Ph II Adjuvant Carboplatin/Docetaxel in Curatively Resected Stage I-IIIA NSCLC

Completed · Phase 2

Conditions studied: Lung Cancer

In brief

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.

Key facts

Study ID

NCT00280735

Run by

UNC Lineberger Comprehensive Cancer Center

People needed

75

Starts

2004-05-01

Expected to finish

2011-07-01

Last updated by the study team

2017-07-11

Who can join

Age: 18 and older, up to 120. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• University of North Carolina Lineberger Comprehensive Cancer Center — Chapel Hill, North Carolina, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.