Clinical trial NCT00883675: Safety Study of Adjuvant Docetaxel-Carboplatin Treatment for Resected Lung Cancer
Official title: Multicenter Exploratory Trial of the Safety and Efficacy of Adjuvant Docetaxel and Carboplatin in Patients With Resected Non-small Cell Lung Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Non-small Cell Lung Cancer
Keywords: Lung cancer
Adjuvant therapy
Lead sponsor: Maestro Clinical, Inc.
Sponsor class: NETWORK
Collaborators: name: Sanofi
First posted: 2009-04-20
Enrollment: 133
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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 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.

Eligibility criteria: 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

Primary outcomes:
measure: Febrile Neutropenia
timeFrame: 2 months
Secondary outcomes:
Other outcomes:
Locations:
city: Lebanon
country: United States
facility: Dartmouth-Hitchcock Medical Center
state: New Hampshire
city: Beijing
country: China
facility: Beijing Chaoyang Hospital
city: Beijing
country: China
facility: Beijing Tumor Hospital
city: Beijing
country: China
facility: Beijing Youyi Hospital
city: Beijing
country: China
facility: China-Japan Friendship Hospital
city: Beijing
country: China
facility: Xuanwu Hospital
city: Guangzhou
country: China
facility: First Affiliated Hospital, Guangzhou Medical College
city: Guangzhou
country: China
facility: Sun Yat-sen Cancer Center
city: Shanghai
country: China
facility: Shanghai Chest Hopsital, Pulmonary Medicine
city: Shanghai
country: China
facility: Shanghai Lung Cancer Center, Shanghai Chest Hospital
city: Shanghai
country: China
facility: Shanghai Pulmonary Hospital
city: Tianjin
country: China
facility: Tianjin Cancer Center
Study officials:
affiliation: Maestro Clinical
name: David Jablons, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Zhi X, Gao W, Han B, Yang Y, Li H, Liu D, Wang C, Min G, Long H, Rigas JR, Carey M, Jahan T, Sammann A, Reza J, Wang D, Mann MJ, Jablons DM, He J; China Clinical Trials Consortium. VATS lobectomy facilitates the delivery of adjuvant docetaxel-carboplatin chemotherapy in patients with non-small cell lung cancer. J Thorac Dis. 2013 Oct;5(5):578-84. doi: 10.3978/j.issn.2072-1439.2012.02.05.