Frailty Index and Geriatric Assessment in Predicting Toxicity to Front-Line Chemotherapy in Treating Patients With Stage IV Non-Small Cell Lung Cancer

This study is currently recruiting participants.
Verified on June 2011 by Wake Forest University

First Received on December 3, 2009.  
Last Updated on June 16, 2011  
History of Changes
This Clinical Trial Sponsored By: Wake Forest University
Collaborator: National Cancer Institute (NCI)
Information provided by: Wake Forest University
ClinicalTrials.gov Identifier: NCT01026467
 

Purpose for Clinical Trial

RATIONALE: A frailty index and geriatric assessment prior to treatment may help identify a better treatment regimen.

PURPOSE: This phase II trial is studying how well a frailty index and geriatric assessment works in predicting toxicity to front-line chemotherapy in treating patients with stage IV non-small cell lung cancer.

Condition Study Intervention Clinical Trial Phase
Non-small Cell Lung Cancer
Recurrent Non-small Cell Lung Cancer
Stage IV Non-small Cell Lung Cancer
Drug: cisplatin
Drug: carboplatin
Other: questionnaire administration
Phase II

Study Type: Study Interventional
Study Design: Study Intervention Model: Single Group Assignment
Masking: Open Label
Official Title: A Phase II Study of Fraility Index and Geriatric Assessment as Predictors of Toxicity to Front-Line Chemotherapy in Patients With Stage IV Non-Small Cell Lung Cancer

Resource links provided by NLM:

MedlinePlus related topics:
Cancer
Lung Cancer
Drug Information available for:
Cisplatin
Carboplatin

U.S. FDA Resources

Further study details as provided by Wake Forest University:

Primary Outcome Measures For Clinical Trial:

  • Use of the Frailty Index and/or the geriatric assessment in prediction of toxicity [ Time Frame: Prior to chemotherapy ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 100
Study Start Date: January 2010
Estimated Primary Completion Date: November 2012 (Final data collection date for primary outcome measure)

Arms

Assigned Study Interventions

Arm I: Experimental

Patients complete a frailty index and geriatric assessment prior to beginning chemotherapy. Patients receive standard-of-care chemotherapy comprising carboplatin IVand paclitaxel IV on day 1. Treatment repeats every 21 days for up to 2 courses
Study Interventions:
  • Drug: cisplatin
  • Drug: carboplatin
  • Other: questionnaire administration
Drug: cisplatin

Given IV
Other Names:
  • CACP
  • CDDP
  • CPDD
  • DDP
  • Neoplatin

Drug: carboplatin

Given IV
Other Names:
  • Carboplat
  • CBDCA
  • JM-8
  • Paraplat
  • Paraplatin
  • Paraplatine

Other: questionnaire administration

Detailed Description:

PRIMARY OBJECTIVE:

I. To determine the correlation of the data from the frailty index and geriatric assessment tool with the level of toxicity encountered in the first two cycles of therapy.

OUTLINE: Patients complete a frailty index and geriatric assessment prior to beginning chemotherapy. Patients receive standard-of-care chemotherapy comprising carboplatin IVand paclitaxel IV on day 1. Treatment repeats every 21 days for up to 2 courses.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Pathological documentation of stage IV non-small cell lung cancer
  • Patients with brain metastases are allowed on protocol only if they have received brain irradiation and are neurologically stable
  • Prior adjuvant chemotherapy for the earlier stages of non-small cell lung cancer is allowed
  • Patients with other malignancies are allowed on protocol unless they are receiving active treatment (surgery, radiation, chemotherapy or immunotherapy) for the other malignancy
  • Ability to understand and the willingness to sign a written informed consent document

Exclusion Criteria:

  • Prior radiation therapy other than brain irradiation for brain metastases
  • Pregnant and/or lactating women
  • Prior palliative chemotherapy
  • No prophylactic use of any granulocyte colony stimulating factor ( such as pegfilgrastim) in cycle 1
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01026467

Locations
United States, North Carolina
Wake Forest University Health Sciences Recruiting
Winston-Salem, North Carolina, United States, 27157
Contact: Heidi Di Klepin     336-716-7975     hklepin@wfubmc.edu    
Principal Investigator: Heidi Di Klepin            
Sponsors and Collaborators
Wake Forest University
National Cancer Institute (NCI)
Investigators
Principal Investigator: Heidi Klepin Wake Forest University
  More Information

No publications provided

Responsible Party: Klepin, Heidi, Wake Forest University Health Sciences
ClinicalTrials.gov Identifier:

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