Docetaxel and Cisplatin in Treating Patients With Stage III or Stage IV Non-Small Cell Lung Cancer

Tracking Information
First Submitted Date ICMJE	July 8, 2005
First Posted Date ICMJE	July 11, 2005
Results First Submitted Date	September 19, 2013
Results First Posted Date	November 25, 2013
Last Update Posted Date	November 25, 2013
Study Start Date ICMJE	December 2003
Actual Primary Completion Date	February 2010 (Final data collection date for primary outcome measure)
Current Primary Outcome Measures ICMJE; (submitted: September 19, 2013)	Overall Tumor Response Rate [ Time Frame: 7 years ]; Patients experiencing complete or partial response
Original Primary Outcome Measures ICMJE	Not Provided
Change History	Complete list of historical versions of study NCT00118131 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ICMJE; (submitted: September 19, 2013)	Time to Progressive Disease [ Time Frame: 8 years ]; 1-year Survival Rate [ Time Frame: 8 years ]; Median Survival Time [ Time Frame: 10 years ]
Original Secondary Outcome Measures ICMJE	Not Provided
Current Other Outcome Measures ICMJE	Not Provided
Original Other Outcome Measures ICMJE	Not Provided
Descriptive Information
Brief Title ICMJE	Docetaxel and Cisplatin in Treating Patients With Stage III or Stage IV Non-Small Cell Lung Cancer
Official Title ICMJE	Phase II Study of Weekly Docetaxel Together With Weekly Cisplatin in Chemotherapy-Naive Patients With Stage IV or Select Stage IIIB (Malignant Effusion) Non-Small Cell Lung Cancer
Brief Summary	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 more than one drug (combination chemotherapy) may kill more tumor cells. PURPOSE: This phase II trial is studying how well giving docetaxel together with cisplatin works in treating patients with stage III or stage IV non-small cell lung cancer.
Detailed Description	OBJECTIVES: Primary; Determine the antitumor activity of docetaxel and cisplatin, as measured by tumor response rate, in patients with chemotherapy-naïve stage IIIB or IV non-small cell lung cancer. Secondary; Determine the duration of response in patients treated with this regimen.; Determine time to disease progression in patients treated with this regimen.; Determine the 1-year survival rate in patients treated with this regimen.; Determine the median survival time in patients treated with this regimen.; Correlate aneuploidy (as determined by DNA histograms) and immunohistochemical expression of stathmin, Aurora-A, and survivin with response in patients treated with this regimen. OUTLINE: This is an open-label, nonrandomized, multicenter study. Patients receive docetaxel IV over 1 hour and cisplatin IV over 1 hour once on days 1, 8, and 15. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed every 6 months. PROJECTED ACCRUAL: A total of 76 patients will be accrued for this study within 13-19 months.
