A Trial of Gemcitabine, Infusional 5-Fluorouracil and Cisplatin for Advanced Pancreatic and Biliary Cancers

NCT01661114 | Completed Phase 2 Results DMC

• 2 other identifiers: UMCC 2011.036HUM 49518
• Study Type: interventional
• Target: 39
• Locations: 1 country
• Sites: 1

Brief Summary

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. 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. 2.Deletion of leucovorin infusion and 5FU bolus injection will lessen myelosuppression, mucositis and diarrhea.
3. 3.Substitution of cisplatin for oxaliplatin will reduce cost of therapy and avoid cold aggravated dysesthesia.

Conditions

Pancreatic Cancer; Biliary Cancer

Keywords

Gemcitabine, Infusional 5-Fluorouracil,Cisplatin; Advanced Pancreatic and Biliary Cancers; untreated & previously treated pancreatic & biliary cancer.

Outcome Measures

Primary Outcomes (1)

• The Percentage of Untreated and Previously Treated Patients That Had a Partial Response to Treatment

  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.

  28 days

Secondary Outcomes (1)

• Median Overall Survival of Previously Treated and Previously Untreated Patients

  1 year

Study Arms (1)

Gemcitabine, 5-FU and Cisplatin

EXPERIMENTAL

4 cycles - Gemcitabine, 5-FU and Cisplatin (2 months)-Continue treatment until progression of disease or intolerable toxicity

Drug: Gemcitabine; Drug: 5-FU; Drug: Cisplatin

Interventions

Gemcitabine DRUG

Gemcitabine, 5-FU and Cisplatin

5-FU DRUG

Also known as: 5-Fluorouracil

Gemcitabine, 5-FU and Cisplatin

Cisplatin DRUG

Gemcitabine, 5-FU and Cisplatin

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Michigan Rogel Cancer Center: lead

Study Sites (1)

University of Michigan Comprehensive Cancer Center

Ann Arbor, Michigan, 48109, United States

Location

Related Publications (1)

• Colucci et al., 2002, Louvet et al., 2005, Berlin et al., 2002, Cunningham et al., 2009, Heinemann et al., 2008, Valle et al., 2010

  BACKGROUND

MeSH Terms

Conditions

Pancreatic Neoplasms; Biliary Tract Neoplasms

Interventions

Gemcitabine; Fluorouracil; Cisplatin

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases; Biliary Tract Diseases

Intervention Hierarchy (Ancestors)

Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Uracil; Pyrimidinones; Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds

Results Point of Contact

• Title: Dr. Mark Zalupski, M.D.
• Organization: University of Michigan Comprehensive Cancer Center

zalupski@umich.edu

734-615-3969

Study Officials

• Mark Zalupski, MD

  University of Michigan Rogel Cancer Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 24, 2012
• First Posted: August 9, 2012
• Study Start: July 1, 2011
• Primary Completion: December 1, 2014
• Study Completion: March 1, 2016
• Last Updated: October 19, 2016
• Results First Posted: February 4, 2016

Record last verified: 2016-09

Locations

US (1)