A Phase II Trial of Concurrent Docetaxel (Taxotere) / Carboplatin / Radiotherapy Followed by Surgical Resection Followed by Consolidation Taxotere / Carboplatin in Stage III Non-Small Cell Lung Cancer (NSCLC)
Overview
- Phase
- Phase 2
- Intervention
- Docetaxel
- Conditions
- Lung Cancer
- Sponsor
- Stanford University
- Enrollment
- 13
- Locations
- 1
- Primary Endpoint
- 2 Year Overall Survival After a Combination of Chemotherapy, Radiation and Surgery in Stage III NSCLC Patients Following the Protocol Therapy.
- Status
- Terminated
- Last Updated
- 10 years ago
Overview
Brief Summary
The purpose of this study is to assess how well this particular combination of chemotherapy, radiation and surgery works to help people with locally advanced lung cancer, how well PET scans indicates whether someone has responded to chemotherapy and radiation, and gene expression patterns related to outcomes in patients with locally advanced lung cancer who receive this treatment regimen.
Investigators
Heather Wakelee
Assistant Professor of Medicine
Stanford University
Eligibility Criteria
Inclusion Criteria
- •Histologically confirmed stage IIIA or IIIB NSCLC
- •Patients must have measurable disease
- •No previous chemotherapy, radiation therapy or other systemic therapy for their NSCLC.
- •Age\>18 years
- •Life expectancy \>12 months
- •ECOG performance status 0-1
- •Normal organ and marrow function
- •Medically fit for surgery at time of enrollment.
- •Women of childbearing potential and men must agree to use adequate contraception prior to study entry and for the duration of the study. Women must have a negative pregnancy test prior to enrollment.
- •Ability to understand and willingness to sign the consent form.
Exclusion Criteria
- •Previous chemotherapy, radiation therapy or any other systemic treatment for their NSCLC.
- •Patients receiving any other investigational agents.
- •Known metastatic disease (brain or any other site)
- •History of severe hypersensitivity reaction to docetaxel or other drugs formulated with polysorbate 80 or with allergic reactions to compounds of similar chemical composition to carboplatin or other agents used in the study.
- •Peripheral neuropathy \>grade 1
- •Uncontrolled concurrent illness
- •Pregnant women
- •Weight loss\>10% in the past 3 months before diagnosis.
- •Hyperglycemia - exclusion from PET analysis
- •HIV positive patients receiving combination anti-retroviral therapy because of possible pharmacokinetic interactions with docetaxel and carboplatin or other agents administered during the study.
Arms & Interventions
Chemotherapy+Radiation+Surgery
1. Concurrent weekly docetaxel at 20 mg/m2 and weekly carboplatin at an AUC of 2 with thoracic radiotherapy of 180-200cGy/day for 5/7 days to 45 Gy. 2. Complete surgical excision 3-6 weeks after completion of chemoradiotherapy. 3. No Surgery if patient is deemed unable to tolerate surgery, with completion to 61 Gy radiation 4. Consolidation after surgery: Docetaxel given at 75 mg/m2 every 3 weeks with carboplatin at AUC 6 every 3 weeks with concomitant growth factor support.
Intervention: Docetaxel
Chemotherapy+Radiation+Surgery
1. Concurrent weekly docetaxel at 20 mg/m2 and weekly carboplatin at an AUC of 2 with thoracic radiotherapy of 180-200cGy/day for 5/7 days to 45 Gy. 2. Complete surgical excision 3-6 weeks after completion of chemoradiotherapy. 3. No Surgery if patient is deemed unable to tolerate surgery, with completion to 61 Gy radiation 4. Consolidation after surgery: Docetaxel given at 75 mg/m2 every 3 weeks with carboplatin at AUC 6 every 3 weeks with concomitant growth factor support.
Intervention: Carboplatin
Chemotherapy+Radiation+Surgery
1. Concurrent weekly docetaxel at 20 mg/m2 and weekly carboplatin at an AUC of 2 with thoracic radiotherapy of 180-200cGy/day for 5/7 days to 45 Gy. 2. Complete surgical excision 3-6 weeks after completion of chemoradiotherapy. 3. No Surgery if patient is deemed unable to tolerate surgery, with completion to 61 Gy radiation 4. Consolidation after surgery: Docetaxel given at 75 mg/m2 every 3 weeks with carboplatin at AUC 6 every 3 weeks with concomitant growth factor support.
Intervention: Radiation therapy
Chemotherapy+Radiation+Surgery
1. Concurrent weekly docetaxel at 20 mg/m2 and weekly carboplatin at an AUC of 2 with thoracic radiotherapy of 180-200cGy/day for 5/7 days to 45 Gy. 2. Complete surgical excision 3-6 weeks after completion of chemoradiotherapy. 3. No Surgery if patient is deemed unable to tolerate surgery, with completion to 61 Gy radiation 4. Consolidation after surgery: Docetaxel given at 75 mg/m2 every 3 weeks with carboplatin at AUC 6 every 3 weeks with concomitant growth factor support.
Intervention: Surgical resection
Outcomes
Primary Outcomes
2 Year Overall Survival After a Combination of Chemotherapy, Radiation and Surgery in Stage III NSCLC Patients Following the Protocol Therapy.
Time Frame: Two years
Patients were analyzed for 2 year overall survival after receiving trimodality (chemotherapy/radiation/surgery) therapy for stage III NSCLC. Patients had a chest x-ray and a doctor visit with a physical examination every 3 months after completion of all therapy for 3 years then every 6 months for 3 years to look for evidence of recurrent disease and to follow survival. Thoracic computed tomography (CT) scans were obtained at 6, 12, 18 months after completion of all therapy and then yearly for 3 years or as clinically indicated to evaluate for relapse.
Secondary Outcomes
- Change in Standard Uptake Value (SUVmax) on Positron Emission Tomography (PET) Scans Pre and Post Chemotherapy and Radiation in This Trial and Ability to Predict Surgical Resection Rate, Progression-free Survival and 2 Year Overall Survival(baseline, 5 weeks after combined chemo-radiation)