Capecitabine, Docetaxel and Gemcitabine in Patients With Advanced Pancreas Cancer

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Tony Bekaii-Saab, Ohio State University Comprehensive Cancer Center
ClinicalTrials.gov Identifier:
NCT00320749
First received: April 28, 2006
Last updated: November 8, 2013
Last verified: November 2013
  Purpose

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.


Condition Intervention Phase
Pancreatic Cancer
Drug: Capecitabine
Drug: Docetaxel
Drug: Gemcitabine
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Dose Escalating (Phase I) Study Looking at the Biomodulation of Capecitabine by Docetaxel and Gemcitabine in Patients With Advanced Pancreas Cancer

Resource links provided by NLM:


Further study details as provided by Ohio State University Comprehensive Cancer Center:

Primary Outcome Measures:
  • Maximum tolerated dose [ Time Frame: Weekly ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Toxicity [ Time Frame: Weekly ] [ Designated as safety issue: Yes ]
  • Therapeutic response [ Time Frame: Prior to cycle 3 and then every 2 cycles thereafter ] [ Designated as safety issue: No ]

Enrollment: 22
Study Start Date: December 2005
Study Completion Date: January 2011
Primary Completion Date: October 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Dose Level -2
Docetaxel at 24 mg/m2 on days 1 and 8, Gemcitabine at 600 mg/m2 (over 60 minutes) on days 8 and 15 and capecitabine at 500 mg/m2/12 hours on days 8-21
Drug: Capecitabine
Will be give on days 8-21
Other Name: Xeloda
Drug: Docetaxel
Will be given on days 1 and 8,
Other Name: Taxotere
Drug: Gemcitabine
A fixed dose rate will be give on days 8 and 15.
Other Name: Gemzar
Experimental: Dose level -1
Docetaxel at 30 mg/m2 on days 1 and 8, Gemcitabine at 600 mg/m2 (over 60 minutes) on days 8 and 15 and capecitabine at 500 mg/m2/12 hours on days 8-21
Drug: Capecitabine
Will be give on days 8-21
Other Name: Xeloda
Drug: Docetaxel
Will be given on days 1 and 8,
Other Name: Taxotere
Drug: Gemcitabine
A fixed dose rate will be give on days 8 and 15.
Other Name: Gemzar
Experimental: Dose level 1
Docetaxel at 30 mg/m2 on days 1 and 8, Gemcitabine at 750 mg/m2 (over 75 minutes) on days 8 and 15 and capecitabine at 500 mg/m2/12 hours on days 8-21
Drug: Capecitabine
Will be give on days 8-21
Other Name: Xeloda
Drug: Docetaxel
Will be given on days 1 and 8,
Other Name: Taxotere
Drug: Gemcitabine
A fixed dose rate will be give on days 8 and 15.
Other Name: Gemzar
Experimental: Dose level 2
Docetaxel at 30 mg/m2 on days 1 and 8, Gemcitabine at 750 mg/m2 (over 75 minutes) on days 8 and 15 and capecitabine at 625 mg/m2/12 hours on days 8-21
Drug: Capecitabine
Will be give on days 8-21
Other Name: Xeloda
Drug: Docetaxel
Will be given on days 1 and 8,
Other Name: Taxotere
Drug: Gemcitabine
A fixed dose rate will be give on days 8 and 15.
Other Name: Gemzar
Experimental: Dose level 3
Docetaxel at 36 mg/m2 on days 1 and 8, Gemcitabine at 750 mg/m2 (over 75 minutes) on days 8 and 15 and capecitabine at 625 mg/m2/12 hours on days 8-21
Drug: Capecitabine
Will be give on days 8-21
Other Name: Xeloda
Drug: Docetaxel
Will be given on days 1 and 8,
Other Name: Taxotere
Drug: Gemcitabine
A fixed dose rate will be give on days 8 and 15.
Other Name: Gemzar

Detailed 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00320749

Locations
United States, Michigan
The University of Michigan Comprehensive Cancer Center
Ann Arbor, Michigan, United States, 48109
United States, Ohio
Ohio State University
Columbus, Ohio, United States, 43210
Sponsors and Collaborators
Tony Bekaii-Saab
Investigators
Principal Investigator: Tanios Saab Ohio State University
Principal Investigator: Tanios Saab, M.D. Ohio State University
  More Information

Additional Information:
Publications:
Responsible Party: Tony Bekaii-Saab, Principal Investigator, Ohio State University Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT00320749     History of Changes
Other Study ID Numbers: OSU-05058
Study First Received: April 28, 2006
Last Updated: November 8, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Ohio State University Comprehensive Cancer Center:
Advanced Pancreatic Cancer

Additional relevant MeSH terms:
Pancreatic Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases
Pancrelipase
Gemcitabine
Capecitabine
Fluorouracil
Docetaxel
Gastrointestinal Agents
Therapeutic Uses
Pharmacologic Actions
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Radiation-Sensitizing Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators

ClinicalTrials.gov processed this record on August 18, 2014