Clinical trial NCT00118131: 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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Lung Cancer
Keywords: stage IIIB non-small cell lung cancer
stage IV non-small cell lung cancer
recurrent non-small cell lung cancer
Lead sponsor: Rutgers, The State University of New Jersey
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
name: Aventis Pharmaceuticals
First posted: 2005-07-11
Enrollment: 49
Sex: ALL
Minimum age (years): 18
Maximum age (years): 120
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Overall Tumor Response Rate
timeFrame: 7 years
Secondary outcomes:
measure: Time to Progressive Disease
timeFrame: 8 years
measure: 1-year Survival Rate
timeFrame: 1 year
measure: Median Survival Time
timeFrame: 10 years
Other outcomes:
Locations:
city: East Brunswick
country: United States
facility: Central Jersey Oncology Center, PA - East Brunswick
state: New Jersey
city: Edison
country: United States
facility: JFK Medical Center in Edison
state: New Jersey
city: Freehold
country: United States
facility: CentraState Medical Center
state: New Jersey
city: Hamilton
country: United States
facility: Cancer Institute of New Jersey at Hamilton
state: New Jersey
city: Long Branch
country: United States
facility: Monmouth Medical Center
state: New Jersey
city: Montclair
country: United States
facility: Mountainside Hospital Cancer Center
state: New Jersey
city: Neptune
country: United States
facility: Jersey Shore University Medical Center
state: New Jersey
city: New Brunswick
country: United States
facility: Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School
state: New Jersey
city: New Brunswick
country: United States
facility: Saint Peter's University Hospital
state: New Jersey
city: Newark
country: United States
facility: UMDNJ - University Hospital
state: New Jersey
city: Perth Amboy
country: United States
facility: Raritan Bay Medical Center
state: New Jersey
city: Somerville
country: United States
facility: Somerset Medical Center
state: New Jersey
city: Summit
country: United States
facility: Overlook Hospital
state: New Jersey
Study officials:
affiliation: Rutgers Cancer Institute of New Jersey
name: Joseph Aisner, MD
role: PRINCIPAL_INVESTIGATOR
References: