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

April 28, 2006
November 8, 2013
December 2005
October 2008   (final data collection date for primary outcome measure)
Maximum tolerated dose [ Time Frame: Weekly ] [ Designated as safety issue: Yes ]
Maximum tolerated dose
Complete list of historical versions of study NCT00320749 on ClinicalTrials.gov Archive Site
  • 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 ]
  • Toxicity
  • Therapeutic response
Not Provided
Not Provided
 
Capecitabine, Docetaxel and Gemcitabine in Patients With Advanced Pancreas Cancer
A Dose Escalating (Phase I) Study Looking at the Biomodulation of Capecitabine by Docetaxel and Gemcitabine in Patients With Advanced Pancreas Cancer

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.

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.

Interventional
Phase 1
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Pancreatic Cancer
  • 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 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
    Interventions:
    • Drug: Capecitabine
    • Drug: Docetaxel
    • Drug: Gemcitabine
  • 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
    Interventions:
    • Drug: Capecitabine
    • Drug: Docetaxel
    • Drug: Gemcitabine
  • 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
    Interventions:
    • Drug: Capecitabine
    • Drug: Docetaxel
    • Drug: Gemcitabine
  • 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
    Interventions:
    • Drug: Capecitabine
    • Drug: Docetaxel
    • Drug: Gemcitabine
  • 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
    Interventions:
    • Drug: Capecitabine
    • Drug: Docetaxel
    • Drug: Gemcitabine
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 pancreas. Cancer Chemother Pharmacol. 2011 Mar;67(3):511-7. doi: 10.1007/s00280-010-1348-3. Epub 2010 May 12.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
22
January 2011
October 2008   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00320749
OSU-05058
Yes
Tony Bekaii-Saab, Ohio State University Comprehensive Cancer Center
Tony Bekaii-Saab
Not Provided
Principal Investigator: Tanios Saab Ohio State University
Principal Investigator: Tanios Saab, M.D. Ohio State University
Ohio State University Comprehensive Cancer Center
November 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP