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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)


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Lung Cancer, Carcinoma, Non-Small-Cell Lung

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Trial Information

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)


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.

Type of Study:

Interventional

Study Design:

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Efficacy of PET scans in indicating whether someone has responded to chemotherapy and radiation

Outcome Time Frame:

Study subject's tumor size will be evaluate by PET scan after 5 weeks of concurrent chemo and radiation treatment.

Safety Issue:

No

Principal Investigator

Heather A. Wakelee

Investigator Role:

Principal Investigator

Investigator Affiliation:

Stanford University

Authority:

United States: Food and Drug Administration

Study ID:

LUN0002

NCT ID:

NCT00238615

Start Date:

March 2003

Completion Date:

August 2014

Related Keywords:

  • Lung Cancer
  • Carcinoma, Non-Small-Cell Lung
  • Carcinoma
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms

Name

Location

Stanford University School of MedicineStanford, California  94305-5317