Safety Study of Adjuvant Docetaxel-Carboplatin Treatment for Resected Lung Cancer
This study has been completed.
Sponsor:
Michael Mann
Collaborator:
Sanofi
Information provided by (Responsible Party):
Michael Mann, Maestro Clinical, Inc.
ClinicalTrials.gov Identifier:
NCT00883675
First received: April 17, 2009
Last updated: January 25, 2013
Last verified: January 2013
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Non-small Cell Lung Cancer |
Drug: Docetaxel-Carboplatin |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Multicenter Exploratory Trial of the Safety and Efficacy of Adjuvant Docetaxel and Carboplatin in Patients With Resected Non-small Cell Lung Cancer |
Resource links provided by NLM:
Further study details as provided by Maestro Clinical, Inc.:
Primary Outcome Measures:
- Febrile neutropenia [ Time Frame: 2 months ] [ Designated as safety issue: Yes ]
| Enrollment: | 133 |
| Study Start Date: | May 2009 |
| Study Completion Date: | December 2012 |
| Primary Completion Date: | September 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Treatment |
Drug: Docetaxel-Carboplatin
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 Name: Taxotere, Paraplatin
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00883675
Locations
| United States, New Hampshire | |
| Dartmouth-Hitchcock Medical Center | |
| Lebanon, New Hampshire, United States, 03756 | |
| China | |
| Xuanwu Hospital | |
| Beijing, China | |
| Beijing Chaoyang Hospital | |
| Beijing, China | |
| Beijing Youyi Hospital | |
| Beijing, China | |
| Beijing Tumor Hospital | |
| Beijing, China | |
| China-Japan Friendship Hospital | |
| Beijing, China | |
| Sun Yat-sen Cancer Center | |
| Guangzhou, China | |
| First Affiliated Hospital, Guangzhou Medical College | |
| Guangzhou, China | |
| Shanghai Chest Hopsital, Pulmonary Medicine | |
| Shanghai, China | |
| Shanghai Lung Cancer Center, Shanghai Chest Hospital | |
| Shanghai, China | |
| Shanghai Pulmonary Hospital | |
| Shanghai, China | |
| Tianjin Cancer Center | |
| Tianjin, China | |
Sponsors and Collaborators
Michael Mann
Sanofi
Investigators
| Principal Investigator: | David Jablons, MD | Maestro Clinical |
More Information
No publications provided
| Responsible Party: | Michael Mann, Director, Maestro Clinical, Inc. |
| ClinicalTrials.gov Identifier: | NCT00883675 History of Changes |
| Other Study ID Numbers: | MC#08-002, IIT 12230 |
| Study First Received: | April 17, 2009 |
| Last Updated: | January 25, 2013 |
| Health Authority: | United States: Institutional Review Board China: Ethics Committee |
Keywords provided by Maestro Clinical, Inc.:
|
Lung cancer Adjuvant therapy |
Additional relevant MeSH terms:
|
Carcinoma, Non-Small-Cell Lung Lung Neoplasms Carcinoma, Bronchogenic Bronchial Neoplasms Respiratory Tract Neoplasms Thoracic Neoplasms Neoplasms by Site Neoplasms Lung Diseases |
Respiratory Tract Diseases Adjuvants, Immunologic Docetaxel Carboplatin Immunologic Factors Physiological Effects of Drugs Pharmacologic Actions Antineoplastic Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on May 22, 2013