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

Phase 2
18 Years
Open (Enrolling)
Lung Cancer, Non-Small-Cell Lung Carcinoma

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Trial Information

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

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.

Inclusion Criteria:

- Must have advanced NSCLC

- No prior chemotherapy

- 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 >

Type of Study:


Study Design:

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Determine objective response rate

Outcome Time Frame:

Every 35 days

Safety Issue:


Principal Investigator

Tony Bekaii-Saab

Investigator Role:

Principal Investigator

Investigator Affiliation:

Ohio State University


United States: Food and Drug Administration

Study ID:




Start Date:

December 2004

Completion Date:

December 2012

Related Keywords:

  • Lung Cancer
  • Non-Small-Cell Lung Carcinoma
  • Previously Untreated
  • Advanced
  • Carcinoma
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms



Ohio State University Columbus, Ohio  43210