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Phase 2 N=69 Treatment

Gemcitabine, Docetaxel, and Cetuximab in Patients With Unresectable Advanced Non-Small Cell Lung Cancer

Lung Cancer

Enrolled (actual)
69
Serious AEs
62.3%
Results posted
Nov 2012
Primary outcome: Primary: Overall Clinical Response Rate — 17 Percentage of participants

Study Design & Population

Study type
Interventional
Phase
Phase 2
Interventions
Gemcitabine (Drug); Docetaxel (Drug); Cetuximab (Drug)
Age
Adult, Older Adult · 18+ yrs
Sex
All
Sponsor
SCRI Development Innovations, LLC
Primary completion
Feb 2009

Outcome Measures

OutcomeResultp-value
PRIMARY
Overall Clinical Response Rate
17
SECONDARY
Progression Free Survival (PFS)
4.0
SECONDARY
Response Duration
7.0

Summary

This purpose of this study is to evaluate the role of gemcitabine and docetaxel, a well tolerated chemotherapy regimen in the treatment of advanced non-small cell lung cancer (NSCLC), in combination with a novel agent cetuximab.

Eligibility Criteria

Inclusion Criteria

To be included in the study, you must meet the following criteria:

  • 18 years of age or older
  • Non-small cell lung cancer confirmed by biopsy
  • Unresectable stage III or IV disease
  • Measurable disease
  • Must not have received any prior chemotherapy for lung cancer
  • Able to perform activities of daily living without considerable assistance
  • Adequate bone marrow, kidney, and liver function
  • Signed informed consent

Exclusion Criteria

You cannot participate in the study if any of the following apply to you:

  • History of serious heart disease within six months prior to study entry
  • Prior treatment with agents that target the EGFR pathway
  • History of any other uncontrolled or significant disease

Please note: There are additional inclusion/exclusion criteria. The study center will determine if you meet all of the criteria. If you do not qualify for the trial, study personnel will explain the reasons. If you do qualify, study personnel will explain the trial in detail and answer any questions you may have. You can then decide if you wish to participate.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00193453). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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