Erlotinib, Paclitaxel, and Carboplatin Combined With Radiation Therapy for Stage III Non-Small Cell Lung Cancer

NCT00278148 | Completed Phase 1 Results DMC

• 3 other identifiers: CCF5876P30CA043703CCF-5876
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

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. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving erlotinib, paclitaxel, and carboplatin together with radiation therapy before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed. Giving these treatments after surgery may kill any tumor cells that remain after surgery. PURPOSE: This phase I/II trial is studying the best dose of erlotinib and the side effects of erlotinib, paclitaxel, and carboplatin when given together with radiation therapy and to see how well they work in treating patients who are undergoing surgery for stage III non-small cell lung cancer.

Conditions

Lung Cancer

Keywords

stage IIIA non-small cell lung cancer; stage IIIB non-small cell lung cancer

Outcome Measures

Primary Outcomes (2)

• Maximum Tolerated Dose of Erlotinib Hydrochloride (Phase I)

  The Phase I portion of this study is to determine the Maximum Tolerated Dose (MTD) of combining OSI-774 with the paclitaxel-carboplatin chemoradiation protocol and to assess the safety and feasiblity of this combination.

  2 weeks after surgery

• Tolerability of Long-term OSI-774 (Phase II)

  Number of patients who experienced grade \>/= 3 toxicities on maintanance erolotinib (OSI-774)

  2 years

Secondary Outcomes (5)

• Pathological Complete Response Rate

  2 years

• Overall Survival

  3 years

• Progression Free Survival (PFS)

  3 years

• Locoregional Control

  2 years

• Distant Control

  2 years

Study Arms (3)

Dose Level A

EXPERIMENTAL

Erlotinib, Paclitaxel, and Carboplatin with Radiation Dose Level A: 50 mg OSI-774/50 mg/m2 Paclitaxel/2 AUC Carboplatin

Drug: carboplatin; Drug: Erlotinib; Drug: paclitaxel; Procedure: conventional surgery; Radiation: radiation therapy

Dose Level B

EXPERIMENTAL

Erlotinib, Paclitaxel, and Carboplatin with Radiation Dose Level B: 100 mg OSI-774/50 mg/m2 Paclitaxel/2 AUC Carboplatin

Drug: carboplatin; Drug: Erlotinib; Drug: paclitaxel; Procedure: conventional surgery; Radiation: radiation therapy

Dose Level C

EXPERIMENTAL

Erlotinib, Paclitaxel, and Carboplatin with Radiation Dose Level C: 150 mg OSI-774/50 mg/m2 Paclitaxel/2 AUC Carboplatin

Drug: carboplatin; Drug: Erlotinib; Drug: paclitaxel; Procedure: conventional surgery; Radiation: radiation therapy

Interventions

carboplatin DRUG

AUC2 weekly x 3 weeks

Also known as: Carbo

Dose Level A; Dose Level B; Dose Level C

Erlotinib DRUG

Daily

Also known as: OSI-774, Tarceva

Dose Level A; Dose Level B; Dose Level C

paclitaxel DRUG

50mg/m2/weekly x 3 weeks

Dose Level A; Dose Level B; Dose Level C

conventional surgery PROCEDURE

conventional surgery

Dose Level A; Dose Level B; Dose Level C

radiation therapy RADIATION

150 cGy bid

Dose Level A; Dose Level B; Dose Level C

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 * Surgically determined stage IIIA or IIIB disease * Histology from an involved mediastinal or supraclavicular lymph nodes alone will be allowed if a separate distal primary lesion is clearly evident on radiographs * Histological or cytological proof of mediastinal nodal involvement by mediastinoscopy, Chamberlain procedure, thoracoscopy, thoracotomy, or CT-guided biopsy is required except for cases of paralysis of left true vocal cord with separate left lung primary distinct from enlarged nodes \> 1 cm in the anterior-posterior window seen on the CT scan * Patients with N3 or T4 status must be evaluated and deemed potentially resectable after induction chemotherapy and radiation therapy * Measurable and evaluable disease * No malignant pleural effusion except for effusion visible only on CT scan and deemed too small to tap * No pericardial effusion * No small or mixed small cell/non-small cell lung cancer * No massive lesions requiring radiation to the entire lung * No metastatic cancer to the lungs PATIENT CHARACTERISTICS: * ECOG performance status 0-1 * WBC ≥ 3,000/mm\^3 * Platelet count \> 100,000/mm\^3 * Serum creatinine ≤ 2.0 mg/dL * Alkaline phosphatase, AST, and ALT \< 2 times upper limit of normal * Albumin \> 3.0 g/dL * Serum bilirubin \< 1.5 mg/dL * Adequate pulmonary function * No clinical evidence of another uncontrolled malignancy * No requirement for urgent therapy for severe local symptoms such as post-obstructive pneumonia PRIOR CONCURRENT THERAPY: * No prior chemotherapy, radiation therapy, or immunotherapy for lung cancer * No prior surgery to treat the cancer

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

Sponsors & Collaborators

• Nathan Pennell, MD, PhD: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center

Cleveland, Ohio, 44195, United States

Location

Related Links

• Clinical trial summary from the National Cancer Institute's PDQ® database

MeSH Terms

Conditions

Lung Neoplasms; Carcinoma, Non-Small-Cell Lung

Interventions

Carboplatin; Erlotinib Hydrochloride; Paclitaxel; Radiotherapy

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; Therapeutics

Limitations and Caveats

Some results were not assessible due to data not being collected.

Results Point of Contact

• Title: Dr. Nathan Pennell
• Organization: Case Comprehensive Cancer Center

penneln@ccf.org

21684459281

Study Officials

• Nathan Pennell, MD

  Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center

  STUDY CHAIR

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 16, 2006
• First Posted: January 18, 2006
• Study Start: October 1, 2005
• Primary Completion: February 1, 2011
• Study Completion: February 1, 2011
• Last Updated: July 20, 2020
• Results First Posted: July 20, 2020

Record last verified: 2020-07

Locations

US (1)