- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT00280735
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
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.
Studieöversikt
Status
Betingelser
Intervention / Behandling
Detaljerad beskrivning
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.
Studietyp
Inskrivning (Faktisk)
Fas
- Fas 2
Kontakter och platser
Studieorter
-
-
North Carolina
-
Chapel Hill, North Carolina, Förenta staterna, 27599
- University of North Carolina Lineberger Comprehensive Cancer Center
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
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:
- 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
- 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
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: N/A
- Interventionsmodell: Enskild gruppuppgift
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
---|---|
Övrig: 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
|
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)
Andra namn:
75 mg/m² intravenously, once, every 3 weeks
Andra namn:
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
Number of Participants Who Completed Four Cycles of the Carboplatin/Docetaxel Regimen
Tidsram: 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.
|
12 weeks from initiating adjuvant therapy
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
Patterns of Recurrence in Patients Treated With This Regimen
Tidsram: 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.
|
Up to 5 years
|
Toxicity in Patients Treated With This Regimen
Tidsram: 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).
|
Day 1 of treatment to 30 days after treatment discontinuation
|
Progression Free Survival
Tidsram: 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.
|
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
Tidsram: 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.
|
The time between the start of treatment to disease progression or death or the date of last contact, measured up to 18 months
|
Samarbetspartners och utredare
Samarbetspartners
Utredare
- Huvudutredare: Mark A. Socinski, MD, Florida Hospital Cancer Institute
Publikationer och användbara länkar
Användbara länkar
Studieavstämningsdatum
Studera stora datum
Studiestart (Faktisk)
Primärt slutförande (Faktisk)
Avslutad studie (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Uppskatta)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- LCCC 0320
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
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