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Phase II Randomized, Open-Label Study of Cetuximab and Bevacizumab in Combination With Paclitaxel and Carboplatin in Patients With Stage IIIB/IV Non-Small Cell Lung Cancer


Phase 2
18 Years
N/A
Not Enrolling
Both
Non-Small Cell Lung Cancer

Thank you

Trial Information

Phase II Randomized, Open-Label Study of Cetuximab and Bevacizumab in Combination With Paclitaxel and Carboplatin in Patients With Stage IIIB/IV Non-Small Cell Lung Cancer


Inclusion Criteria:



- The patient has histologically or cytologically confirmed non-small cell lung cancer
(NSCLC), except squamous cell carcinoma. Mixed tumors will be categorized by the
predominant cell type, but the presence of small cell lung cancer elements will make
the patient ineligible. Cytologic or histologic elements can be established on
metastatic tumor aspirates or biopsy.

- The patient has advanced NSCLC (Stage IIIB with malignant pleural effusion or Stage
IV or recurrent disease).

- Patients must have measurable disease as defined by Response Evaluation Criteria in
Solid Tumors (RECIST).

- The patient's Eastern Cooperative Oncology Group (ECOG) performance status is 0 or 1.

- The patient has adequate hematologic function as defined by an Absolute Neutrophil
Count greater than or equal to 1500/mm³,hemoglobin greater than or equal to 9 gm/dL,
and a platelet count greater than or equal to 100,000/mm³ obtained within 2 weeks
prior to the first dose of study medication.

- The patient has adequate hepatic function as defined by a total bilirubin greater
than or equal to 1.5 mg/dL and transaminases and alkaline phosphatase less than or
equal to 5 x the Upper Limit of Normal (ULN) obtained within 2 weeks prior to the
first dose of study medication.

- The patient has adequate renal function as defined by serum creatinine less than or
equal to 1.5 x ULN or calculated creatinine clearance (CrCl) >60 mL/minute, and urine
dipstick for proteinuria <1+ (ie, either 0 or trace) obtained within 2 weeks prior to
the first dose of study medication. If urine dipstick is greater than or equal to 1+,
then a 24-hour urine for protein must demonstrate <500 mg of protein in 24 hours to
allow participation in the study.

- The patient has adequate coagulation function as defined by International Normalized
Ratio less than or equal to 1.5 and a Prothrombin time and partial thromboplastin
time less than or equal to ULN obtained within 2 weeks prior to the first dose of
study medication.

- The patient, if a woman of childbearing potential, agrees to use an accepted and
effective method of contraception (hormonal or barrier methods, abstinence) prior to
study entry and for the duration of the study. If a male and sexually active, the
patient agrees to use effective contraception.

Exclusion Criteria:

- The patient has known Central Nervous System metastases. A head computed tomography
(CT) is required within 4 weeks prior to the first dose of study medication (magnetic
resonance imagines [MRIs] are also acceptable).

- The patient has received prior cetuximab therapy.

- The patient has received prior bevacizumab therapy.

- The patient has received prior systemic chemotherapy or radiation therapy at any time
for lung cancer.

- Any concurrent malignancy other than basal cell skin cancer, or carcinoma in situ of
the cervix. Patients with adequately treated cancers of other histologies who have
been disease-free for more than 3 years prior to the first treatment dose are
eligible.

- Concurrent treatment with other anti-cancer therapy, including other chemotherapy,
immunotherapy, hormonal therapy, radiotherapy, chemoembolization, or targeted
therapy.

- The patient has an ongoing or active infection, symptomatic congestive heart failure,
unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social
situations that would limit compliance with study requirements.

- The patient has a history of thrombotic or hemorrhagic disorders.

- The patient has uncontrolled hypertension (>150/100 mmHg) on a standard regimen of
anti-hypertensive therapy.

- The patient is receiving chronic daily treatment with aspirin (>325 mg/day) or
nonsteroidal anti-inflammatory agents known to inhibit platelet function.

- The patient is receiving treatment with dipyridamole (Persantine®), ticlopidine
(Ticlid®), clopidogrel (Plavix®) and /or cilostazol (Pletal®).

- The patient is receiving anti-coagulation therapy. Prophylactic anti-coagulation of
venous access devices is allowed. Caution should be taken on treating patients with
low dose heparin or low molecular weight heparin for deep vein thrombosis (DVT)
prophylaxis during treatment with bevacizumab as there may be an increased risk of
bleeding.

- Patients with a history of gross hemoptysis (defined as bright red blood or greater
than or equal to ½ teaspoon).

- The patient has a serious non-healing wound ulcer, bone fracture, or major surgical
procedure within 30 days prior to first dose of study medication.

- Elective or planned major surgery to be performed during the course of the trial.

- The patient has a pre-existing neuropathy >grade 1.

- The patient, if a woman, is pregnant or lactating.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Progression Free Survival (PFS)

Outcome Description:

PFS is defined as the time from randomization until the date of progression of disease (PD) or death from any cause. PD was determined using Response Evaluation Criteria In Solid Tumors (RECIST) criteria. PD ≥20% increase in sum of longest diameter of target lesions. Participants who are alive and without PD will be censored at the date of their last tumor assessment.

Outcome Time Frame:

Randomization to PD or date of death from any cause up to 33.1 months

Safety Issue:

No

Principal Investigator

Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)

Investigator Role:

Study Director

Investigator Affiliation:

Eli Lilly and Company

Authority:

United States: Food and Drug Administration

Study ID:

13421

NCT ID:

NCT00343291

Start Date:

December 2006

Completion Date:

December 2010

Related Keywords:

  • Non-Small Cell Lung Cancer
  • Non-Small Cell Lung Cancer
  • Malignant pleural effusions
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms

Name

Location

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.Durham, North Carolina  
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.Birmingham, Alabama  35294
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.Phoenix, Arizona  85012
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.Greenbrae, California  94904
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.Stamford, Connecticut  06902
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.Jacksonville, Florida  32256
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.Athens, Georgia  30607
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.Chicago, Illinois  60674
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.Overland Park, Kansas  66210
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.Metairie, Louisiana  70006
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.Bethesda, Maryland  20817
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.Kalamazoo, Michigan  49048
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.St Joseph, Missouri  64507
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.Las Vegas, Nevada  89169
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.Tulsa, Oklahoma  74136
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.Dunmore, Pennsylvania  18512
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.Greenville, South Carolina  29605
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.Memphis, Tennessee  38138
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.Bedford, Texas  76022
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.Seattle, Washington  98133
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.Omaha, Nebraska  68114
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.Lexington, Kentucky  40536