Ph II Adjuvant Carboplatin/Docetaxel in Curatively Resected Stage I-IIIA NSCLC
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.
Checked against the public recordLast updated Jul 11, 2017 · Source: ClinicalTrials.gov
What this study is about
- Purpose
- Treatment
- Study type
- Interventional
- Phase
- Phase 2
- Sponsor
- UNC Lineberger Comprehensive Cancer Center
- Interventions being studied
- Drug: carboplatin; Drug: docetaxel
How this study is categorized
These labels come from structured fields and exact terms in the public record.
Who may be able to participate
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
Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.
U.S. locations
- University of North Carolina Lineberger Comprehensive Cancer CenterChapel Hill, North Carolina
Source and freshness
Processed from ClinicalTrials.gov. Last public update: Jul 11, 2017. Always confirm current availability with the study team.