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

This study has been completed.
Sponsor:
Collaborator:
Roche Pharma AG
Information provided by (Responsible Party):
Tony Bekaii-Saab, Ohio State University Comprehensive Cancer Center
ClinicalTrials.gov Identifier:
NCT00201825
First received: September 12, 2005
Last updated: October 1, 2014
Last verified: October 2014
  Purpose

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


Condition Intervention Phase
Lung Cancer
Non-Small-Cell Lung Carcinoma
Drug: Capecitabine
Drug: Docetaxel
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Ohio State University Comprehensive Cancer Center:

Primary Outcome Measures:
  • Determine Objective Response Rate [ Time Frame: Every 35 days ] [ Designated as safety issue: No ]
    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:
  • Time to Tumor Progression [ Time Frame: Every 35 days ] [ Designated as safety issue: No ]
  • One Year Survival [ Time Frame: one year ] [ Designated as safety issue: No ]
  • Pharmacokinetics [ Time Frame: Cycle 2 ] [ Designated as safety issue: No ]

Enrollment: 29
Study Start Date: December 2004
Study Completion Date: April 2013
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00201825

Locations
United States, Ohio
Ohio State University
Columbus, Ohio, United States, 43210
Sponsors and Collaborators
Tony Bekaii-Saab
Roche Pharma AG
Investigators
Principal Investigator: Tony Bekaii-Saab Ohio State University
  More Information

Additional Information:
Publications:
Responsible Party: Tony Bekaii-Saab, Principal Investigator, Ohio State University Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT00201825     History of Changes
Other Study ID Numbers: OSU-0356, NCI-2011-03593
Study First Received: September 12, 2005
Results First Received: September 25, 2014
Last Updated: October 1, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Ohio State University Comprehensive Cancer Center:
Previously Untreated
Advanced

Additional relevant MeSH terms:
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Docetaxel
Capecitabine
Fluorouracil
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antimetabolites, Antineoplastic
Antimetabolites
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on October 19, 2014