Erlotinib With or Without Carboplatin and Paclitaxel in Treating Patients With Stage III or Stage IV Non-Small Cell Lung Cancer
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Purpose
This randomized phase II trial is studying how well giving erlotinib alone or together with carboplatin and paclitaxel works in treating patients with stage III or stage IV non-small cell lung cancer. 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
| Condition | Intervention | Phase |
|---|---|---|
|
Adenocarcinoma of the Lung Adenosquamous Cell Lung Cancer Bronchoalveolar Cell Lung Cancer Lung Cancer Recurrent Non-small Cell Lung Cancer Stage IIIB Non-small Cell Lung Cancer Stage IV Non-small Cell Lung Cancer |
Drug: erlotinib hydrochloride Drug: paclitaxel Drug: carboplatin |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Phase II Randomized Study of OSI-774 (Erlotinib) (NSC #718781; IND# 63,383) With or Without Carboplatin/Paclitaxel in Patients With Previously Untreated Adenocarcinoma of the Lung Who Never Smoked or Were Former Light Smokers |
- Progression-free survival (PFS) rate [ Time Frame: At 18 weeks ] [ Designated as safety issue: No ]The product limit estimator developed by Kaplan and Meier will be used to graphically describe progression free survival for patients randomized to each study arm.
- Response rate [ Time Frame: Up to 3 years ] [ Designated as safety issue: No ]The proportion of patients who respond (completely or partially) to each combination regimen will be estimated. An exact binomial confidence interval will be computed for these estimates.
- Toxicity assessed using NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 [ Time Frame: Up to 3 years ] [ Designated as safety issue: Yes ]The toxicity associated with each treatment regimen will be summarized. For each type of toxicity, a patient's worst treatment-related toxic episode will be used to summarize distribution of toxicity grade experienced.
- Mutations in EGFR and K-ras [ Time Frame: Up to 3 years ] [ Designated as safety issue: No ]Univariate analysis will be performed using a log rank test to correlate mutations (EGFR and K-ras) with the PFS. A Cox proportional hazard regression in a multivariable fashion will be used to correlate mutations with survival while adjusting for other prognostic factors. The frequency of tumor response by mutations will be tabulated and their association will be tested by Fisher's exact method. Logistic regression will be used to explore the joint effects of mutations as well as other prognostic factors on tumor response.
- Mutations in ErbB-2 and B-raf [ Time Frame: Up to 3 years ] [ Designated as safety issue: No ]The association of ErbB-2 and B-raf mutations with response to OSI-774 (erlotinib) or OSI-774 (erlotinib)/chemotherapy will be tested by Fisher's exact test.
| Estimated Enrollment: | 180 |
| Study Start Date: | August 2005 |
| Primary Completion Date: | June 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Arm I
Patients receive oral erlotinib once daily on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
|
Drug: erlotinib hydrochloride
Given orally
Other Names:
|
|
Experimental: Arm II
Patients receive erlotinib as in arm I. Patients also receive paclitaxel IV over 1-3 hours and carboplatin IV over 15-30 minutes on day 1. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. After completion of 6 courses of treatment, patients may continue to receive erlotinib alone as above
|
Drug: erlotinib hydrochloride
Given orally
Other Names:
Drug: paclitaxel
Given IV
Other Names:
Drug: carboplatin
Given IV
Other Names:
|
Detailed Description:
PRIMARY OBJECTIVES:
I. Determine the progression-free survival of patients with chemotherapy-naïve select stage IIIB or stage IV non-small cell lung cancer treated with erlotinib with or without carboplatin and paclitaxel.
SECONDARY OBJECTIVES:
I. Determine the radiographic response rate in patients treated with these regimens.
II. Correlate the frequency of epidermal growth factor receptor (EGFR) mutations and K-ras mutations with the response rate and time to progression in patients treated with these regimens.
III. Determine the median and overall survival of patients treated with these regimens.
OUTLINE: This is a randomized, multicenter study. Patients are randomized to 1 of 2 treatment arms.
ARM I: Patients receive oral erlotinib once daily on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
ARM II: Patients receive erlotinib as in arm I. Patients also receive paclitaxel IV over 1-3 hours and carboplatin IV over 15-30 minutes on day 1. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. After completion of 6 courses of treatment, patients may continue to receive erlotinib alone as above.
