Cetuximab, Paclitaxel, Carboplatin, and Radiation Therapy in Treating Patients With Unresectable Stage IIIA or Stage IIIB Non-Small Cell Lung Cancer

NCT00081302 | Completed Phase 2 DMC

• 2 other identifiers: RTOG-0324CDR0000352163
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

RATIONALE: Monoclonal antibodies such as cetuximab can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. Drugs used in chemotherapy, such as paclitaxel and carboplatin, work in different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Giving cetuximab together with combination chemotherapy and radiation therapy may kill more tumor cells. PURPOSE: This phase II trial is studying how well giving cetuximab together with paclitaxel, carboplatin, and radiation therapy works in treating patients with unresectable stage IIIA or stage IIIB non-small cell lung cancer.

Conditions

Lung Cancer

Keywords

stage IIIA non-small cell lung cancer; stage IIIB non-small cell lung cancer; squamous cell lung cancer; large cell lung cancer; adenocarcinoma of the lung; bronchoalveolar cell lung cancer

Interventions

cetuximab BIOLOGICAL

carboplatin DRUG

paclitaxel DRUG

radiation therapy RADIATION

Eligibility Criteria

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

DISEASE CHARACTERISTICS: * Histologically or cytologically confirmed non-small cell lung cancer (NSCLC) of 1 of the following subtypes: * Squamous cell carcinoma * Adenocarcinoma (including bronchoalveolar cell) * Large cell anaplastic carcinoma (including giant and clear cell carcinomas) * Poorly differentiated/not otherwise specified NSCLC * Stage IIIA (T1-2, N2, M0 or T3, N1-2, M0) or IIIB (T4, any N, M0 or any T, N2-3, M0) * If the largest mediastinal node is \< 2.0 cm in diameter and this is the basis for stage III disease, then at least 1 of the nodes must be cytologically or histologically positive * Unresectable disease * No totally resected tumors * Tumors adjacent to a vertebral body allowed provided all gross disease can be encompassed in the radiation boost field and the boost volume is limited to \< 50% of the ipsilateral lung volume * Measurable disease * Transudate, cytologically negative, non-bloody pleural effusions allowed provided the tumor can be encompassed within a reasonable field of radiotherapy * Pleural effusions seen on a chest CT scan are allowed provided they are not visible on a chest x-ray and are too small to tap * No asymptomatic or symptomatic brain metastases PATIENT CHARACTERISTICS: Age * 18 and over Performance status * Zubrod 0-1 Life expectancy * Not specified Hematopoietic * Absolute neutrophil count ≥ 1,500/mm\^3 * Platelet count ≥ 100,000/mm\^3 * Hemoglobin ≥ 9 g/dL (transfusion independent) Hepatic * Bilirubin ≤ 1.5 mg/dL * SGOT (serum glutamic oxaloacetic transaminase) or SGPT (serum glutamate pyruvate transaminase) ≤ 3 times upper limit of normal (ULN) * Alkaline phosphatase ≤ 2.5 times ULN Renal * Creatinine ≤ 2.0 mg/dL Cardiovascular * No significant history of cardiac disease * No uncontrolled hypertension * No unstable angina * No uncompensated congestive heart failure * No myocardial infarction within the past year * No cardiac ventricular arrhythmias requiring medication * LVEF (left ventricular ejection fraction) normal by MUGA (multi-gated acquisition) scan or echocardiogram Pulmonary * No history of interstitial pneumonitis * No history of severe chronic obstructive pulmonary disease requiring 3 or more hospitalizations within the past year * FEV\_1 ≥ 1,200 cc * No active pulmonary infection unresponsive to conventional antibiotics Other * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception during and for 4 weeks after study therapy * Glucose ≤ 2 times ULN * No more than 5% weight loss within the past 3 months * No known allergy to murine proteins or Cremophor EL * No neuropathy grade 2 or greater * No other malignancy within the past 2 years except adequately treated basal cell or squamous cell skin cancer, carcinoma in situ of the cervix, or other in situ cancers PRIOR CONCURRENT THERAPY: Biologic therapy * No prior drugs that target the epidermal growth factor receptor pathway * No prior chimerized monoclonal antibody therapy * No other concurrent immunotherapy * No concurrent colony-stimulating factors (i.e., filgrastim \[G-CSF\] and sargramostim \[GM-CSF\]) * Concurrent epoetin alfa allowed Chemotherapy * No prior systemic chemotherapy * No other concurrent chemotherapy Endocrine therapy * No concurrent hormonal therapy except hormones for non-disease-related conditions (e.g., insulin for diabetes) or steroids for acute symptom management, adrenal failure, septic shock, or as antiemetics Radiotherapy * No prior thoracic or neck radiotherapy * No concurrent intensity-modulated radiotherapy Surgery * Recovered from prior exploratory thoracotomy * No prior surgical resection of the present cancer Other * More than 30 days since prior participation in another clinical trial * No concurrent participation in another clinical trial * No other concurrent anticancer therapy * No amifostine during or for 3 months after study radiotherapy