Study Type ICMJE	Interventional
Study Phase	Phase 2
Study Design ICMJE	Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment
Condition ICMJE	Lung Cancer
Intervention ICMJE	Drug: cisplatin; Drug: docetaxel
Study Arms	Experimental: Docetaxel and Cisplatin; A cycle is defined as an interval of 28 days. Docetaxel, 35 mg/m2 per day on Days 1, 8 and 15 (total dose for this cycle = 105 mg/m2). Cisplatin, 25 mg/m2 per day on Days 1, 8 and 15 (total dose for this cycle = 75 mg/m2). Docetaxel is always to be given prior to cisplatin on Days 1, 8 and 15.; Interventions: Drug: cisplatin; Drug: docetaxel
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status ICMJE	Terminated
Actual Enrollment ICMJE; (submitted: September 22, 2010)	49
Original Enrollment ICMJE	Not Provided
Actual Study Completion Date	February 2010
Actual Primary Completion Date	February 2010 (Final data collection date for primary outcome measure)
Eligibility Criteria ICMJE	DISEASE CHARACTERISTICS: Histologically or cytologically confirmed non-small cell lung cancer, meeting 1 of the following stage criteria: Stage IIIB disease with malignant pericardial or malignant pleural effusions, as indicated by 1 of the following: Positive cytology Exudative effusion AND lactic dehydrogenase (LDH) > 200 IU with effusion/serum LDH ratio ≥ 0.6 Stage IV disease; Measurable disease, defined as ≥ 1 unidimensionally measurable lesion > 20 mm by conventional techniques OR > 10 mm by spiral CT scan; Brain metastases allowed provided they have been irradiated AND are radiographically stable for ≥ 28 days after the completion of radiotherapy PATIENT CHARACTERISTICS: Age; 18 and over Performance status; ECOG 0-1 Life expectancy; At least 12 weeks Hematopoietic; Absolute neutrophil count ≥ 1,500/mm^3; Platelet count ≥ 100,000/mm^3; Hemoglobin ≥ 8.0 g/dL Hepatic; AST and ALT normal; Bilirubin normal Renal; Creatinine clearance ≥ 50 mL/min Immunologic; No known HIV positivity; No history of severe hypersensitivity reaction to docetaxel or other drugs formulated with polysorbate 80; No clinically significant active infection Other; Not pregnant or nursing; Fertile patients must use effective contraception before, during, and for 4 weeks after completion of study treatment; No other primary malignancy within the past 5 years except adequately treated nonmelanoma skin cancer or carcinoma in situ of the cervix; No other serious systemic disorder that would preclude study participation; No other condition that would preclude study compliance PRIOR CONCURRENT THERAPY: Biologic therapy; Prior antibody-based therapy that targets growth factor pathways (e.g., epidermal growth factor receptor [EGFR]) allowed provided there is disease progression during therapy and patient has recovered; No concurrent immunotherapy; No concurrent prophylactic colony-stimulating factors; No concurrent interleukin-11 Chemotherapy; No prior cytotoxic chemotherapy; No other concurrent chemotherapy Endocrine therapy; No concurrent hormonal therapy for the malignancy Radiotherapy; See Disease Characteristics; More than 28 days since prior radiotherapy and recovered; No prior radiotherapy to ≥ 25% of the bone marrow; No prior radiotherapy to sites of measurable disease unless there is documented tumor progression after completion of radiotherapy; No concurrent radiotherapy Surgery; No concurrent surgery for the malignancy Other; More than 3 weeks since prior investigational drugs; Prior oral small molecule drug therapy that targets growth factor pathways (e.g., EGFR) allowed provided there is disease progression during therapy and patient has recovered; No other concurrent investigational or commercial agents or therapies for the malignancy
Sex/Gender	Sexes Eligible for Study: All
Ages	18 Years and older (Adult, Senior)
Accepts Healthy Volunteers	No
Contacts ICMJE	Contact information is only displayed when the study is recruiting subjects
Listed Location Countries ICMJE	United States
Removed Location Countries
Administrative Information
NCT Number ICMJE	NCT00118131
Other Study ID Numbers ICMJE	CDR0000433488; P30CA072720 ( U.S. NIH Grant/Contract ); CINJ-030302 ( Other Identifier: Cancer Institute of New Jersey ); CINJ-NJ1503 ( Other Identifier: Cancer Institute of New Jersey )
Has Data Monitoring Committee	No
U.S. FDA-regulated Product	Not Provided
IPD Sharing Statement	Not Provided
Responsible Party	Rutgers, The State University of New Jersey ( University of Medicine and Dentistry of New Jersey )
Study Sponsor ICMJE	University of Medicine and Dentistry of New Jersey
Collaborators ICMJE	National Cancer Institute (NCI); Aventis Pharmaceuticals
Investigators ICMJE	Principal Investigator: Joseph Aisner, MD Rutgers Cancer Institute of New Jersey
PRS Account	Rutgers, The State University of New Jersey
Verification Date	September 2013
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP