Status:
COMPLETED
S0709: Erlotinib With or Without Carboplatin and Paclitaxel in Stage IIIB or Stage IV Non-Small Cell Lung Cancer
Lead Sponsor:
SWOG Cancer Research Network
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Lung Cancer
Eligibility:
All Genders
18-120 years
Phase:
PHASE2
Brief Summary
RATIONALE: Erlotinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as carboplatin and paclitaxel, work in different ways t...
Detailed Description
OBJECTIVES: Primary * To select a regimen (erlotinib hydrochloride with or without carboplatin and paclitaxel) for further testing against standard treatment, based on median progression-free surviv...
Eligibility Criteria
Inclusion
- DISEASE CHARACTERISTICS:
- Histologically or cytologically confirmed non-small cell lung cancer (NSCLC), including any of the following subtypes:
- Adenocarcinoma
- Large cell carcinoma
- Squamous cell carcinoma
- Unspecified
- Newly diagnosed primary disease OR recurrent disease after prior surgery and/or radiotherapy, meeting 1 of the following staging criteria:
- Selected stage IIIB disease (T4 \[secondary to malignant pleural effusion only\], any N, M0)
- Stage IV disease (any T, any N, M1 \[distant metastases present\])
- Measurable or nonmeasurable disease by CT scan, MRI, x-ray, physical exam, or nuclear scan
- The CT scan from a combined PET/CT scan may only be used to document nonmeasurable disease
- Pleural effusions, ascites, and laboratory parameters are not acceptable as the only evidence of disease
- Shows evidence of EGFR tyrosine kinase inhibitor therapy benefit (i.e., "proteomics positive") prior to study registration
- No untreated brain metastases
- Patients with treated brain metastases are allowed provided metastases have remained controlled for at least two weeks following treatment, AND patient has no residual neurological dysfunction off corticosteroids
- Patients with neurologic abnormalities on physical examination or symptoms must have a negative pretreatment CT or MRI scan of the brain 28 days prior to registration
- PATIENT CHARACTERISTICS:
- Zubrod performance status 2
- ANC ≥ 1,500/mm³
- Platelet count ≥ 1,000/mm³
- Serum bilirubin normal
- SGOT or SGPT normal
- Serum creatinine ≤ 2 times upper limit of normal OR creatinine clearance ≥ 50 mL/min
- Willing to provide prior smoking history as requested on the prestudy form
- No gastrointestinal (GI) tract disease resulting in an inability to take enteral medication
- No malabsorption syndrome or requirement for IV alimentation
- No uncontrolled inflammatory GI disease (e.g., Crohn's disease or ulcerative colitis)
- No significant history of cardiac disease, including any of the following:
- Uncontrolled high blood pressure
- Unstable angina
- Congestive heart failure
- Myocardial infarction within the past 6 months
- Cardiac ventricular arrhythmia requiring medication
- No other prior malignancy except adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, adequately treated stage I or II cancer from which the patient is currently in complete remission, or any other cancer from which the patient has been disease-free for 5 years
- Not pregnant or nursing
- Fertile patients must use effective contraception
- PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
- At least 3 weeks since prior radiotherapy or surgery (thoracic or other major surgery) and recovered
- At least 1 year since prior adjuvant chemotherapy
- No prior systemic hormonal therapy, chemotherapy, or biological therapy for advanced NSCLC
- No prior EGFR inhibitors
- No prior surgical procedures affecting absorption
- No concurrent major surgery
Exclusion
Key Trial Info
Start Date :
December 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2016
Estimated Enrollment :
59 Patients enrolled
Trial Details
Trial ID
NCT00661193
Start Date
December 1 2008
End Date
December 1 2016
Last Update
February 20 2020
Active Locations (124)
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1
Arkansas Cancer Research Center at University of Arkansas for Medical Sciences
Little Rock, Arkansas, United States, 72205
2
Kaiser Permanente - Deer Valley
Antioch, California, United States, 94531
3
Alta Bates Summit Comprehensive Cancer Center
Berkeley, California, United States, 94704
4
Peninsula Medical Center
Burlingame, California, United States, 94010