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

Sponsors & Collaborators

• Radiation Therapy Oncology Group: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Arlington Cancer Center - Arlington

Arlington, Texas, 76012, United States

Location

Related Publications (6)

• Blumenschein GR Jr, Paulus R, Curran WJ, Robert F, Fossella F, Werner-Wasik M, Herbst RS, Doescher PO, Choy H, Komaki R. Phase II study of cetuximab in combination with chemoradiation in patients with stage IIIA/B non-small-cell lung cancer: RTOG 0324. J Clin Oncol. 2011 Jun 10;29(17):2312-8. doi: 10.1200/JCO.2010.31.7875. Epub 2011 May 9.

  PMID: 21555682 RESULT

• Blumenschein GR, Paulus R, Curran WJ, et al.: A phase II study of cetuximab (C225) in combination with chemoradiation (CRT) in patients (PTS) with stage IIIA/B non-small cell lung cancer (NSCLC): A report of the 2 year and median survival (MS) for the RTOG 0324 trial. [Abstract] J Clin Oncol 26 (Suppl 15): A-7516, 2008.

  RESULT

• Olsen CC, Paulus R, Komaki R, et al.: RTOG 0324: A phase II study of cetuximab (C225) in combination with chemoradiation (CRT) in patients with stage IIIA/B non-small cell lung cancer (NSCLC)--Association between EGFR gene copy number and patients' outcome. [Abstract] J Clin Oncol 26 (Suppl 15): A-7607, 2008.

  RESULT

• Blumenschein G Jr, Moughan J, Curran W, et al.: A phase II study of cetuximab (C225) in combination with chemoradiation (CRT) in patients (pts) with stage III A/B non-small cell lung cancer (NSCLC): an interim report of the RTOG 0324 trial. [Abstract] J Clin Oncol 25 (Suppl 18): A-7531, 392s, 2007.

  RESULT

• Komaki R, Moughan J, Ang K, et al.: RTOG 0324: a phase II study of cetuximab (C225) in combination with chemoradiation (CRT) in patients (PTS) with stage IIIA/B non-small cell lung cancer (NSCLC): correlation between EGFR expression and the patients' outcome. [Abstract] Int J Radiat Oncol Biol Phys 69 (3 Suppl): A-101, S57-58, 2007.

  RESULT

• Werner-Wasik M, Swann S, Curran W, et al.: A phase II study of cetuximab (C225) in combination with chemoradiation (CRT) in patients (PTS) with stage IIIA/B non-small cell lung cancer (NSCLC): an interim overall toxicity report of the RTOG 0324 trial. [Abstract] J Clin Oncol 23 (Suppl 16): A-7135, 654s, 2005.

  RESULT

MeSH Terms

Conditions

Lung Neoplasms; Carcinoma, Non-Small-Cell Lung; Adenocarcinoma of Lung; Adenocarcinoma, Bronchiolo-Alveolar

Interventions

Cetuximab; Carboplatin; Paclitaxel; Radiotherapy

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Carcinoma, Bronchogenic; Bronchial Neoplasms; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Coordination Complexes; Organic Chemicals; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Diterpenes; Terpenes; Therapeutics

Study Officials

• George R. Blumenschein, MD

  M.D. Anderson Cancer Center

  STUDY CHAIR

Study Design

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

Study Record Dates

• First Submitted: April 7, 2004
• First Posted: April 8, 2004
• Study Start: March 1, 2004
• Primary Completion: December 1, 2005
• Study Completion: November 1, 2013
• Last Updated: November 17, 2015

Record last verified: 2015-11

Locations

US (1)