- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00074204
Gemcitabine and Carboplatin Followed By Docetaxel in Treating Patients With Stage IIIB or Stage IV Non-Small Cell Lung Cancer
A Phase III Study of Delayed vs. Immediate Second-Line Therapy With Docetaxel After Gemcitabine + Carboplatin in Advanced Non-Small Cell Lung Cancer
RATIONALE: Drugs used in chemotherapy, such as gemcitabine, carboplatin, and docetaxel, use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. It is not yet known which treatment regimen is more effective for stage IIIB or stage IV non-small cell lung cancer.
PURPOSE: Randomized phase III trial to compare the effectiveness of gemcitabine and carboplatin followed immediately by docetaxel with that of giving delayed docetaxel in treating patients who have stage IIIB or stage IV non-small cell lung cancer.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
OBJECTIVES:
Primary
- Compare the overall survival of patients with stage IIIB or IV non-small cell lung cancer treated with gemcitabine and carboplatin followed by immediate vs delayed docetaxel.
Secondary
- Compare the response rate and time to progression in patients treated with these regimens.
- Compare the toxicity of these regimens in these patients.
- Compare the quality of life of patients treated with these regimens.
OUTLINE: This is a randomized study. Patients are stratified according to ECOG performance status (0 or 1 vs 2).
All patients receive gemcitabine IV over 30-60 minutes on days 1 and 8 and carboplatin IV over 30-60 minutes on day 1. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity.
Patients with stable or responding disease proceed to docetaxel therapy. Patients are randomized to 1 of 2 treatment arms.
- Arm I (immediate docetaxel): Patients receive immediate docetaxel IV over 1 hour on day 1.
- Arm II (delayed docetaxel): Patients are observed until first evidence of disease progression and then receive docetaxel IV over 1 hour on day 1.
In both arms, treatment repeats every 3 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity.
Quality of life (QOL) is assessed at baseline, at restaging (after completion of gemcitabine and carboplatin), before courses 2-6 of docetaxel*, and then at 1 and 3 months after study treatment.
NOTE: *For patients randomized to delayed docetaxel, QOL is assessed every 3 weeks until first disease progression and then before courses 2-6 of docetaxel
Patients are followed monthly for 3 months, every 2 months for 6 months, and then every 3 months thereafter.
PROJECTED ACCRUAL: A total of 550 patients (275 per treatment arm) will be accrued for this study.
Study Type
Enrollment (Actual)
Phase
- Phase 3
Contacts and Locations
Study Locations
-
-
Ohio
-
Cleveland, Ohio, United States, 44106-5065
- Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
DISEASE CHARACTERISTICS:
Histologically or cytologically confirmed non-small cell lung cancer (NSCLC)
- Stage IIIB with pleural effusion OR stage IV disease
- Recurrent disease after primary treatment with radiotherapy or surgery allowed
Measurable disease or nonmeasurable disease
- Measurable disease, defined as at least 1 unidimensionally measurable lesion at least 20 mm by conventional techniques OR at least 10 mm by spiral CT scan
Nonmeasurable disease, defined as all other lesions, including small lesions (longest diameter less than 20 mm by conventional techniques OR less than 10 mm by spiral CT scan) or any of the following:
- Bone lesions
- Leptomeningeal disease
- Ascites
- Pleural/pericardial effusion
- Inflammatory breast disease
- Lymphangitis cutis/pulmonis
- Cystic lesions
- Abdominal masses not confirmed and followed by imaging techniques
No symptomatic CNS metastases
- Treated, stable CNS metastases allowed provided patient is not receiving radiotherapy or corticosteroids
PATIENT CHARACTERISTICS:
Age
- Over 18
Performance status
- ECOG 0-2
Life expectancy
- At least 12 weeks
Hematopoietic
- WBC at least 3,000/mm^3
- Absolute neutrophil count at least 1,000/mm^3
- Platelet count at least 100,000/mm^3
Hepatic
- Bilirubin no greater than 1.5 mg/dL
- SGOT no greater than 3.0 times upper limit of normal (ULN) (less than 5.0 times ULN for patients with documented benign disease)
- Alkaline phosphatase less than 3.0 times ULN (for patients with documented benign disease)
Renal
- Creatinine no greater than 1.5 mg/dL
Other
- Not pregnant or nursing
- Fertile patients must use effective contraception during and for 3 months after study participation
- No active and ongoing infection
- No concurrent serious systemic disorder that would preclude study participation
No other primary malignancy within the past 5 years except carcinoma in situ of the cervix, adequately treated basal cell skin cancer, or T1 vocal cord cancer in remission
