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

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

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.

Study Overview

• Status: Terminated
• Conditions: Lung Cancer
• Intervention / Treatment: Drug: docetaxel; Drug: cisplatin

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.

• Study Type: Interventional
• Enrollment (Actual): 49
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • New Jersey
    • East Brunswick, New Jersey, United States, 08816
      • Central Jersey Oncology Center, PA - East Brunswick
    • Edison, New Jersey, United States, 08818
      • JFK Medical Center in Edison
    • Freehold, New Jersey, United States, 07728
      • CentraState Medical Center
    • Hamilton, New Jersey, United States, 08690
      • Cancer Institute of New Jersey at Hamilton
    • Long Branch, New Jersey, United States, 07740
      • Monmouth Medical Center
    • Montclair, New Jersey, United States, 07042
      • Mountainside Hospital Cancer Center
    • Neptune, New Jersey, United States, 07754
      • Jersey Shore University Medical Center
    • New Brunswick, New Jersey, United States, 08903
      • Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School
    • New Brunswick, New Jersey, United States, 08903
      • Saint Peter's University Hospital
    • Newark, New Jersey, United States, 07103
      • UMDNJ - University Hospital
    • Perth Amboy, New Jersey, United States, 08861
      • Raritan Bay Medical Center
    • Somerville, New Jersey, United States, 08876
      • Somerset Medical Center
    • Summit, New Jersey, United States, 07901
      • Overlook Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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: docetaxel; Drug: cisplatin

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall Tumor Response Rate	Patients experiencing complete or partial response. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.", or similar definition that is accurate and appropriate.	7 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Median Survival Time		10 years
Time to Progressive Disease	Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.	8 years
1-year Survival Rate		1 year

Collaborators and Investigators

• Sponsor: University of Medicine and Dentistry of New Jersey
• Collaborators: National Cancer Institute (NCI); Aventis Pharmaceuticals
• Investigators: Principal Investigator: Joseph Aisner, MD, Rutgers Cancer Institute of New Jersey

Study record dates

Study Major Dates

• Study Start: December 1, 2003
• Primary Completion (Actual): February 1, 2010
• Study Completion (Actual): February 1, 2010

Study Registration Dates

• First Submitted: July 8, 2005
• First Submitted That Met QC Criteria: July 8, 2005
• First Posted (Estimated): July 11, 2005

Study Record Updates

• Last Update Posted (Actual): August 15, 2023
• Last Update Submitted That Met QC Criteria: July 31, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Keywords: recurrent non-small cell lung cancer; stage IIIB non-small cell lung cancer; stage IV non-small cell lung cancer
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Carcinoma, Non-Small-Cell Lung; Molecular Mechanisms of Pharmacological Action; Antineoplastic Agents; Tubulin Modulators; Antimitotic Agents; Mitosis Modulators; Docetaxel; Cisplatin
• Other Study ID Numbers: CDR0000433488; P30CA072720 (U.S. NIH Grant/Contract); CINJ-030302 (Other Identifier: Cancer Institute of New Jersey); CINJ-NJ1503 (Other Identifier: Cancer Institute of New Jersey)