S0709: Erlotinib With or Without Carboplatin and Paclitaxel in Stage IIIB or Stage IV Non-Small Cell Lung Cancer



Status:Completed
Conditions:Lung Cancer, Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - 120
Updated:4/17/2018
Start Date:December 2008
End Date:December 2016

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A Phase II Selection Design of Pharmacodynamic Separation of Carboplatin/Paclitaxel/OSI-774 (Erlotinib; NSC-718781) or OSI-774 Alone in Advanced Non-Small Cell Lung Cancer (NSCLC) Patients With Performance Status 2 (PS-2)

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 to stop the growth of tumor cells, either by killing the cells or by
stopping them from dividing. Giving erlotinib together with carboplatin and paclitaxel may
kill more tumor cells.

PURPOSE: This randomized phase II trial is studying how well erlotinib works when given alone
or together with carboplatin and paclitaxel in treating patients with stage IIIB or stage IV
non-small cell lung cancer.

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
survival for ≥ 3 months, in patients with stage IIIB or IV non-small cell lung cancer
with a Zubrod performance status of 2.

Secondary

- To assess the feasibility of selecting patients for a trial based on central EGFR
testing of serum in a cooperative group setting.

- To evaluate the objective tumor response rates (confirmed and unconfirmed, complete and
partial response), in a subset of patients with measurable disease.

OUTLINE: This is a multicenter study. Patients are randomized to 1 of 2 treatment arms.

- Arm I: Patients receive oral erlotinib hydrochloride once daily on days 1-21. Courses
repeat every 21 days in the absence of disease progression or unacceptable toxicity.

- Arm II: Patients receive paclitaxel IV over 3 hours and carboplatin IV over 30 minutes
on day 1 and oral erlotinib hydrochloride once daily on days 2-16. Treatment repeats
every 21 days for 4 courses. Beginning in course 5 and for all subsequent courses,
patients receive oral erlotinib hydrochloride alone on days 1-21. Courses with erlotinib
hydrochloride repeat every 21 days in the absence of disease progression or unacceptable
toxicity.

After completion of study treatment, patients are followed every 3 months for 1 year and then
every 6 months for 2 years.

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

- 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
We found this trial at
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200 Hawthorne Lane
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19229 Mack Ave
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1415 E. Kincaid
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Skagit Valley Hospital Cancer Care Center We know that treatment takes its toll physically, emotionally...
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19500 10th Ave NE # 100
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University of California Davis Cancer Center At UC Davis Comprehensive Cancer Center, specialized teams of...
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Group Health Central Hospital Group Health Cooperative is a member-governed, nonprofit health care system that...
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142 S Main St
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