Erlotinib, Paclitaxel, and Carboplatin in Treating Patients With Stage III, Stage IV, or Recurrent Non-Small Cell Lung Cancer

NCT00287989 | Completed Phase 2 Results

• 6 other identifiers: J0432P30CA006973JHOC-J0432JHOC-WIRB-20041142CDR000045511620-04-11-42
• Study Type: interventional
• Target: 86
• Locations: 1 country
• Sites: 2

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 paclitaxel and carboplatin, 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 paclitaxel and carboplatin may kill more tumor cells. PURPOSE: This randomized phase II trial is studying two different doses of erlotinib when given together with paclitaxel and carboplatin to compare how well they work in treating patients with stage III, stage IV, or recurrent non-small cell lung cancer.

Conditions

Lung Cancer

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Overall Response Rate

  Percentage of patients who experienced complete or partial response as defined by RECIST

  after 6 cycles of chemotherapy

Secondary Outcomes (1)

• Time to Progression

  after cycle 6 of chemotherapy

Study Arms (3)

150 PRE

EXPERIMENTAL

Erlotinib 150mg on days 1 and 2 of a 21 day cycle and Carboplatin AUC6 and Paclitaxel 200 mg/m2

Drug: Carboplatin; Drug: erlotinib hydrochloride; Drug: Paclitaxel

1,500 PRE

EXPERIMENTAL

Erlotinib 1500mg on Days 1 and 2 of a 21 day cycle and Carboplatin AUC6 and Paclitaxel 200mg/m2

Drug: Carboplatin; Drug: Paclitaxel; Drug: erlotinib hydrochloride

1,500 POST

EXPERIMENTAL

Carboplatin AUC6, Paclitaxel 200 mg/m2 followed by Erlotinib 1500mg days 2 and 3.

Drug: Carboplatin; Drug: Paclitaxel; Drug: erlotinib hydrochloride

Interventions

Carboplatin DRUG

Also known as: Carboplatin AUC6

1,500 POST; 1,500 PRE; 150 PRE

erlotinib hydrochloride DRUG

150mg

Also known as: Erlotinib

150 PRE

Paclitaxel DRUG

200mg/m2

1,500 POST; 1,500 PRE; 150 PRE

Eligibility Criteria

• Age: 18 Years - 120 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

DISEASE CHARACTERISTICS: * Pathologically confirmed non-small cell lung cancer * Stage IIIB or IV or recurrent disease * Measurable or evaluable indicator lesions * Must have smoked ≥ 100 cigarettes in his/her lifetime PATIENT CHARACTERISTICS: * Karnofsky performance status 70-100% * WBC ≥ 4,000/mm\^3 * Platelet count ≥ 100,000/mm\^3 * Creatinine ≤ 1.5 mg/dL OR creatinine clearance ≥ 50 mL/min * Bilirubin ≤ 1.0 mg/dL * AST ≤ 2.5 times upper limit of normal (ULN) * Alkaline phosphatase ≤ 2.5 times ULN * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception during and for ≥ 1 week after completion of study treatment * No gastrointestinal tract disease or inability to take oral medication * No prior malignancy within the past 2 years except nonmelanoma skin cancer or carcinoma in situ of the cervix * No other active medical problems, including severe infection, unstable angina, or myocardial infarction within the past 6 months * No poorly controlled hypertension or severe malnutrition * No New York Heart Association class III or IV congestive heart failure or serious cardiac arrhythmia requiring medication except chronic atrial arrhythmia (i.e., atrial fibrillation or paroxysmal supraventricular tachycardia) PRIOR CONCURRENT THERAPY: * At least 3 weeks since prior radiotherapy to major bone marrow-containing sites * No prior chemotherapy for advanced non-small cell lung cancer * No prior agents directed at the epidermal growth factor receptor (EGFR)/HER axis (e.g., gefitinib, cetuximab, or trastuzumab \[Herceptin®\]) * No prior surgical procedure resulting in abnormal absorption of oral medications * No concurrent surgical resection, palliative radiotherapy, or hormonal therapy * No other concurrent anticancer therapy

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins: lead
• National Cancer Institute (NCI): collaborator

Study Sites (2)

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Baltimore, Maryland, 21231-2410, United States

Location

Memorial Sloan-Kettering Cancer Center

New York, New York, 10021, United States

Location

Related Publications (1)

• Riely GJ, Rizvi NA, Kris MG, Milton DT, Solit DB, Rosen N, Senturk E, Azzoli CG, Brahmer JR, Sirotnak FM, Seshan VE, Fogle M, Ginsberg M, Miller VA, Rudin CM. Randomized phase II study of pulse erlotinib before or after carboplatin and paclitaxel in current or former smokers with advanced non-small-cell lung cancer. J Clin Oncol. 2009 Jan 10;27(2):264-70. doi: 10.1200/JCO.2008.17.4656. Epub 2008 Dec 1.

  PMID: 19047285 RESULT

MeSH Terms

Conditions

Lung Neoplasms; Carcinoma, Non-Small-Cell Lung

Interventions

Carboplatin; Erlotinib Hydrochloride; Paclitaxel

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Carcinoma, Bronchogenic; Bronchial Neoplasms

Intervention Hierarchy (Ancestors)

Coordination Complexes; Organic Chemicals; Quinazolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Diterpenes; Terpenes

Limitations and Caveats

The design of the study was change during the course of this research.

Results Point of Contact

• Title: Charles M. Rudin, MD, PhD.
• Organization: MSKCC

rudinc@mskcc.org

646-888-4527

Study Officials

• Charles M. Rudin, MD, PhD

  Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 6, 2006
• First Posted: February 7, 2006
• Study Start: November 1, 2004
• Primary Completion: August 1, 2007
• Study Completion: May 1, 2009
• Last Updated: December 6, 2018
• Results First Posted: December 6, 2018

Record last verified: 2018-11

Locations

US (2)