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Phase 2 Completed N=69 Treatment

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

Source: ClinicalTrials.gov NCT00193453 ↗
Enrolled (actual)
69
Serious AEs
62.3%
Results posted
Nov 2012
Primary outcomePrimary: Overall Clinical Response Rate — 17 Percentage of participants

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.

Outcome Measures

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

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. Informational only — not medical advice.

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