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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


Phase 2
18 Years
N/A
Not Enrolling
Both
Lung Cancer

Thank you

Trial Information

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


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.

Inclusion 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

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Overall tumor response rate

Safety Issue:

No

Principal Investigator

Joseph Aisner, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Cancer Institute of New Jersey

Authority:

United States: Federal Government

Study ID:

CDR0000433488

NCT ID:

NCT00118131

Start Date:

December 2003

Completion Date:

February 2010

Related Keywords:

  • Lung Cancer
  • stage IIIB non-small cell lung cancer
  • stage IV non-small cell lung cancer
  • recurrent non-small cell lung cancer
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms

Name

Location

Overlook Hospital Summit, New Jersey  07902-0220
Cancer Institute of New Jersey at Hamilton Hamilton, New Jersey  08690
Saint Peter's University Hospital New Brunswick, New Jersey  08901-1780
Somerset Medical Center Somerville, New Jersey  08876
Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School New Brunswick, New Jersey  08903
Raritan Bay Medical Center Perth Amboy, New Jersey  08861
Mountainside Hospital Cancer Center Montclair, New Jersey  07042
CentraState Medical Center Freehold, New Jersey  07728
Central Jersey Oncology Center, PA - East Brunswick East Brunswick, New Jersey  08816