Ph II Adjuvant Carboplatin/Docetaxel in Curatively Resected Stage I-IIIA NSCLC

NCT00280735 | Completed Phase 2 Results DMC

• 1 other identifier: LCCC 0320
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 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.

Conditions

Lung Cancer

Keywords

stage I non-small cell lung cancer; stage II non-small cell lung cancer; stage IIIA non-small cell lung cancer

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

OTHER

adjuvant 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

Drug: carboplatin; Drug: docetaxel

Interventions

carboplatin DRUG

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)

Also known as: paraplatin

Single Arm Trial

docetaxel DRUG

75 mg/m² intravenously, once, every 3 weeks

Also known as: Taxotere

Single Arm Trial

Eligibility Criteria

• Age: 18 Years - 120 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

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

Sponsors & Collaborators

• UNC Lineberger Comprehensive Cancer Center: lead
• Aventis Pharmaceuticals: collaborator

Study Sites (1)

University of North Carolina Lineberger Comprehensive Cancer Center

Chapel Hill, North Carolina, 27599, United States

Location

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: 18303435 RESULT

Related Links

• UNC Lineberger Comprehensive Cancer Center

MeSH Terms

Conditions

Lung Neoplasms; Carcinoma, Non-Small-Cell Lung

Interventions

Carboplatin; Docetaxel

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Carcinoma, Bronchogenic; Bronchial Neoplasms

Intervention Hierarchy (Ancestors)

Coordination Complexes; Organic Chemicals; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Diterpenes; Terpenes

Results Point of Contact

• Title: Robin V. Johnson
• Organization: UNC Lineberger Comprehensive Cancer

Robin_V_Johnson@med.unc.edu

919-966-1125

Study Officials

• Mark A. Socinski, MD

  Florida Hospital Cancer Institute

  PRINCIPAL INVESTIGATOR

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

Locations

US (1)