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

This study has been terminated.
(Slow accrual)
Sponsor:
Collaborators:
Aventis Pharmaceuticals
Information provided by (Responsible Party):
Rutgers, The State University of New Jersey ( University of Medicine and Dentistry of New Jersey )
ClinicalTrials.gov Identifier:
NCT00118131
First received: July 8, 2005
Last updated: September 19, 2013
Last verified: September 2013
  Purpose

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 Intervention Phase
Lung Cancer
Drug: cisplatin
Drug: docetaxel
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Rutgers, The State University of New Jersey:

Primary Outcome Measures:
  • Overall Tumor Response Rate [ Time Frame: 7 years ] [ Designated as safety issue: No ]
    Patients experiencing complete or partial response


Secondary Outcome Measures:
  • Time to Progressive Disease [ Time Frame: 8 years ] [ Designated as safety issue: No ]
  • 1-year Survival Rate [ Time Frame: 8 years ] [ Designated as safety issue: No ]
  • Median Survival Time [ Time Frame: 10 years ] [ Designated as safety issue: No ]

Enrollment: 49
Study Start Date: December 2003
Study Completion Date: February 2010
Primary Completion Date: February 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00118131

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
Aventis Pharmaceuticals
Investigators
Principal Investigator: Joseph Aisner, MD Rutgers Cancer Institute of New Jersey
  More Information

No publications provided

Responsible Party: Rutgers, The State University of New Jersey ( University of Medicine and Dentistry of New Jersey )
ClinicalTrials.gov Identifier: NCT00118131     History of Changes
Other Study ID Numbers: CDR0000433488, P30CA072720, CINJ-030302, CINJ-NJ1503
Study First Received: July 8, 2005
Results First Received: September 19, 2013
Last Updated: September 19, 2013
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board

Keywords provided by Rutgers, The State University 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:
Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Carcinoma, Bronchogenic
Bronchial Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Docetaxel
Cisplatin
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Radiation-Sensitizing Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on September 22, 2014