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Status:

TERMINATED

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

Lead Sponsor:

University of Medicine and Dentistry of New Jersey

Collaborating Sponsors:

National Cancer Institute (NCI)

Aventis Pharmaceuticals

Conditions:

Lung Cancer

Eligibility:

All Genders

18-120 years

Phase:

PHASE2

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 ...

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...

Eligibility Criteria

Inclusion

  • 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

Exclusion

    Key Trial Info

    Start Date :

    December 1 2003

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ACTUAL

    End Date :

    February 1 2010

    Estimated Enrollment :

    49 Patients enrolled

    Trial Details

    Trial ID

    NCT00118131

    Start Date

    December 1 2003

    End Date

    February 1 2010

    Last Update

    August 15 2023

    Active Locations (13)

    Enter a location and click search to find clinical trials sorted by distance.

    Page 1 of 4 (13 locations)

    1

    Central Jersey Oncology Center, PA - East Brunswick

    East Brunswick, New Jersey, United States, 08816

    2

    JFK Medical Center in Edison

    Edison, New Jersey, United States, 08818

    3

    CentraState Medical Center

    Freehold, New Jersey, United States, 07728

    4

    Cancer Institute of New Jersey at Hamilton

    Hamilton, New Jersey, United States, 08690