This trial is active, not recruiting.

Condition lung cancer
Treatments cisplatin, docetaxel, adjuvant therapy
Phase phase 2
Sponsor Sidney Kimmel Comprehensive Cancer Center
Collaborator National Cancer Institute (NCI)
Start date August 2004
Trial size 50 participants
Trial identifier NCT00281970, CDR0000455112, JHOC-J0435, JHOC-WIRB-20040761, MSKCC-04039


RATIONALE: Drugs used in chemotherapy, such as docetaxel and cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving chemotherapy drugs after surgery may kill any tumor cells that remain after surgery.

PURPOSE: This phase II trial is studying how well giving docetaxel together with cisplatin works in treating patients with stage I, stage II, or stage III non-small cell lung cancer that has been completely removed by surgery.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Masking open label
Primary purpose treatment

Primary Outcomes

Total cisplatin dose
time frame:

Secondary Outcomes

time frame:
Overall survival
time frame:
Disease-free survival
time frame:

Eligibility Criteria

Male or female participants at least 18 years old.

DISEASE CHARACTERISTICS: - Pathologically proven non-small cell lung cancer (NSCLC) - Stage IA-IIIB disease - Underwent prior complete surgical resection (R0) no more than 2 months ago - Eligible for cisplatin-based adjuvant chemotherapy PATIENT CHARACTERISTICS: - Karnofsky performance status ≥ 70% - Absolute neutrophil count ≥ 1,500/mm^3 - Hemoglobin ≥ 8.0 g/dL - Platelet count ≥ 100,000/mm^3 - Creatinine clearance > 55 mL/min - Total bilirubin normal - Alkaline phosphatase, AST, and ALT must meet 1 of the following criteria: - Alkaline phosphatase (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 - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception during and for 3 months after completion of study treatment - No history of severe hypersensitivity reaction to docetaxel or other drugs formulated with polysorbate 80 - No peripheral neuropathy > grade 1 - No hearing deficit at baseline, even if it does not require a hearing aid or intervention or interfere with activities of daily life (i.e., CTCAE grade 2 or higher) PRIOR CONCURRENT THERAPY: - See Disease Characteristics - No prior postoperative radiation therapy - No prior chemotherapy for NSCLC - No prior docetaxel or cisplatin - No concurrent prophylactic filgrastim (G-CSF) or pegfilgrastim

Additional Information

Official title Phase II Trial of Weekly Docetaxel (Taxotere®) and Monthly Cisplatin Chemotherapy as Adjuvant Treatment for Patients With Completely Resected Non-Small Cell Lung Cancer
Principal investigator Charles M. Rudin, MD, PhD
Description OBJECTIVES: Primary - Compare the efficacy and safety of a new dosing schedule and dosing level of docetaxel and cisplatin with the chemotherapy regimens used in the International Adjuvant Lung Cancer Trial (IALT) in patients with completely resected stage IA-IIIB non-small cell lung cancer. Secondary - Explore the relationship of time to recurrence, disease-free survival, and overall survival of these patients with levels of circulating DNA and proteomic analysis of serum. OUTLINE: This is an open-label study. Patients receive docetaxel IV over 30 minutes on days 1, 8, and 15 and cisplatin IV over 8 hours on day 15. Treatment repeats every 28 days for up to 4 courses in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed periodically. PROJECTED ACCRUAL: A total of 50 patients will be accrued for this study.
Trial information was received from ClinicalTrials.gov and was last updated in February 2009.
Information provided to ClinicalTrials.gov by National Cancer Institute (NCI).