Trial Search Results

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

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.

Stanford is currently not accepting patients for this trial.

Lead Sponsor:

Stanford University

Collaborator: Aventis Pharmaceuticals

Intervention(s):

  • Drug: Docetaxel
  • Drug: Carboplatin
  • Procedure: Radiation therapy
  • Procedure: Surgical resection

Phase:

Phase 2

Eligibility


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.

Ages Eligible for Study

18 Years - N/A

Genders Eligible for Study

All

Not currently accepting new patients for this trial

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Lisa Zhou
6507364112
Not Recruiting