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

Phase 4

Completed

• Conditions: Non-small Cell Lung Cancer
• Interventions: Drug: Docetaxel-Carboplatin

• Registration Number: NCT00883675
• Lead Sponsor: Michael Mann

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.

Study Timeline

• Study First Submitted: 2009-04-17
• Study First Submitted QC: 2009-04-17
• Study First Posted: 2009-04-20
• Study Start: 2009-05
• Primary Completion: 2012-09
• Study Completion: 2012-12
• Status Verified: 2013-10
• Results First Submitted: 2013-10-29
• Results First Submitted QC: 2013-10-29
• Last Update Submitted: 2013-10-29
• Results First Posted: 2013-12-18
• Last Update Posted: 2013-12-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 133

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Treatment	Docetaxel-Carboplatin	Docetaxel: 75 mg/m2 over 1 hour every 3 weeks for 3 doses Carboplatin Area Under the Curve 5.5 over 0.5 to 1 hour every 3 weeks for 3 doses

Primary Outcome Measures

Name	Time	Method
Febrile Neutropenia	2 months	The primary endpoint of the study was safety, as reflected by a febrile neutropenia rate of \<10%.

Trial Locations

Locations (12)

Dartmouth-Hitchcock Medical Center; 🇺🇸 Lebanon, New Hampshire, United States

Xuanwu Hospital; 🇨🇳 Beijing, China

Beijing Youyi Hospital; 🇨🇳 Beijing, China

Sun Yat-sen Cancer Center; 🇨🇳 Guangzhou, China

Beijing Chaoyang Hospital; 🇨🇳 Beijing, China

Shanghai Lung Cancer Center, Shanghai Chest Hospital; 🇨🇳 Shanghai, China

Tianjin Cancer Center; 🇨🇳 Tianjin, China

Beijing Tumor Hospital; 🇨🇳 Beijing, China

China-Japan Friendship Hospital; 🇨🇳 Beijing, China

First Affiliated Hospital, Guangzhou Medical College; 🇨🇳 Guangzhou, China

Shanghai Chest Hopsital, Pulmonary Medicine; 🇨🇳 Shanghai, China

Shanghai Pulmonary Hospital; 🇨🇳 Shanghai, China