Ph II Adjuvant Carboplatin/Docetaxel in Curatively Resected Stage I-IIIA NSCLC
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| ClinicalTrials.gov Identifier: NCT00280735 |
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Recruitment Status :
Completed
First Posted : January 23, 2006
Results First Posted : June 12, 2017
Last Update Posted : July 11, 2017
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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 or disease | Intervention/treatment | Phase |
|---|---|---|
| Lung Cancer | Drug: carboplatin Drug: docetaxel | Phase 2 |
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.
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 75 participants |
| Intervention Model: | Single Group Assignment |
| Masking: | None (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 |
| Actual Study Start Date : | May 2004 |
| Actual Primary Completion Date : | July 2011 |
| Actual Study Completion Date : | July 2011 |
| Arm | Intervention/treatment |
|---|---|
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Single Arm Trial
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
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Drug: carboplatin
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)
Other Name: paraplatin Drug: docetaxel 75 mg/m² intravenously, once, every 3 weeks
Other Name: Taxotere |
- Number of Participants Who Completed Four Cycles of the Carboplatin/Docetaxel Regimen [ Time Frame: 12 weeks from initiating adjuvant therapy ]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.
- Patterns of Recurrence in Patients Treated With This Regimen [ Time Frame: Up to 5 years ]Patterns were assessed with a staging chest computerized tomography (CT), bone or positron emission tomography (PET) scan and brain magnetic resonance imaging (MRI)/CT scan at recurrence.
- Toxicity in Patients Treated With This Regimen [ Time Frame: Day 1 of treatment to 30 days after treatment discontinuation ]Safety determinations are based on the rate of drug-related adverse events (AEs) reported based upon the toxicity as measured by the NCI Common Terminology Criteria for Adverse Events version 3.0 (CTCAE v3.0).
- Progression Free Survival [ Time Frame: The time between the start of treatment to disease progression or death or the date of last contact, measured up to 18 months ]Relapse-free survival rate at 18 months. Patients were determined to have progression either by radiographic and/or pathological assessment by local physician per local standard of care monitoring for disease recurrence.
- Overall Survival [ Time Frame: 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 rate at 18 months.
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| Ages Eligible for Study: | 18 Years to 120 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Inclusion criteria:
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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
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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
- Negative pregnancy test
- Fertile patients must use effective contraception during and for at least 3 months after study therapy
Exclusion criteria:
- 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:
- 2-8 weeks since prior surgery and recovered
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00280735
| United States, North Carolina | |
| University of North Carolina Lineberger Comprehensive Cancer Center | |
| Chapel Hill, North Carolina, United States, 27599 | |
| Principal Investigator: | Mark A. Socinski, MD | Florida Hospital Cancer Institute |
Additional Information:
Publications of Results:
| Responsible Party: | UNC Lineberger Comprehensive Cancer Center |
| ClinicalTrials.gov Identifier: | NCT00280735 History of Changes |
| Other Study ID Numbers: |
LCCC 0320 |
| First Posted: | January 23, 2006 Key Record Dates |
| Results First Posted: | June 12, 2017 |
| Last Update Posted: | July 11, 2017 |
| Last Verified: | June 2017 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
Keywords provided by UNC Lineberger Comprehensive Cancer Center:
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stage I non-small cell lung cancer stage II non-small cell lung cancer stage IIIA non-small cell lung cancer |
Additional relevant MeSH terms:
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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 |