Phase II Docetaxel / Carboplatin / XRT + Surgical Resection in Stage III NSCLC

Stanford University

Status and phase: Terminated; Phase 2

Conditions: Carcinoma, Non-Small-Cell Lung; Lung Cancer

Treatments: Procedure: Radiation therapy; Drug: Carboplatin; Procedure: Surgical resection; Drug: Docetaxel

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00238615

GIA #12169 (Other Identifier)

11804

LUN0002

78999 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 13 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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13 participants in 1 patient group

Chemotherapy+Radiation+Surgery

Experimental group

Description:

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.

Treatment:

Drug: Docetaxel

Procedure: Surgical resection

Drug: Carboplatin

Procedure: Radiation therapy