Clinical trial · Interventional
Gemcitabine Plus Pemetrexed Disodium in Treating Patients With Unresectable or Metastatic Biliary Tract or Gallbladder Cancer
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
NCT00059865CI-TRIAL-00025050completedPhase 1 / Phase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Extrahepatic Bile Duct Cancer | Malignant Extrahepatic Bile Duct Neoplasm | ALIAS | 0.90 |
| Gallbladder Cancer | Malignant Gallbladder Neoplasm | CURATED_EXACT | 0.92 |
| Liver Cancer | Malignant Liver Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| gemcitabine hydrochloride | Drug | Gemcitabine | ALIAS |
| pemetrexed disodium | Drug | Pemetrexed | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- pemetrexed + gemcitabine
- description
- 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.
- interventionNames
- Drug: gemcitabine hydrochloride
- Drug: pemetrexed disodium
Primary outcomes (1)
- measure
- Survival after 6 months of treatment
- timeFrame
- Up to 6 months
Secondary outcomes (2)
- measure
- Response as assessed by RECIST criteria every 8-16 weeks
- timeFrame
- Up to 16 weeks
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
* 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
References
Publications (3)
- RESULTAlberts 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.
- RESULTAlberts 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
- RESULTMcWilliams 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.