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

Lung Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00118131
• Other study ID #: CDR0000433488
• Secondary ID: P30CA072720CINJ-
• Status: Terminated
• Phase: Phase 2
• Start date: December 2003
• Est. completion date: February 2010

Study information

• Verified date: July 2023
• Source: Rutgers, The State University of New Jersey
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 49
• Est. completion date: February 2010
• Est. primary completion date: February 2010
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 120 Years

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Cancer
• Lung Neoplasms

Intervention

Drug:
• cisplatin

• docetaxel

Locations

Country	Name	City	State
United States	Central Jersey Oncology Center, PA - East Brunswick	East Brunswick	New Jersey
United States	JFK Medical Center in Edison	Edison	New Jersey
United States	CentraState Medical Center	Freehold	New Jersey
United States	Cancer Institute of New Jersey at Hamilton	Hamilton	New Jersey
United States	Monmouth Medical Center	Long Branch	New Jersey
United States	Mountainside Hospital Cancer Center	Montclair	New Jersey
United States	Jersey Shore University Medical Center	Neptune	New Jersey
United States	Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School	New Brunswick	New Jersey
United States	Saint Peter's University Hospital	New Brunswick	New Jersey
United States	UMDNJ - University Hospital	Newark	New Jersey
United States	Raritan Bay Medical Center	Perth Amboy	New Jersey
United States	Somerset Medical Center	Somerville	New Jersey
United States	Overlook Hospital	Summit	New Jersey

Sponsors (3)

Lead Sponsor	Collaborator
University of Medicine and Dentistry of New Jersey	Aventis Pharmaceuticals, National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall Tumor Response Rate	Patients experiencing complete or partial response. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.", or similar definition that is accurate and appropriate.	7 years
Secondary	Time to Progressive Disease	Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.	8 years
Secondary	1-year Survival Rate		1 year
Secondary	Median Survival Time		10 years