Carboplatin and Docetaxel After Surgery in Treating Patients With Stage I, Stage II, or Stage III Non-Small Cell Lung Cancer (NRR)
This study has been completed.
Sponsor:
UNC Lineberger Comprehensive Cancer Center
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
UNC Lineberger Comprehensive Cancer Center
ClinicalTrials.gov Identifier:
NCT00280735
First received: January 19, 2006
Last updated: January 20, 2016
Last verified: January 2016
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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) |
| Arms | Assigned Interventions |
|---|---|
|
Single Arm Trial
Single Arm Trial
|
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 to 120 Years (Adult, Senior) |
| 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
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
National Cancer Institute (NCI)
Investigators
| Principal Investigator: | Mark A. Socinski, MD | UNC Lineberger Comprehensive Cancer Center |
More 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: | January 20, 2016 |
| 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:
|
Lung Neoplasms Carcinoma, Non-Small-Cell Lung Respiratory Tract Neoplasms Thoracic Neoplasms Neoplasms by Site Neoplasms Lung Diseases Respiratory Tract Diseases Carcinoma, Bronchogenic |
Bronchial Neoplasms Docetaxel Carboplatin Antineoplastic Agents Tubulin Modulators Antimitotic Agents Mitosis Modulators Molecular Mechanisms of Pharmacological Action |
ClinicalTrials.gov processed this record on September 29, 2016