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

• ClinicalTrials.gov Identifier: NCT00118131
• Recruitment Status: Terminated
• First Posted: July 11, 2005
• Results First Posted: November 25, 2013
• Last Update Posted: November 25, 2013
• 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 )

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Lung Cancer	Drug: cisplatin; Drug: docetaxel	Phase 2

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 49 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• 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
• Study Start Date: December 2003
• Actual Primary Completion Date: February 2010
• Actual Study Completion Date: February 2010

Arms and Interventions

Arm	Intervention/treatment
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.	Drug: cisplatin; Drug: docetaxel

Outcome Measures

Primary Outcome Measures :

1. Overall Tumor Response Rate [ Time Frame: 7 years ]
   Patients experiencing complete or partial response

Secondary Outcome Measures :

1. Time to Progressive Disease [ Time Frame: 8 years ]
2. 1-year Survival Rate [ Time Frame: 8 years ]
3. Median Survival Time [ Time Frame: 10 years ]

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

United States, New Jersey

Central Jersey Oncology Center, PA - East Brunswick

East Brunswick, New Jersey, United States, 08816

JFK Medical Center in Edison

Edison, New Jersey, United States, 08818

CentraState Medical Center

Freehold, New Jersey, United States, 07728

Cancer Institute of New Jersey at Hamilton

Hamilton, New Jersey, United States, 08690

Monmouth Medical Center

Long Branch, New Jersey, United States, 07740

Mountainside Hospital Cancer Center

Montclair, New Jersey, United States, 07042

Jersey Shore University Medical Center

Neptune, New Jersey, United States, 07754

Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School

New Brunswick, New Jersey, United States, 08903

Saint Peter's University Hospital

New Brunswick, New Jersey, United States, 08903

UMDNJ - University Hospital

Newark, New Jersey, United States, 07103

Raritan Bay Medical Center

Perth Amboy, New Jersey, United States, 08861

Somerset Medical Center

Somerville, New Jersey, United States, 08876

Overlook Hospital

Summit, New Jersey, United States, 07901

Sponsors and Collaborators

University of Medicine and Dentistry of New Jersey

National Cancer Institute (NCI)

Aventis Pharmaceuticals

Investigators

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

More Information

• Responsible Party: University of Medicine and Dentistry of New Jersey
• ClinicalTrials.gov Identifier: 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 )
• First Posted: July 11, 2005
• Results First Posted: November 25, 2013
• Last Update Posted: November 25, 2013
• Last Verified: September 2013

Keywords provided by Rutgers, The State University of New Jersey ( University of Medicine and Dentistry of New Jersey ):

stage IIIB non-small cell lung cancer; stage IV non-small cell lung cancer; recurrent non-small cell lung cancer

Additional relevant MeSH terms:

Lung Neoplasms; Carcinoma, Non-Small-Cell Lung; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Carcinoma, Bronchogenic; Bronchial Neoplasms; Cisplatin; Docetaxel; Antineoplastic Agents; Tubulin Modulators; Antimitotic Agents; Mitosis Modulators; Molecular Mechanisms of Pharmacological Action