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

NCT00059865 | Completed Phase 1

• 4 other identifiers: N9943NCCTG-N9943CDR0000298862NCI-2012-02530
• Study Type: interventional
• Target: 68
• Locations: 1 country
• Sites: 41

Brief 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. 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.

Conditions

Extrahepatic Bile Duct Cancer; Gallbladder Cancer; Liver Cancer

Keywords

advanced adult primary liver cancer; unresectable gallbladder cancer; unresectable extrahepatic bile duct cancer; adult primary cholangiocellular carcinoma

Outcome Measures

Primary Outcomes (1)

• Survival after 6 months of treatment

  Up to 6 months

Secondary Outcomes (2)

• Response as assessed by RECIST criteria every 8-16 weeks

  Up to 16 weeks

• Toxicity as assessed by CTC v3 every 4 weeks

  Up to 4 weeks

Study Arms (1)

pemetrexed + gemcitabine

EXPERIMENTAL

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

Interventions

gemcitabine hydrochloride DRUG

pemetrexed + gemcitabine

pemetrexed disodium DRUG

pemetrexed + gemcitabine

Eligibility Criteria

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

* 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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Alliance for Clinical Trials in Oncology: lead
• National Cancer Institute (NCI): collaborator

Study Sites (41)

Cancer Center of Kansas, PA - Chanute

Chanute, Kansas, 66720, United States

Location

Cancer Center of Kansas, PA - Dodge City

Dodge City, Kansas, 67801, United States

Location

Cancer Center of Kansas, PA - El Dorado

El Dorado, Kansas, 67042, United States

Location

Cancer Center of Kansas, PA - Kingman

Kingman, Kansas, 67068, United States

Location

Southwest Medical Center

Liberal, Kansas, 67901, United States

Location

Cancer Center of Kansas, PA - Newton

Newton, Kansas, 67114, United States

Location

Cancer Center of Kansas, PA - Parsons

Parsons, Kansas, 67357, United States

Location

Cancer Center of Kansas, PA - Pratt

Pratt, Kansas, 67124, United States

Location

Cancer Center of Kansas, PA - Salina

Salina, Kansas, 67042, United States

Location

Cancer Center of Kansas, PA - Wellington

Wellington, Kansas, 67152, United States

Location

Associates in Womens Health, PA - North Review

Wichita, Kansas, 67203, United States

Location

Cancer Center of Kansas, PA - Medical Arts Tower

Wichita, Kansas, 67208, United States

Location

Cancer Center of Kansas, PA - Wichita

Wichita, Kansas, 67214, United States

Location

CCOP - Wichita

Wichita, Kansas, 67214, United States

Location

Via Christi Cancer Center at Via Christi Regional Medical Center

Wichita, Kansas, 67214, United States

Location

Cancer Center of Kansas, PA - Winfield

Winfield, Kansas, 67156, United States

Location

Green Bay Oncology, Limited - Escanaba

Escanaba, Michigan, 49431, United States

Location

Dickinson County Healthcare System

Iron Mountain, Michigan, 49801, United States

Location

Fairview Ridges Hospital

Burnsville, Minnesota, 55337, United States

Location

Mercy and Unity Cancer Center at Mercy Hospital

Coon Rapids, Minnesota, 55433, United States

Location

Fairview Southdale Hospital

Edina, Minnesota, 55435, United States

Location

Mercy and Unity Cancer Center at Unity Hospital

Fridley, Minnesota, 55432, United States

Location

Minnesota Oncology Hematology, PA - Maplewood

Maplewood, Minnesota, 55109, United States

Location

Virginia Piper Cancer Institute at Abbott - Northwestern Hospital

Minneapolis, Minnesota, 55407, United States

Location

Hubert H. Humphrey Cancer Center at North Memorial Outpatient Center

Robbinsdale, Minnesota, 55422-2900, United States

Location

CCOP - Metro-Minnesota

Saint Louis Park, Minnesota, 55416, United States

Location

Park Nicollet Cancer Center

Saint Louis Park, Minnesota, 55416, United States

Location

United Hospital

Saint Paul, Minnesota, 55102, United States

Location

Ridgeview Medical Center

Waconia, Minnesota, 55387, United States

Location

Minnesota Oncology Hematology, PA - Woodbury

Woodbury, Minnesota, 55125, United States

Location

Rutherford Hospital

Rutherfordton, North Carolina, 28139, United States

Location

AnMed Cancer Center

Anderson, South Carolina, 29621, United States

Location

CCOP - Upstate Carolina

Spartanburg, South Carolina, 29303, United States

Location

Gibbs Regional Cancer Center at Spartanburg Regional Medical Center

Spartanburg, South Carolina, 29303, United States

Location

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

Green Bay, Wisconsin, 54301-3526, United States

Location

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

Green Bay, Wisconsin, 54303, United States

Location

St. Mary's Hospital Medical Center - Green Bay

Green Bay, Wisconsin, 54303, United States

Location

St. Vincent Hospital Regional Cancer Center

Green Bay, Wisconsin, 54307-3508, United States

Location

Bay Area Cancer Care Center at Bay Area Medical Center

Marinette, Wisconsin, 54143, United States

Location

Green Bay Oncology, Limited - Oconto Falls

Oconto Falls, Wisconsin, 54154, United States

Location

Green Bay Oncology, Limited - Sturgeon Bay

Sturgeon Bay, Wisconsin, 54235, United States

Location

Related Publications (3)

• 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.

  RESULT

• 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.

  PMID: 19023677 RESULT

• 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.

  RESULT

MeSH Terms

Conditions

Bile Duct Neoplasms; Gallbladder Neoplasms; Liver Neoplasms

Interventions

Gemcitabine; Pemetrexed

Condition Hierarchy (Ancestors)

Biliary Tract Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Bile Duct Diseases; Biliary Tract Diseases; Digestive System Diseases; Gallbladder Diseases; Liver Diseases

Intervention Hierarchy (Ancestors)

Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Guanine; Hypoxanthines; Purinones; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Glutamates; Amino Acids, Acidic; Amino Acids; Amino Acids, Peptides, and Proteins; Amino Acids, Dicarboxylic

Study Officials

• Steven R. Alberts, MD

  Mayo Clinic

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 6, 2003
• First Posted: May 7, 2003
• Study Start: January 1, 2004
• Primary Completion: February 1, 2007
• Study Completion: February 1, 2008
• Last Updated: December 7, 2016

Record last verified: 2016-12

Locations

US (41)