansas, 67042

  • CCOP - Upstate Carolina

    Spartanburg, South Carolina, 29303

  • Gibbs Regional Cancer Center at Spartanburg Regional Medical Center

    Spartanburg, South Carolina, 29303

  • Green Bay Oncology, Limited - Sturgeon Bay

    Sturgeon Bay, Wisconsin, 54235

  • Ridgeview Medical Center

    Waconia, Minnesota, 55387

  • Cancer Center of Kansas, PA - Wellington

    Wellington, Kansas, 67152

  • Associates in Womens Health, PA - North Review

    Wichita, Kansas, 67203

  • Cancer Center of Kansas, PA - Medical Arts Tower

    Wichita, Kansas, 67208

  • Cancer Center of Kansas, PA - Wichita

    Wichita, Kansas, 67214

  • CCOP - Wichita

    Wichita, Kansas, 67214

  • Via Christi Cancer Center at Via Christi Regional Medical Center

    Wichita, Kansas, 67214

  • Cancer Center of Kansas, PA - Winfield

    Winfield, Kansas, 67156

  • Minnesota Oncology Hematology, PA - Woodbury

    Woodbury, Minnesota, 55125

Other trials in United States

About this study

Official title: 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.

Read the 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.

Being tested
gemcitabine hydrochloride, pemetrexed disodium
Keywords
advanced adult primary liver cancer, unresectable gallbladder cancer, unresectable extrahepatic bile duct cancer, adult primary cholangiocellular carcinoma
Medical subject headings
Bile Duct Neoplasms, Gallbladder Neoplasms, Liver Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT00059865
Study groupRoleWhat they receive
pemetrexed + gemcitabineExperimentalPhase 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.
Receives: Drug: gemcitabine hydrochloride; Drug: pemetrexed disodium

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Survival after 6 months of treatment

    Measured: Up to 6 months

Secondary outcomes (2)

  1. Response as assessed by RECIST criteria every 8-16 weeks

    Measured: Up to 16 weeks

  2. Toxicity as assessed by CTC v3 every 4 weeks

    Measured: Up to 4 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 May 2003 (estimated)
  2. Study startJan 2004
  3. Primary completionFeb 2007
  4. Study completionFeb 2008

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
68 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00059865
Sponsor's protocol ID
N9943
Other IDs
NCCTG-N9943, CDR0000298862, NCI-2012-02530
Status last verified
Dec 2016
First submitted
6 May 2003
Last updated
7 Dec 2016
Results posted
No
Data monitoring committee
No

Publications

  • Alberts SR, Foster NR, McWilliams RR, et al.: NCCTG phase I/II trial (N9943) of gemcitabine and pemetrexed in patients with unresectable or metastatic biliary tract carcinoma and gallbladder carcinoma: interim results. [Abstract] American Society of Clinical Oncology 2007 Gastrointestinal Cancers Symposium, 19 -21 January 2007, Orlando, Florida A-149, 2007.

  • Alberts SR, Sande JR, Foster NR, Quevedo FJ, McWilliams RR, Kugler JW, Fitch TR, Jaslowski AJ. Pemetrexed and gemcitabine for biliary tract and gallbladder carcinomas: a North Central Cancer Treatment Group (NCCTG) phase I and II Trial, N9943. J Gastrointest Cancer. 2007;38(2-4):87-94. doi: 10.1007/s12029-008-9037-8. Epub 2008 Nov 21.

    PubMed 19023677

  • McWilliams RR, Foster NR, Quevedo FJ, et al.: NCCTG phase I/II trial (N9943) of gemcitabine and pemetrexed in patients with biliary tract or gallbladder carcinoma: phase II results. [Abstract] J Clin Oncol 25 (Suppl 18): A-4578, 2007.

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing gemcitabine hydrochloride and pemetrexed disodium in people with Extrahepatic Bile Duct Cancer and Gallbladder Cancer, run by Alliance for Clinical Trials in Oncology at 41 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 7 Dec 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 41 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Survival after 6 months of treatment (time frame: Up to 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00059865, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Dec 2016.

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