After completion of study treatment, patients are followed at least every 3 months for 1 year and then every 6 months for up to 2 years.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Renal: Creatinine =< 1.5 mg/dL
- Histologically confirmed primary non-small cell lung cancer (NSCLC)
- Adenocarcinoma histology, including any of the following histologic variants: pure or mixed bronchoalveolar cell carcinoma, adenosquamous cell carcinoma
- No NSCLC not otherwise specified
- Pathology block or unstained slides from initial or subsequent diagnosis available
- At least a core biopsy required
- Fine needle aspirate alone is not sufficient
Meets 1 of the following stage criteria: s
- elect stage IIIB disease with cytologically documented malignant pleural or
- pericardial effusion or stage IV disease
- Measurable disease, defined as >= 1 unidimensionally measurable lesion >= 20 mm by conventional techniques OR >= 10 mm by spiral CT scan
The following are considered non-measurable disease:
- bone lesions,
- leptomeningeal disease;
- ascites;
- pleural or pericardial effusion;
- lymphangitis cutis/pulmonis;
- abdominal masses not confirmed and followed by imaging techniques;
- cystic lesions
Meets 1 of the following criteria for smoking history:
- non-smoker,
- defined as a person who smoked =< 100 cigarettes in their lifetime;
- former light smoker,
- defined as a person who smoked =< 10 pack years AND
- quit smoking >= 1 year ago
- No uncontrolled CNS metastases (i.e., any known CNS lesion that is radiographically unstable, symptomatic, and/or requires corticosteroids)
- ECOG 0-1
Hematopoietic:
- Granulocyte count >= 1,500/mm^3;
- Platelet count >= 100,000/mm^3;
- Hemoglobin >= 9.0 g/dL
Hepatic:
- AST =< 2.5 times upper limit of normal (ULN);
- Total bilirubin =< ULN
Gastrointestinal:
- Able to swallow tablets intact or dissolved in water;
- no dysphagia;
- no active gastrointestinal disease or disorder that would alter gastrointestinal motility or absorption;
- no lack of integrity of the gastrointestinal tract
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- No prior trastuzumab (Herceptin) or cetuximab
- No prior chemotherapy, including neoadjuvant or adjuvant chemotherapy
- No other concurrent chemotherapy
No concurrent hormonal therapy except for the following:
- hormones for non-disease-related conditions (e.g., insulin for diabetes);
- steroids for adrenal failure;
- intermittent use of dexamethasone as an antiemetic or to prevent paclitaxel hypersensitivity reactions
- At least 3 weeks since prior radiotherapy, including cranial irradiation
- No concurrent radiotherapy, including palliative radiotherapy
- At least 3 weeks since prior major surgery
- No prior significant surgical resection of the stomach or small bowel
- No prior erlotinib, gefitinib, or lapatinib
- No other prior treatment targeting the HER family axis
- More than 4 weeks since prior and no other concurrent investigational agents
Contacts and Locations
Show 79 Study Locations| Principal Investigator: | Pasi Janne | Cancer and Leukemia Group B |
More Information
No publications provided
| Responsible Party: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00126581 History of Changes |
| Other Study ID Numbers: | NCI-2009-00464, CALGB-30406, U10CA031946, CDR0000437097 |
| Study First Received: | August 2, 2005 |
| Last Updated: | January 8, 2013 |
| Health Authority: | United States: Food and Drug Administration |
Additional relevant MeSH terms:
|
Adenocarcinoma Adenocarcinoma, Mucinous Adenocarcinoma, Bronchiolo-Alveolar Carcinoma, Non-Small-Cell Lung Lung Neoplasms Carcinoma Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms Neoplasms, Cystic, Mucinous, and Serous Carcinoma, Bronchogenic Bronchial Neoplasms Respiratory Tract Neoplasms Thoracic Neoplasms Neoplasms by Site |
Lung Diseases Respiratory Tract Diseases Carboplatin Paclitaxel Erlotinib Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Tubulin Modulators Antimitotic Agents Mitosis Modulators Molecular Mechanisms of Pharmacological Action Antineoplastic Agents, Phytogenic Protein Kinase Inhibitors Enzyme Inhibitors |
ClinicalTrials.gov processed this record on June 18, 2013