Erlotinib With or Without Carboplatin and Paclitaxel in Treating Patients With Stage III or Stage IV Non-Small Cell Lung Cancer - Full Text View

Sponsors and Collaborators:	Cancer and Leukemia Group B National Cancer Institute (NCI)
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00126581

Purpose

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 giving erlotinib alone or together with carboplatin and paclitaxel works in treating patients with stage III or stage IV non-small cell lung cancer.

Condition	Intervention	Phase
Lung Cancer	Drug: carboplatin Drug: erlotinib hydrochloride Drug: paclitaxel	Phase II

Study Type:	Interventional
Study Design:	Treatment, Randomized
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

Resource links provided by NLM:

MedlinePlus related topics: Cancer Lung Cancer

Drug Information available for: Paclitaxel Carboplatin Erlotinib hydrochloride Erlotinib

U.S. FDA Resources

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:

Progression-free survival (PFS) rate at 18 weeks [ Designated as safety issue: No ]

Secondary Outcome Measures:

Response rate [ Designated as safety issue: No ]
Median and overall survival rate [ Designated as safety issue: No ]
Correlation of response with presence or absence of epidermal growth factor receptor (EGFR) mutations [ Designated as safety issue: No ]
PFS in presence or absence of EGFR mutations [ Designated as safety issue: No ]
Correlation of response and PFS in presence or absence of K-ras mutations [ Designated as safety issue: No ]
Toxicity [ Designated as safety issue: Yes ]

Estimated Enrollment:	180
Study Start Date:	August 2005
Estimated Primary Completion Date:	February 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Arm I: Experimental 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
Arm II: Experimental 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: carboplatin Given IV Drug: erlotinib hydrochloride Given orally Drug: paclitaxel Given IV

Detailed Description:

OBJECTIVES:

Primary

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

Determine the radiographic response rate in patients treated with these regimens.
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.
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.

PROJECTED ACCRUAL: A total of 180 patients (80 for arm I and 100 for arm II) will be accrued for this study within 1.5 years.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

DISEASE CHARACTERISTICS:

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:
- Select stage IIIB disease with cytologically documented malignant pleural or pericardial effusion
- 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)

PATIENT CHARACTERISTICS:

Age

18 and over

Performance status

ECOG 0-1

Life expectancy

Not specified

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

Renal

Creatinine ≤ 1.5 mg/dL

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

Other

Not pregnant or nursing
Negative pregnancy test
Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy

No prior trastuzumab (Herceptin®) or cetuximab

Chemotherapy

No prior chemotherapy, including neoadjuvant or adjuvant chemotherapy
No other concurrent chemotherapy

Endocrine therapy

See Disease Characteristics
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

Radiotherapy

At least 3 weeks since prior radiotherapy, including cranial irradiation
No concurrent radiotherapy, including palliative radiotherapy

Surgery

At least 3 weeks since prior major surgery
No prior significant surgical resection of the stomach or small bowel

Other

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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00126581

Show 42 Study Locations

Sponsors and Collaborators

Cancer and Leukemia Group B

National Cancer Institute (NCI)

Investigators

Study Chair:	Pasi Janne, MD, PhD	Dana-Farber Cancer Institute
Investigator:	Vincent A. Miller, MD	Memorial Sloan-Kettering Cancer Center

More Information

Additional Information:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

Featured trial article This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Cancer and Leukemia Group B ( Richard L. Schilsky )
Study ID Numbers:	CDR0000437097, CALGB-30406
Study First Received:	August 2, 2005
Last Updated:	August 13, 2009
ClinicalTrials.gov Identifier:	NCT00126581 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by National Cancer Institute (NCI):

adenocarcinoma of the lung
adenosquamous cell lung cancer
bronchoalveolar cell lung cancer

stage IIIB non-small cell lung cancer
stage IV non-small cell lung cancer
recurrent non-small cell lung cancer

Study placed in the following topic categories:

Erlotinib
Thoracic Neoplasms
Adenocarcinoma, Bronchiolo-Alveolar
Antimitotic Agents
Carboplatin
Protein Kinase Inhibitors
Recurrence
Carcinoma
Respiratory Tract Diseases
Lung Neoplasms

Paclitaxel
Lung Diseases
Tubulin Modulators
Non-small Cell Lung Cancer
Adenocarcinoma of Lung
Adenocarcinoma
Antineoplastic Agents, Phytogenic
Carcinoma, Non-Small-Cell Lung
Neoplasms, Glandular and Epithelial

Additional relevant MeSH terms:

Erlotinib
Thoracic Neoplasms
Respiratory Tract Neoplasms
Neoplasms by Histologic Type
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Mitosis Modulators
Enzyme Inhibitors
Antimitotic Agents
Carboplatin
Protein Kinase Inhibitors
Pharmacologic Actions

Carcinoma
Neoplasms
Neoplasms by Site
Respiratory Tract Diseases
Lung Neoplasms
Paclitaxel
Therapeutic Uses
Lung Diseases
Tubulin Modulators
Antineoplastic Agents, Phytogenic
Carcinoma, Non-Small-Cell Lung
Neoplasms, Glandular and Epithelial

ClinicalTrials.gov processed this record on September 10, 2009