Clinical trial · Interventional
A Trial of Gemcitabine, Infusional 5-Fluorouracil and Cisplatin for Advanced Pancreatic and Biliary Cancers
- 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)
Multi-agent chemotherapy has value for patients with advanced pancreatic-biliary cancers leading to responses in a substantial minority and increasing survival. The use of the FOLFIRINOX regimen is limited by its' intensity and toxicity. Previous protocol and clinical experience within the University of Michigan Pancreatic Program leads to an expectation of tolerance and efficacy of the proposed regimen. Advantages of the proposed regimen relative to FOLFIRINOX include: 1. Substitution of gemcitabine for irinotecan. Single agent activity of gemcitabine is at least as good as irinotecan (probably better, especially when delivered by FDR \[fixed-dose rate\] infusion) and gemcitabine is much better tolerated with less diarrhea, nausea/emesis, myelosuppression and alopecia. 2. Deletion of leucovorin infusion and 5FU bolus injection will lessen myelosuppression, mucositis and diarrhea. 3. Substitution of cisplatin for oxaliplatin will reduce cost of therapy and avoid cold aggravated dysesthesia. Presuming evidence of efficacy and confirmation of tolerance with the proposed regimen, the investigators believe this treatment may be more widely applicable to pancreatic-biliary cancer patients, including those with advanced disease as well as being considered for use in locally advanced and neo- and adjuvant settings.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Biliary Cancer | — | UNRESOLVED | — |
| Pancreatic Cancer | Malignant Pancreatic Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 5-FU | Drug | Fluorouracil | ALIAS |
| Cisplatin | Drug | Cisplatin | ALIAS |
| Gemcitabine | Drug | Gemcitabine | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Gemcitabine, 5-FU and Cisplatin
- description
- 4 cycles - Gemcitabine, 5-FU and Cisplatin (2 months)-Continue treatment until progression of disease or intolerable toxicity
- interventionNames
- Drug: Gemcitabine
- Drug: 5-FU
- Drug: Cisplatin
Primary outcomes (1)
- measure
- The Percentage of Untreated and Previously Treated Patients That Had a Partial Response to Treatment
- timeFrame
- 28 days
- description
- The primary objective of this clinical trial is to estimate the response rate to treatment with the triplet chemotherapy regimen of gemcitabine, infusional 5-FU, and cisplatin, in untreated and previously treated advanced pancreatic and biliary cancer patients. Partial Response (PR) is defined as At least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters.
Secondary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Patients must have histologic or cytologic diagnosis of pancreatic adenocarcinoma or biliary tract cancer (intrahepatic or extrahepatic cholangiocarcinoma or gallbladder carcinoma). * Patients must have clinical/radiologic evidence of metastatic disease. * Previous systemic therapy for metastatic disease limited to one cytotoxic chemotherapy regimen not containing cisplatin. Previous therapy for metastatic disease might have included gemcitabine or infusional 5-FU but not both agents. * ECOG (Eastern Cooperative Oncology Group) performance status \< 1 (A measure of quality of life where 0 represents asymptomatic and 5 represents death). * Patients must have adequate bone marrow (absolute neutrophil count \>1,500/mm3, platelet count \>100,000/mm3) and renal function (serum creatinine \< 1.25 x ULN). * Patients must have at least one measurable lesion per RECIST criteria. * Patients must be free of serious concomitant medical disorders incompatible with study participation including active infection requiring systemic therapy. * Previous malignancies are permitted provided that they have been treated with curative intent and patient is without evidence of active systemic disease. * Patients must be informed of the investigational nature of this study and provide written informed consent prior to receiving protocol treatment. Exclusion Criteria: * Patients with pre-existing peripheral neuropathy \> grade 2 are ineligible. * Previous systemic therapy for metastatic disease limited to one cytotoxic chemotherapy regimen not containing cisplatin. * Previous therapy for metastatic disease might have included gemcitabine or infusional 5-FU but not both agents. * Serious concomitant medical disorders incompatible with study participation including active infection requiring systemic therapy.
References
Publications (1)
- BACKGROUNDColucci et al., 2002, Louvet et al., 2005, Berlin et al., 2002, Cunningham et al., 2009, Heinemann et al., 2008, Valle et al., 2010