Erlotinib, Paclitaxel, and Carboplatin Combined With Radiation Therapy for Stage III Non-Small Cell Lung Cancer
This study is ongoing, but not recruiting participants.
Sponsor:
Case Comprehensive Cancer Center
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
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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
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 May 16, 2013