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

NCT ID: NCT00118131

Last Updated: 2023-08-15

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 49 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2003-12-31
• Study Completion Date: 2010-02-28

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.

Conditions

Lung Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

cisplatin

Intervention Type: DRUG

docetaxel

Intervention Type: DRUG

Interventions

cisplatin

Intervention Type: DRUG

docetaxel

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 120 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

Aventis Pharmaceuticals

INDUSTRY

Sponsor Role: collaborator

University of Medicine and Dentistry of New Jersey

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Joseph Aisner, MD

Role: PRINCIPAL_INVESTIGATOR

Rutgers Cancer Institute of New Jersey

Locations

Central Jersey Oncology Center, PA - East Brunswick

East Brunswick, New Jersey, United States

JFK Medical Center in Edison

Edison, New Jersey, United States

CentraState Medical Center

Freehold, New Jersey, United States

Cancer Institute of New Jersey at Hamilton

Hamilton, New Jersey, United States

Monmouth Medical Center

Long Branch, New Jersey, United States

Mountainside Hospital Cancer Center

Montclair, New Jersey, United States

Jersey Shore University Medical Center

Neptune City, New Jersey, United States

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

New Brunswick, New Jersey, United States

Saint Peter's University Hospital

New Brunswick, New Jersey, United States

UMDNJ - University Hospital

Newark, New Jersey, United States

Raritan Bay Medical Center

Perth Amboy, New Jersey, United States

Somerset Medical Center

Somerville, New Jersey, United States

Overlook Hospital

Summit, New Jersey, United States

Countries

United States

Other Identifiers

P30CA072720

Identifier Type: NIH

Identifier Source: secondary_id

View Link

CINJ-030302

Identifier Type: OTHER

Identifier Source: secondary_id

CINJ-NJ1503

Identifier Type: OTHER

Identifier Source: secondary_id

CDR0000433488

Identifier Type: -

Identifier Source: org_study_id