Capecitabine, Docetaxel and Gemcitabine in Patients With Advanced Pancreas Cancer

Pancreatic Cancer Clinical Trial

Official title:

A Dose Escalating (Phase I) Study Looking at the Biomodulation of Capecitabine by Docetaxel and Gemcitabine in Patients With Advanced Pancreas Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00320749
• Other study ID #: OSU-05058
• Status: Completed
• Phase: Phase 1
• First received: April 28, 2006
• Last updated: September 15, 2015
• Start date: December 2005
• Est. completion date: January 2011

Study information

• Verified date: September 2015
• Source: Ohio State University Comprehensive Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

The primary purpose of this study is to define the maximum tolerated dose of combination docetaxel, gemcitabine, and capecitabine in patients with pancreatic cancer. Adverse effects will be measured in study participants. In addition, researchers will assess data about preliminary efficacy in patients with this treatment approach.

Description:

Rationale: Single agent gemcitabine is considered standard care for patients with advanced pancreatic cancer. However, better treatments offering improved outcomes are needed for people with this disease. The combination of docetaxel and capecitabine has shown significant and broad clinical activity in a variety of tumors. Laboratory research on the combination of capecitabine, docetaxel, and gemcitabine indicates synergistic action against tumor cells. The current study will test this combination in patients. The drug administration schedule in this study is aimed at maximizing the potential of activation of capecitabine by both docetaxel and gemcitabine.

Treatment: Study participants will be given docetaxel, gemcitabine, and capecitabine. All study drugs will be administered through intravenous infusions in three week cycles. Docetaxel will be given on days 1 and 8, gemcitabine on days 8 and 15, and capecitabine on days 8 through 21. This schedule will be followed by 1 week of rest without administration of study drugs. Since the primary goal of this study is to identify the maximum tolerated dose of the study drugs in combination, patients who enroll in the beginning of the study will receive lower amounts of the study drugs compared to patients who enroll later in the study. Several tests and exams will be given throughout the study to closely monitor patients.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 21
• Est. completion date: January 2011
• Est. primary completion date: October 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• adenocarcinoma of the pancreas

• no prior chemo except adjuvant

• ECOG PS 0-1

• peripheral neuropathy </= Gr. 1

Exclusion Criteria:

• Pregnant/lactating females

• Uncontrolled heart disease, diabetes, psychiatric disorder

• Therapeutic doses of Warfarin

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Pancreatic Cancer
• Pancreatic Neoplasms

Intervention

Drug:
• Capecitabine
Will be give on days 8-21
• Docetaxel
Will be given on days 1 and 8,
• Gemcitabine
A fixed dose rate will be give on days 8 and 15.

Locations

Country	Name	City	State
United States	The University of Michigan Comprehensive Cancer Center	Ann Arbor	Michigan
United States	Ohio State University	Columbus	Ohio

Sponsors (2)

Lead Sponsor	Collaborator
Tony Bekaii-Saab	University of Michigan Cancer Center

Country where clinical trial is conducted

United States, 

References & Publications (1)

Hill ME, Li X, Kim S, Campbell A, Culler K, Bloomston M, Zalupski M, Hejna G, Bekaii-Saab T. A phase I study of the biomodulation of capecitabine by docetaxel and gemcitabine (mGTX) in previously untreated patients with metastatic adenocarcinoma of the pa — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maximum Tolerated Dose		Weekly	Yes
Secondary	Common Toxicities	The NCI Common Terminology Criteria for Adverse Events version 3.0 was used for adverse event reporting and toxicity grading.	Weekly	Yes
Secondary	Therapeutic Response	Radiological assessment was done every 8 weeks and repsonses were measured according to the RECIST criteria.	Prior to cycle 3 and then every 2 cycles thereafter	No

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