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

Lung Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00201825
• Other study ID #: OSU-0356
• Secondary ID: NCI-2011-03593
• Status: Completed
• Phase: Phase 2
• First received: September 12, 2005
• Last updated: October 1, 2014
• Start date: December 2004
• Est. completion date: April 2013

Study information

• Verified date: October 2014
• Source: Ohio State University Comprehensive Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 29
• Est. completion date: April 2013
• Est. primary completion date: December 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

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

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Cancer
• Lung Neoplasms
• Non-Small-Cell Lung Carcinoma

Intervention

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.
• Docetaxel
36 mg/m2 IV weekly for 3 weeks every 4 weeks.

Locations

Country	Name	City	State
United States	Ohio State University	Columbus	Ohio

Sponsors (2)

Lead Sponsor	Collaborator
Tony Bekaii-Saab	Roche Pharma AG

Country where clinical trial is conducted

United States, 

References & Publications (1)

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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Determine Objective Response Rate	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.	Every 35 days	No
Secondary	Time to Tumor Progression		Every 35 days	No
Secondary	One Year Survival		one year	No
Secondary	Pharmacokinetics		Cycle 2	No

External Links

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