Carboplatin and Docetaxel After Surgery in Treating Patients With Stage I, Stage II, or Stage III Non-Small Cell Lung Cancer

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
UNC Lineberger Comprehensive Cancer Center
ClinicalTrials.gov Identifier:
NCT00280735
First received: January 19, 2006
Last updated: September 18, 2012
Last verified: September 2012
  Purpose

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.


Condition Intervention Phase
Lung Cancer
Drug: carboplatin
Drug: docetaxel
Procedure: adjuvant therapy
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase II Trial Exploring the Feasibility of Adjuvant Carboplatin/Docetaxel in Curatively Resected Stage I-IIIA Non-Small Cell Lung Cancer

Resource links provided by NLM:


Further study details as provided by UNC Lineberger Comprehensive Cancer Center:

Primary Outcome Measures:
  • Feasibility of administering of carboplatin/docetaxel as adjuvant therapy in resected stage I-IIIA NSCLC [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Number of subjects with toxicity [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
    Assess the number of subjects experiencing toxicities(per the CTCAE criteria) after receiving carboplatin/docetaxel in the adjuvant setting


Enrollment: 75
Study Start Date: May 2004
Primary Completion Date: July 2011 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: carboplatin
    Carboplatin will be given intravenously,once,every 3 weeks. The carboplatin AUC dose will be calculated using the Calvert Equation 19 as follows: Carboplatin dose (mg) = 6x (GFR + 25)
    Drug: docetaxel
    75 mg/m² intravenously, once, every 3 weeks
    Other Name: Taxotere
    Procedure: adjuvant therapy
    Adjuvant therapy with carboplatin and docetaxel will begin within 8 weeks of surgical resection
Detailed Description:

OBJECTIVES:

Primary

  • Evaluate the feasibility of adjuvant carboplatin and docetaxel in patients with resected stage I, II, or IIIA non-small cell lung cancer.

Secondary

  • Determine the toxicity of this regimen in these patients.
  • Determine the survival patterns of patients treated with this regimen.
  • Assess the patterns of recurrence in patients treated with this regimen.

OUTLINE: Patients receive carboplatin IV on day 1 and docetaxel IV on day 1. Treatment repeats every 3 weeks for 4 courses in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed every 3 months for 2 years and then every 6 months for 3 years.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

Inclusion criteria:

  • 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:

  • 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), AST, and 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
  • Negative pregnancy test
  • Fertile patients must use effective contraception during and for at least 3 months after study therapy
  • No breastfeeding
  • No peripheral neuropathy ≥ grade 2
  • No history of severe hypersensitivity to docetaxel or polysorbate 80
  • Prior history of malignancy allowed provided the attending medical oncologists believes that adjuvant chemotherapy is indicated and will potentially benefit the patient

PRIOR CONCURRENT THERAPY:

  • 2-8 weeks since prior surgery and recovered
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00280735

Locations
United States, North Carolina
University of North Carolina Lineberger Comprehensive Cancer Center
Chapel Hill, North Carolina, United States, 27599
Sponsors and Collaborators
UNC Lineberger Comprehensive Cancer Center
Investigators
Principal Investigator: Mark A. Socinski, MD UNC Lineberger Comprehensive Cancer Center
  More Information

Additional Information:
Publications:
Responsible Party: UNC Lineberger Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT00280735     History of Changes
Other Study ID Numbers: LCCC 0320, CDR0000561625
Study First Received: January 19, 2006
Last Updated: September 18, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by UNC Lineberger Comprehensive Cancer Center:
stage I non-small cell lung cancer
stage III non-small cell lung cancer
stage IIIA non-small cell lung cancer

Additional relevant MeSH terms:
Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Bronchial Neoplasms
Carcinoma, Bronchogenic
Lung Diseases
Neoplasms
Neoplasms by Site
Respiratory Tract Diseases
Respiratory Tract Neoplasms
Thoracic Neoplasms
Carboplatin
Docetaxel
Antimitotic Agents
Antineoplastic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses
Tubulin Modulators

ClinicalTrials.gov processed this record on October 23, 2014