| October 21, 2009 |
| November 13, 2009 |
| June 2001 |
| January 2002 (final data collection date for primary outcome measure) |
| Evaluate the tumor response of cetuximab in combination with gemcitabine and carboplatin in patients with EGFr positive, chemotherapy-naive, Stage IV non-small cell lung cancer. [ Time Frame: 3-week cycles with evaluation after every 2 cycles until disease progression or unacceptable toxicity ] [ Designated as safety issue: Yes ] |
| Same as current |
| Complete list of historical versions of study NCT01004731 on ClinicalTrials.gov Archive Site |
| Evaluate the response rate and time to disease progression [ Time Frame: 3-week cycles with evaluation after every 2 cycles until disease progression or unacceptable toxicity ] [ Designated as safety issue: No ] |
| Same as current |
| |
| Study of Anti-Epidermal Growth Factor Receptor (EGFr) Antibody, Cetuximab, in Combination With Gemcitabine/Carboplatin in Patients With Lung Cancer |
| Phase Ib, IIa Study of Anti-Epidermal Growth Factor Receptor (EGFr) Antibody, Cetuximab, in Combination With Gemcitabine/Carboplatin in Patients With Chemotherapy-Naive Stage IV Non-Small Cell Lung Cancer |
The objective is to evaluate the toxicity profile, response rate, and time to progression of Cetuximab administered in combination with either Carboplatin + Gemcitabine in patients with advanced non-small cell lung cancer with positive EGFr expression. |
The primary objective of this study is to evaluate the safety profile of Cetuximab when used in combination with gemcitabine and carboplatin in patients with EGFr positive, chemotherapy-naive, stage IV non-small cell lung cancer (NSCLC).
Also, the study will determine the response rate in patients with EGFr positive chemotherapy-naive, stage IV non-small cell lung cancer (NSCLC) treated with Cetuximab in combination with gemcitabine and carboplatin as well as determine the time to progression in patients with EGFr positive chemotherapy-naive, stage IV NSCLC treated with Cetuximab in combination with gemcitabine and carboplatin. |
| Phase I, Phase II |
| Interventional |
| Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
| Stage IV Non-small Cell Lung Cancer |
| Drug: Cetuximab in combination with Carboplatin/Gemcitabine |
| Experimental: Approximately 30 patients with advanced NSCLC will be enrolled. Patients will receive 3-week cycles of Cetuximab in combination with Carboplatin/Gemcitabine. |
| |
| |
| Completed |
| 7 |
| January 2006 |
| January 2002 (final data collection date for primary outcome measure) |
Inclusion Criteria:
- Have a diagnosis of histologically/cytologically confirmed advanced non- small cell lung cancer (NSCLC).
- Have uni-dimensionally measurable and/or evaluable advanced NSCLC.
- Have Stage IV or recurrent disease following radiation therapy.
- Have ECOG performance status of 0-1 or Karnofsky performance status of 80- 100 at study entry.
- Have given signed informed consent.
- Be at least 18 years of age.
- Have ANC greater than or equal to 1,500/mm3, platelets greater than or equal to 100,000/mm3, WBC greater than or equal to 3,000 mm3, and hemoglobin greater than or equal to 9 g/dL.
- Have total bilirubin less than or equal to 1.5 x upper limits of normal, Alk Phos, AST and ALT less than or equal to 2.5 x upper limits of normal.
- Have serum creatinine less than or equal to 1.5 mg/dL, or calculated creatinine clearance greater than or equal to 60 cc/minute.
- Be disease free from a previously treated malignancy for more than three years. Patients with a history or a previous basal cell carcinoma of the skin or pre-invasive carcinoma of the cervix will not be excluded.
- Agree to use effective contraception if procreative potential exists.
- Must have positive EGFr expression (tumor tissue) by immunohistochemical assay.
Exclusion Criteria:
- Have received prior murine monoclonal antibody or Cetuximab therapy.
- Have disease amenable to curative surgery.
- Have received prior chemotherapy.
- Have received radiation therapy within 3 weeks prior to the first infusion of Cetuximab.
- Have a history of clinically significant cardiac disease, serious arrhythmias, or significant conduction abnormalities, in the judgment of the PI.
- Have uncontrolled seizure disorder, active neurological disease, or Grade 2 or higher neuropathy.
- Be pregnant or breast-feeding.
- Have received any investigational agent(s) within 1 month of study entry.
|
| Both |
| 18 Years and older |
| No |
| Contact information is only displayed when the study is recruiting subjects |
| United States |
| |
| NCT01004731 |
| Francisco Robert, M.D., University of Alabama at Birmingham |
| X010524006, UAB 9909 |
| University of Alabama at Birmingham |
| ImClone LLC |
| Principal Investigator: |
Francisco Robert, M.D. |
University of Alabama at Birmingham |
|
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| University of Alabama at Birmingham |
| November 2009 |