A Phase II Study of Capecitabine and Docetaxel in Previously Untreated Advanced Non-Small Cell Lung Cancer Patients

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. Identifier: NCT00201825
Recruitment Status : Completed
First Posted : September 20, 2005
Results First Posted : October 6, 2014
Last Update Posted : October 6, 2014
Roche Pharma AG
Information provided by (Responsible Party):
Tony Bekaii-Saab, Ohio State University Comprehensive Cancer Center

September 12, 2005
September 20, 2005
September 25, 2014
October 6, 2014
October 6, 2014
December 2004
December 2012   (Final data collection date for primary outcome measure)
Determine Objective Response Rate [ Time Frame: Every 35 days ]
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.
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Complete list of historical versions of study NCT00201825 on Archive Site
  • Time to Tumor Progression [ Time Frame: Every 35 days ]
  • One Year Survival [ Time Frame: one year ]
  • Pharmacokinetics [ Time Frame: Cycle 2 ]
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A Phase II Study of Capecitabine and Docetaxel in Previously Untreated Advanced Non-Small Cell Lung Cancer Patients
A Phase II Study of Capecitabine and Docetaxel in Previously Untreated Advanced Non-Small Cell Lung Cancer Patients
This study will determine the objective response rate in chemotherapy naive non-small cell lung cancer patients with advanced disease.

Rationale: Docetaxel has some efficacy against non-small cell lung cancer (NSCLC). This drug is Food and Drug Administration approved in combination with cisplatin (Platinol) for the treatment of unresectable, locally advanced or metastatic NSCLC in patients who have not previously had chemotherapy for this condition. Docetaxel is also approved for second line treatment of metastatic NSCLC. Research indicates that capecitabine, in combination with docetaxel, has efficacy against NSCLC. Capecitabine appears to have anti-cancer activity through several enzymes. This drug is metabolized in the body to another agent called 5-FU. During this conversion process, 5-FU requires thymidine phosphorylase (TP), a cellular characteristic associated with tumor growth. There are higher levels of TP expression in tumors as compared to normal tissue. The drug administration schedule in this study is designed to optimize efficacy against the TP target through both docetaxel and capecitabine. This study will measure biological changes to TP and other enzymes to help researchers gain more information about how capecitabine and docetaxel works against NSCLC.

Purpose: This study will evaluate the efficacy of docetaxel and capecitabine in patients with previously untreated advanced NSCLC. Tests related to tumor biology will be conducted before and during study treatments and correlated with patient responses to therapies.

Treatment: Patients in this study will receive docetaxel and capecitabine. Docetaxel will be administered through intravenous infusions. Capecitabine will be provided through oral pills. A four-week period constitutes one cycle. Docetaxel will be given weekly for three weeks followed by one week of rest. Capecitabine will be taken twice daily on days 5 through 14 of the treatment cycle. Several tests and exams will be given throughout the study to closely monitor patients. Treatments will be discontinued due to disease growth or unacceptable side effects.

Phase 2
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
  • Lung Cancer
  • Non-Small-Cell Lung Carcinoma
  • Drug: Capecitabine
    1250 mg/m2/day in 2 oral daily divided doses of 625 mg/m2 on day 5 of every cycle and continued for 14 days.
    Other Name: Xeloda
  • Drug: Docetaxel
    36 mg/m2 IV weekly for 3 weeks every 4 weeks.
    Other Name: Taxotere
Experimental: Docetaxel and Capecitabine
  • Drug: Capecitabine
  • Drug: Docetaxel
Bertino EM, Bekaii-Saab T, Fernandez S, Diasio RB, Karim NA, Otterson GA, Villalona-Calero MA. A phase II study of modulated-capecitabine and docetaxel in chemonaive patients with advanced non-small cell lung cancer (NSCLC). Lung Cancer. 2013 Jan;79(1):27-32. doi: 10.1016/j.lungcan.2012.09.013. Epub 2012 Oct 16.

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
April 2013
December 2012   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Must have advanced NSCLC
  • No prior chemotherapy
  • Eastern Cooperative Oncology Group(ECOG)Performance Status:0 or 1
  • Must have measurable disease (RECIST criteria)
  • life expectancy of at least 12 weeks
  • adequate organ function including

Exclusion Criteria:

  • Pregnant or lactating women
  • Psychiatric disorders that would interfere w/consent or follow-up
  • Patients with uncontrolled diabetes mellitus, defined as random blood sugar > 250mg/dL.
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
United States
NCI-2011-03593 ( Registry Identifier: CTRP (Clinical Trials Reporting Program) )
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Tony Bekaii-Saab, Ohio State University Comprehensive Cancer Center
Tony Bekaii-Saab
Roche Pharma AG
Principal Investigator: Tony Bekaii-Saab Ohio State University
Ohio State University Comprehensive Cancer Center
October 2014

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