NCT00883675

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
133

participants targeted

Target at P50-P75 for phase_4 nonsmall-cell-lung-cancer

Timeline
Completed

Started May 2009

Typical duration for phase_4 nonsmall-cell-lung-cancer

Geographic Reach
2 countries

12 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 17, 2009

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 20, 2009

Completed
11 days until next milestone

Study Start

First participant enrolled

May 1, 2009

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2012

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2012

Completed
1 year until next milestone

Results Posted

Study results publicly available

December 18, 2013

Completed
Last Updated

December 18, 2013

Status Verified

October 1, 2013

Enrollment Period

3.3 years

First QC Date

April 17, 2009

Results QC Date

October 29, 2013

Last Update Submit

October 29, 2013

Conditions

Non-small Cell Lung Cancer

Keywords

Lung cancerAdjuvant therapy

Outcome Measures

Primary Outcomes (1)

  • Febrile Neutropenia

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

    2 months

Study Arms (1)

Treatment

EXPERIMENTAL

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

Drug: Docetaxel-Carboplatin

Interventions

Docetaxel-CarboplatinDRUG

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

Also known as: Taxotere, Paraplatin
Treatment

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (12)

Dartmouth-Hitchcock Medical Center

Lebanon, New Hampshire, 03756, United States

Location

Beijing Chaoyang Hospital

Beijing, China

Location

Beijing Tumor Hospital

Beijing, China

Location

Beijing Youyi Hospital

Beijing, China

Location

China-Japan Friendship Hospital

Beijing, China

Location

Xuanwu Hospital

Beijing, China

Location

First Affiliated Hospital, Guangzhou Medical College

Guangzhou, China

Location

Sun Yat-sen Cancer Center

Guangzhou, China

Location

Shanghai Chest Hopsital, Pulmonary Medicine

Shanghai, China

Location

Shanghai Lung Cancer Center, Shanghai Chest Hospital

Shanghai, China

Location

Shanghai Pulmonary Hospital

Shanghai, China

Location

Tianjin Cancer Center

Tianjin, China

Location

Related Publications (1)

  • 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.

    PMID: 24255769DERIVED

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell LungLung Neoplasms

Interventions

DocetaxelCarboplatin

Condition Hierarchy (Ancestors)

Carcinoma, BronchogenicBronchial NeoplasmsRespiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

TaxoidsCyclodecanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsDiterpenesTerpenesCoordination Complexes

Results Point of Contact

Title
Michael Mann, MD
Organization
Maestro
michael.mann@ucsfmedctr.org
650-380-9579

Study Officials

  • David Jablons, MD

    Maestro Clinical

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
GT60
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
NETWORK
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Director

Study Record Dates

First Submitted

April 17, 2009

First Posted

April 20, 2009

Study Start

May 1, 2009

Primary Completion

September 1, 2012

Study Completion

December 1, 2012

Last Updated

December 18, 2013

Results First Posted

December 18, 2013

Record last verified: 2013-10

Locations

CN(11)US(1)