Status:
COMPLETED
Safety Study of Adjuvant Docetaxel-Carboplatin Treatment for Resected Lung Cancer
Lead Sponsor:
Michael Mann
Collaborating Sponsors:
Sanofi
Conditions:
Non-small Cell Lung Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
The purpose of this study is to determine whether it is safe to treat lung cancer patients who have undergone an attempt at curative resection with the combination of docetaxel and carboplatin.
Detailed Description
Patients with stage Ib - IIIa NSCLC participated in an open-label, single arm study to assess the safety and tolerability of docetaxel (75 mg/kg) and carboplatin (AUC 5.5) administered for 3 cycles af...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2012
Estimated Enrollment :
133 Patients enrolled
Trial Details
Trial ID
NCT00883675
Start Date
May 1 2009
End Date
December 1 2012
Last Update
December 18 2013
Active Locations (12)
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1
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, United States, 03756
2
Beijing Chaoyang Hospital
Beijing, China
3
Beijing Tumor Hospital
Beijing, China
4
Beijing Youyi Hospital
Beijing, China