Clinical trial NCT00201825: A Phase II Study of Capecitabine and Docetaxel in Previously Untreated Advanced Non-Small Cell Lung Cancer Patients
Official title: A Phase II Study of Capecitabine and Docetaxel in Previously Untreated Advanced Non-Small Cell Lung Cancer Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Lung Cancer
Non-Small-Cell Lung Carcinoma
Keywords: Previously Untreated
Advanced
Lead sponsor: Ohio State University Comprehensive Cancer Center
Sponsor class: OTHER
Collaborators: name: Roche Pharma AG
First posted: 2005-09-20
Enrollment: 29
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Determine Objective Response Rate
timeFrame: Every 35 days
Secondary outcomes:
measure: Time to Tumor Progression
timeFrame: Every 35 days
measure: One Year Survival
timeFrame: one year
measure: Pharmacokinetics
timeFrame: Cycle 2
Other outcomes:
Locations:
city: Columbus
country: United States
facility: Ohio State University
state: Ohio
Study officials:
affiliation: Ohio State University
name: Tony Bekaii-Saab
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.