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Capecitabine, Docetaxel and Gemcitabine in Patients With Advanced Pancreas Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00320749
Recruitment Status : Completed
First Posted : May 3, 2006
Results First Posted : October 19, 2015
Last Update Posted : June 27, 2016
Information provided by (Responsible Party):

April 28, 2006
May 3, 2006
September 15, 2015
October 19, 2015
June 27, 2016
December 2005
October 2008   (Final data collection date for primary outcome measure)
Maximum Tolerated Dose (MTD) [ Time Frame: Weekly up to 24 weeks ]
MTD will be the dose at which 1 or fewer patients (≤ 1/6) experiences a DLT during the first or second cycle with the next higher dose having at least 2/3 or 2/6 patients experiencing Dose Limiting Toxicities (DLT).
Maximum Tolerated Dose
Complete list of historical versions of study NCT00320749 on ClinicalTrials.gov Archive Site
  • Common Toxicities [ Time Frame: Weekly up to 24 weeks ]
    The NCI Common Terminology Criteria for Adverse Events version 3.0 was used for adverse event reporting and toxicity grading.
  • Therapeutic Response [ Time Frame: every 8 weeks, up to 24 weeks ]
    Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.
  • 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.

Phase 1
Intervention Model: Single Group Assignment
Masking: None (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: capecitabine, docetaxel, gemcitabine
Dose escalation study of mGTX using three dose levels (DL1-3). Patients received docetaxel on days 1 and 8, gemcitabine on days 8 and 15, and capcitabine on days 8 through 21. Gemcitabine fixed dose at 750 mg/m2 over 75 min, capecitabine twice daily and escalated from 500 to 650 mg/m2 at DL2 and docetaxel increased from 30 to 36 mg/m2 at DL3.
  • 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.
January 2011
October 2008   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • adenocarcinoma of the pancreas
  • no prior chemo except adjuvant
  • Eastern Cooperative Oncology Group (ECOG) Performance Status 0-1
  • peripheral neuropathy </= Gr. 1

Exclusion Criteria:

  • Pregnant/lactating females
  • Uncontrolled heart disease, diabetes, psychiatric disorder
  • Therapeutic doses of Warfarin
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
United States
Not Provided
Not Provided
Tony Bekaii-Saab, Ohio State University Comprehensive Cancer Center
Tony Bekaii-Saab
University of Michigan Cancer Center
Principal Investigator: Tanios Saab Ohio State University
Principal Investigator: Tanios Saab, M.D. Ohio State University
Ohio State University Comprehensive Cancer Center
May 2016

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