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Multicenter Exploratory Trial of the Safety and Efficacy of Adjuvant Docetaxel and Carboplatin in Patients With Resected Non-small Cell Lung Cancer


Phase 4
18 Years
N/A
Not Enrolling
Both
Non-small Cell Lung Cancer

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Trial Information

Multicenter Exploratory Trial of the Safety and Efficacy of Adjuvant Docetaxel and Carboplatin in Patients With Resected Non-small Cell Lung Cancer


Inclusion Criteria:



- Non-small cell lung cancer stage IB - IIIA, complete resection with mediastinal lymph
node dissection

- ECOG status 0-1

- >14 and <56 days since resection

Exclusion Criteria:

- Prior chemotherapy and/or radiation therapy for lung cancer

- Peripheral neuropathy > grade 1

- Concurrent other malignancies, other than basal cell or squamous cell carcinoma of
the skin or carcinoma in situ of the cervix

- Medical condition that will not permit treatment or follow up according to the
protocol

- Prior treatment with docetaxel or carboplatin

- Hypersensitivity to polysorbate 80, platinum-containing compounds or mannitol

- Treatment with other investigational anti-cancer drugs within 30 days of registration

- Pregnant or nursing women

- HIV-positive patients

Type of Study:

Interventional

Study Design:

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Febrile neutropenia

Outcome Time Frame:

2 months

Safety Issue:

Yes

Principal Investigator

David Jablons, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Maestro Clinical

Authority:

United States: Institutional Review Board

Study ID:

MC#08-002

NCT ID:

NCT00883675

Start Date:

May 2009

Completion Date:

December 2012

Related Keywords:

  • Non-Small Cell Lung Cancer
  • Lung cancer
  • Adjuvant therapy
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms

Name

Location

Dartmouth-Hitchcock Medical CenterLebanon, New Hampshire  03756