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

• Sponsor: University of Medicine and Dentistry of New Jersey
• Collaborators: National Cancer Institute (NCI); Aventis Pharmaceuticals
• Information provided by (Responsible Party): Rutgers, The State University of New Jersey ( University of Medicine and Dentistry of New Jersey )

Tracking Information

• First Submitted Date: July 8, 2005
• First Posted Date: 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: December 2003
• Actual Primary Completion Date: February 2010 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: September 19, 2013)

Overall Tumor Response Rate [ Time Frame: 7 years ]

Patients experiencing complete or partial response

• Original Primary Outcome Measures: Not Provided
• Change History: Complete list of historical versions of study NCT00118131 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures (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: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

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

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: Interventional
• Study Phase: Phase 2
• Study Design: Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Lung Cancer

Intervention

• 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

Recruitment Information

• Recruitment Status: Terminated
• Actual Enrollment (submitted: September 22, 2010): 49
• Original Enrollment: Not Provided
• Actual Study Completion Date: February 2010
• Actual Primary Completion Date: February 2010 (Final data collection date for primary outcome measure)

Eligibility Criteria

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, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT00118131
• Other Study ID Numbers: 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: University of Medicine and Dentistry of New Jersey

Collaborators

• National Cancer Institute (NCI)
• Aventis Pharmaceuticals

Investigators

• Principal Investigator: Joseph Aisner, MD; Rutgers Cancer Institute of New Jersey

• PRS Account: Rutgers, The State University of New Jersey
• Verification Date: September 2013