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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2012 by Case Comprehensive Cancer Center.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Case Comprehensive Cancer Center
ClinicalTrials.gov Identifier:
NCT00278148
First received: January 16, 2006
Last updated: February 8, 2012
Last verified: February 2012
  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 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.


Condition Intervention Phase
Lung Cancer
Drug: carboplatin
Drug: Tarceva
Drug: paclitaxel
Procedure: conventional surgery
Radiation: radiation therapy
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase I/II Trial of Neoadjuvant Paclitaxel, Carboplatin and OSI-774 (Tarceva) With Concurrent Accelerated Hyperfractionation Radiation Followed by Maintenance Therapy With OSI-774 for Stage III Non-Small Cell Lung Cancer

Resource links provided by NLM:


Further study details as provided by Case Comprehensive Cancer Center:

Primary Outcome Measures:
  • Maximum tolerated dose of erlotinib hydrochloride (Phase I) [ Time Frame: 2 weeks after surgery ] [ Designated as safety issue: Yes ]
    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.

  • Tolerability of long-term OSI-774 (Phase II) [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
    Number and percentages of patients with each type of toxicity summarized with 95% confidence intervals


Secondary Outcome Measures:
  • Clinical and pathological response rate [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    Overall objective response rate (complete response [CR] and partial response [PR])using the RECIST criteria

  • Overall survival [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    Estimated by the Kaplan-Meier method and summarized at various follow-up points as the number of patients remaining at risk, the event estimate, standard error, and median.From the date of study entry to the date of the corresponding event (recurrence of death) or the date of final follow-up, assessed up to 2 years

  • Disease-specific survival [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    Estimated by the Kaplan-Meier method and summarized at various follow-up points as the number of patients remaining at risk, the event estimate, standard error, and median.From the date of study entry to the date of the corresponding event (recurrence of death) or the date of final follow-up, assessed up to 2 years

  • Locoregional control [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    Estimated by the Kaplan-Meier method and summarized at various follow-up points as the number of patients remaining at risk, the event estimate, standard error, and median.From the date of study entry to the date of the corresponding event (recurrence of death) or the date of final follow-up, assessed up to 2 years

  • Distant control [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    Estimated by the Kaplan-Meier method and summarized at various follow-up points as the number of patients remaining at risk, the event estimate, standard error, and median.From the date of study entry to the date of the corresponding event (recurrence of death) or the date of final follow-up, assessed up to 2 years


Enrollment: 32
Study Start Date: October 2005
Estimated Study Completion Date: December 2012
Primary Completion Date: February 2011 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: carboplatin
    AUC2 weekly x 3 weeks
    Other Name: Carbo
    Drug: Tarceva
    Daily
    Other Name: OSI-774
    Drug: paclitaxel
    50mg/m2/weekly x 3 weeks
    Other Name: paclitaxel
    Procedure: conventional surgery
    conventional surgery
    Other Name: conventional surgery
    Radiation: radiation therapy
    150 cGy bid
    Other Name: radiation therapy
  Show Detailed Description

  Eligibility

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

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00278148

Locations
United States, Ohio
Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center
Cleveland, Ohio, United States, 44195
Sponsors and Collaborators
Case Comprehensive Cancer Center
Investigators
Study Chair: Nathan Pennell, MD Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: Case Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT00278148     History of Changes
Other Study ID Numbers: CCF5876, P30CA043703, CCF-5876
Study First Received: January 16, 2006
Last Updated: February 8, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Case Comprehensive Cancer Center:
stage IIIA non-small cell lung cancer
stage IIIB non-small cell lung cancer

Additional relevant MeSH terms:
Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Carcinoma, Bronchogenic
Bronchial Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
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 July 20, 2014