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Completed

NCT Number: NCT00883675

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

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.

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Key information

Conditions

Non-small Cell Lung Cancer Bronchial Neoplasms Carcinoma, Bronchogenic Carcinoma, Non-Small-Cell Lung Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Beijing Chaoyang Hospital, Beijing, China

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Docetaxel-Carboplatin

Drug

Docetaxel: 75 mg/m2 over 1 hour every 3 weeks for 3 doses Carboplatin AUC 5.5 over 0.5 to 1 hour every 3 weeks for 3 doses

Other names: Taxotere, Paraplatin

Primary outcomes

  1. Febrile Neutropenia

    Time frame: 2 months

    The primary endpoint of the study was safety, as reflected by a febrile neutropenia rate of <10%.

Sponsors and collaborators

Lead sponsor

Michael Mann

Network

Collaborators

  • Sanofi

Registry information

Official study title

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

Important dates

Study start
2009
Primary completion
2012
Study completion
2012
First posted
Apr 20, 2009
Registry last updated
Dec 18, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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