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A Study of Docetaxel in Combination With Capecitabine in Stomach and Esophagus Cancers
This study is ongoing, but not recruiting participants.
Sponsors and Collaborators: University of Pittsburgh
Aventis Pharmaceuticals
Hoffmann-La Roche
Information provided by: University of Pittsburgh
ClinicalTrials.gov Identifier: NCT00177255
  Purpose

This is a phase II study that will investigate weekly dosing of docetaxel in combination with capecitabine in advanced gastric and gastro-esophageal adenocarcinomas.


Condition Intervention Phase
Cancer
Drug: Docetaxel
Drug: Capecitabine
Phase II

MedlinePlus related topics: Cancer Esophagus Disorders
Drug Information available for: Docetaxel Capecitabine
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label, Active Control, Single Group Assignment, Safety/Efficacy Study
Official Title: A Phase II Study of Weekly Docetaxel (Taxotere®) in Combination With Capecitabine (Xeloda) in Advanced Gastric and Gastro-Esophageal Adenocarcinomas.

Further study details as provided by University of Pittsburgh:

Primary Outcome Measures:
  • median survival [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To determine response rate [ Time Frame: survival at 2 years ] [ Designated as safety issue: No ]

Enrollment: 43
Study Start Date: April 2005
Estimated Study Completion Date: December 2009
Estimated Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Docetaxel

    Docetaxel 30 mg/m2 will be administered as a 30-minute infusion on days 1 and 8. Each cycle will consist of 21 days.

    Cycle 2 will begin on day 22.

    Drug: Capecitabine

    Capecitabine 825 mg/m2 bid (total daily dose 1650 mg/m2) will be administered orally for 14 days (days 1-14).

    Each cycle will consist of 21 days.

    Cycle 2 will begin on day 22.

Detailed Description:

This is a phase II study that will investigate weekly dosing of docetaxel in combination with capecitabine in advanced gastric and gastro-esophageal adenocarcinomas. Docetaxel 30mg/m2 will be administered on days 1 and 8 of each cycle and capecitabine 825mg/m2 bid (total daily dose 1650mg/m2) will be administered orally for 14 days (days 1-14) of each cycle. Each cycle is 21 days. Subjects will receive unlimited cycles of docetaxel and capecitabine until there is evidence of disease progression or unacceptable side effects.

  Eligibility

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

Inclusion Criteria:

  1. Have histologically or cytologically confirmed locally advanced (unresectable) or metastatic adenocarcinoma of gastric, gastro-esophageal, or esophageal origin.
  2. Must have measurable or evaluable disease.
  3. Received adjuvant therapy are eligible if adjuvant therapy was given ≥ 6 months prior to the diagnosis of metastatic disease.
  4. Life expectancy greater than 12 weeks.
  5. ECOG performance status < 2.
  6. Adequate organ and marrow function.
  7. Preexisting peripheral neuropathy if present must be grade 0 or 1.
  8. Women and men of child-bearing potential must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of study participation, and for at least 3 months thereafter. Postmenopausal women must have been amenorrheic for at least 12 months to be considered of non-childbearing potential

Exclusion Criteria:

  1. No chemotherapy or radiotherapy within 4 weeks
  2. Not receiving any other investigational agents or participate in any investigational drug study within 4 weeks preceding the start of study treatment.
  3. Patients with known brain metastases shall be excluded from this clinical trial
  4. Patients with evidence or history of uncontrolled seizures, central nervous system disorders or psychiatric disability judged by the investigator to be clinically significant that precludes informed consent or interferes with the compliance of oral drug intake will also be excluded.
  5. History of severe hypersensitivity reaction to docetaxel or other drugs formulated with polysorbate 80.
  6. History of allergic reactions attributed to compounds of similar chemical or biologic composition to docetaxel, capecitabine or 5-FU.
  7. Uncontrolled intercurrent illness
  8. Pregnant or breast feeding women are excluded from this study
  9. Inability to swallow tablets or those who have malabsorptive symptoms will be excluded.
  10. HIV-positive patients receiving combination anti-retroviral therapy are excluded from the study because of possible pharmacokinetic interactions with docetaxel or capecitabine.
  11. Prior use of docetaxel or capecitabine is not allowed ( Prior 5FU therapy is allowed).
  12. Treatment for other carcinomas within the last five years, except cured non-melanoma skin and treated in-situ cervical cancer.
  13. Major surgery ( i.e laparotomy, line placement is not considered major surgery)within 4 weeks of the start of study treatment, without complete recovery.
  14. Known, existing uncontrolled coagulopathy.
  15. Patients on anticonvulsants that are metabolized via P450 3A4 pathway.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00177255

Locations
United States, Pennsylvania
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States, 15232
Sponsors and Collaborators
University of Pittsburgh
Aventis Pharmaceuticals
Hoffmann-La Roche
Investigators
Principal Investigator: Kenneth Foon, MD University of Pittsburgh
  More Information

Responsible Party: University of Pittsburgh Cancer Institute ( University of Pittsburgh Cancer Institute )
Study ID Numbers: 04-026
Study First Received: September 12, 2005
Last Updated: March 27, 2008
ClinicalTrials.gov Identifier: NCT00177255  
Health Authority: United States: Food and Drug Administration

Keywords provided by University of Pittsburgh:
gastric
stomach
esophagus
esophageal

Study placed in the following topic categories:
Docetaxel
Capecitabine
Esophageal disorder
Esophageal Diseases
Adenocarcinoma

Additional relevant MeSH terms:
Antimetabolites
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009