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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

Brief Summary:
This study will determine the objective response rate in chemotherapy naive non-small cell lung cancer patients with advanced disease.

Condition or disease Intervention/treatment Phase
Lung Cancer Non-Small-Cell Lung Carcinoma Drug: Capecitabine Drug: Docetaxel Phase 2

Detailed Description:

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 29 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase II Study of Capecitabine and Docetaxel in Previously Untreated Advanced Non-Small Cell Lung Cancer Patients
Study Start Date : December 2004
Actual Primary Completion Date : December 2012
Actual Study Completion Date : April 2013

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Docetaxel and Capecitabine 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

Primary Outcome Measures :
  1. 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.

Secondary Outcome Measures :
  1. Time to Tumor Progression [ Time Frame: Every 35 days ]
  2. One Year Survival [ Time Frame: one year ]
  3. Pharmacokinetics [ Time Frame: Cycle 2 ]

Information from the National Library of Medicine

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, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00201825

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United States, Ohio
Ohio State University
Columbus, Ohio, United States, 43210
Sponsors and Collaborators
Tony Bekaii-Saab
Roche Pharma AG
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Principal Investigator: Tony Bekaii-Saab Ohio State University
Additional Information:
Publications of Results:
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Responsible Party: Tony Bekaii-Saab, Principal Investigator, Ohio State University Comprehensive Cancer Center Identifier: NCT00201825    
Other Study ID Numbers: OSU-0356
NCI-2011-03593 ( Registry Identifier: CTRP (Clinical Trials Reporting Program) )
First Posted: September 20, 2005    Key Record Dates
Results First Posted: October 6, 2014
Last Update Posted: October 6, 2014
Last Verified: October 2014
Keywords provided by Tony Bekaii-Saab, Ohio State University Comprehensive Cancer Center:
Previously Untreated
Additional relevant MeSH terms:
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Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antimetabolites, Antineoplastic