Ph II Adjuvant Carboplatin/Docetaxel in Curatively Resected Stage I-IIIA NSCLC
Phase II Trial Exploring the Feasibility of Adjuvant Carboplatin/Docetaxel in Curatively Resected Stage I-IIIA Non-Small Cell Lung Cancer
1 other identifier
interventional
75
1 country
1
Brief Summary
RATIONALE: Drugs used in chemotherapy, such as carboplatin and docetaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving carboplatin together with docetaxel after surgery may kill any tumor cells that remain after surgery. PURPOSE: This phase II trial is studying how well giving carboplatin together with docetaxel works in treating patients with stage I, stage II, or stage III non-small cell lung cancer.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2 lung-cancer
Started May 2004
Longer than P75 for phase_2 lung-cancer
1 active site
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
Study Start
First participant enrolled
May 1, 2004
CompletedFirst Submitted
Initial submission to the registry
January 19, 2006
CompletedFirst Posted
Study publicly available on registry
January 23, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2011
CompletedResults Posted
Study results publicly available
June 12, 2017
CompletedJuly 11, 2017
June 1, 2017
7.2 years
January 19, 2006
March 24, 2017
June 9, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Number of Participants Who Completed Four Cycles of the Carboplatin/Docetaxel Regimen
Feasibility was based on the percentage of patients completing four cycles of the carboplatin/docetaxel regimen to a high fraction of patients with curatively resected stage IIIIA non-small cell lung cancer within 12 weeks.
12 weeks from initiating adjuvant therapy
Secondary Outcomes (4)
Patterns of Recurrence in Patients Treated With This Regimen
Up to 5 years
Toxicity in Patients Treated With This Regimen
Day 1 of treatment to 30 days after treatment discontinuation
Progression Free Survival
The time between the start of treatment to disease progression or death or the date of last contact, measured up to 18 months
Overall Survival
The time between the start of treatment to disease progression or death or the date of last contact, measured up to 18 months
Study Arms (1)
Single Arm Trial
OTHERadjuvant carboplatin plus docetaxel carboplatin area under curve (AUC) = 6 IV on day 1 every 3 weeks for 4 cycles docetaxel 75 mg/m² IV on day 1 every 3 weeks for 4 cycles
Interventions
Carboplatin will be given intravenously,once,every 3 weeks. The carboplatin area under curve (AUC) dose will be calculated using the Calvert Equation 19 as follows: Carboplatin dose (mg) = 6x (GFR + 25)
Eligibility Criteria
You may qualify if:
- Histologically confirmed non-small cell lung cancer
- Stage I-IIIA disease
- Must have undergone a complete resection
- Must begin adjuvant chemotherapy within 8 weeks of surgical resection
- PATIENT CHARACTERISTICS:
- Eastern Cooperative Oncology Group (ECOG) performance status 0-1
- Absolute neutrophil count ≥ 1,500/mm\^3
- Hemoglobin ≥ 8.0 g/dL
- Platelet count ≥ 100,000/mm\^3
- Serum creatinine normal OR creatinine clearance ≥ 40 mL/min
- Bilirubin normal
- Alkaline phosphatase (AP), Aspartate aminotransferase (AST), and Alanine transaminase (ALT) must meet 1 of the following criteria:
- AP normal AND AST and ALT ≤ 5 times upper limit of normal (ULN)
- AP ≤ 2.5 times ULN AND AST and ALT ≤ 1.5 times ULN
- AP ≤ 5 times ULN AND AST and ALT normal
- +2 more criteria
You may not qualify if:
- Patients with a history of severe hypersensitivity to docetaxel or polysorbate 80 are excluded.
- Women who are currently or planning to breast feed.
- Those with peripheral neuropathy ≥ grade 2
- PRIOR CONCURRENT THERAPY:
- weeks since prior surgery and recovered
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of North Carolina Lineberger Comprehensive Cancer Center
Chapel Hill, North Carolina, 27599, United States
Related Publications (1)
Stinchcombe TE, Harper HD, Hensing TA, Moore DT, Crane JM, Atkins JN, Willard EM, Detterbeck FC, Socinski MA. The feasibility of adjuvant carboplatin and docetaxel in patients with curatively resected non-small cell lung cancer. J Thorac Oncol. 2008 Feb;3(2):145-51. doi: 10.1097/JTO.0b013e318160c5f1.
PMID: 18303435RESULT
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Robin V. Johnson
- Organization
- UNC Lineberger Comprehensive Cancer
Study Officials
- PRINCIPAL INVESTIGATOR
Mark A. Socinski, MD
Florida Hospital Cancer Institute
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- GT60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 19, 2006
First Posted
January 23, 2006
Study Start
May 1, 2004
Primary Completion
July 1, 2011
Study Completion
July 1, 2011
Last Updated
July 11, 2017
Results First Posted
June 12, 2017
Record last verified: 2017-06
Data Sharing
- IPD Sharing
- Will not share