- Other prior cancers unlikely to affect survival for the next 3 years (e.g., low-grade early stage prostate cancer) are allowed
PRIOR CONCURRENT THERAPY:
Biologic therapy
- No concurrent immunotherapy
Chemotherapy
- No prior chemotherapy for NSCLC, including neoadjuvant and adjuvant therapy
- No other concurrent chemotherapy
Endocrine therapy
- See Disease Characteristics
- No concurrent antitumor hormonal therapy (excluding contraceptives and replacement steroids)
Radiotherapy
- See Disease Characteristics
- At least 3 weeks since prior radiotherapy and recovered
- Prior radiotherapy to less than 25% of bone marrow allowed provided the irradiated area is not the only site of measurable disease
- No concurrent radiotherapy
Surgery
- See Disease Characteristics
Other
- At least 3 weeks since prior therapy for cancer
- More than 4 weeks since prior investigational agents
- No other concurrent experimental medications
- No other concurrent therapy for cancer
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Immediate Docetaxel
Arm I (immediate docetaxel): Patients receive immediate docetaxel IV over 1 hour on day 1.
|
Carboplatin IV over 30-60 minutes on day 1.
Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity.
Arm I (immediate docetaxel): Patients receive immediate docetaxel IV over 1 hour on day 1. Arm II (delayed docetaxel): Patients are observed until first evidence of disease progression and then receive docetaxel IV over 1 hour on day 1. In both arms, treatment repeats every 3 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity.
Gemcitabine IV over 30-60 minutes on days 1 and 8. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity.
|
Active Comparator: Delayed Docetaxel
Arm II (delayed docetaxel): Patients are observed until first evidence of disease progression and then receive docetaxel IV over 1 hour on day 1.
|
Carboplatin IV over 30-60 minutes on day 1.
Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity.
Arm I (immediate docetaxel): Patients receive immediate docetaxel IV over 1 hour on day 1. Arm II (delayed docetaxel): Patients are observed until first evidence of disease progression and then receive docetaxel IV over 1 hour on day 1. In both arms, treatment repeats every 3 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity.
Gemcitabine IV over 30-60 minutes on days 1 and 8. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Survival
Time Frame: Patients are followed monthly for 3 months, every 2 months for 6 months, and then every 3 months thereafter
|
Patients are followed monthly for 3 months, every 2 months for 6 months, and then every 3 months thereafter
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Response rate (partial and complete response)
Time Frame: Patients are followed monthly for 3 months, every 2 months for 6 months, and then every 3 months thereafter
|
Patients are followed monthly for 3 months, every 2 months for 6 months, and then every 3 months thereafter
|
Time to progression
Time Frame: treatment repeats every 3 weeks for up to 6 courses in the absence of disease progression.
|
treatment repeats every 3 weeks for up to 6 courses in the absence of disease progression.
|
Toxicity as measured by NCI CTC
Time Frame: at baseline and at the end of each course not at day 8
|
at baseline and at the end of each course not at day 8
|
Quality of life as measured by the lung cancer symptom scale
Time Frame: At baseline, at restaging, before courses 2-6 of docetaxel*, and then at 1 and 3 months after study treatment. Arm II, QOL is assessed every 3 weeks until first disease progression and then before courses 2-6 of docetaxel.
|
At baseline, at restaging, before courses 2-6 of docetaxel*, and then at 1 and 3 months after study treatment. Arm II, QOL is assessed every 3 weeks until first disease progression and then before courses 2-6 of docetaxel.
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Nathan Levitan, MD, Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
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
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Anti-Infective Agents
- Antiviral Agents
- Enzyme Inhibitors
- Antimetabolites, Antineoplastic
- Antimetabolites
- Antineoplastic Agents
- Immunosuppressive Agents
- Immunologic Factors
- Tubulin Modulators
- Antimitotic Agents
- Mitosis Modulators
- Gemcitabine
- Docetaxel
- Carboplatin
Other Study ID Numbers
- LILY1503
- P30CA043703 (U.S. NIH Grant/Contract)
- CASE-CWRU-LILY-1503 (Other Identifier: Case Comprehensive Cancer Center)
- LILLY-B9E-US-S245
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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