Safety Study of Adjuvant Docetaxel-Carboplatin Treatment for Resected Lung Cancer

Michael Mann

Status and phase

Completed

Phase 4

Conditions

Non-small Cell Lung Cancer

Treatments

Drug: Docetaxel-Carboplatin

Study type

Interventional

Funder types

NETWORK

Industry

Identifiers

NCT00883675

MC#08-002

IIT 12230

Details and patient eligibility

About

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.

Full 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 after resection for curative intent. The primary endpoint of the study was safety, as reflected by a febrile neutropenia rate of <10%. Other endpoints assessed protocol compliance and the impact of minimally invasive surgical technique.

Enrollment

133 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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