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Gemcitabine and Carboplatin Followed By Docetaxel in Treating Patients With Stage IIIB or Stage IV Non-Small Cell Lung Cancer

Primary Purpose

Lung Cancer

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
carboplatin
docetaxel
gemcitabine hydrochloride
Sponsored by
Case Comprehensive Cancer Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lung Cancer focused on measuring stage IIIB non-small cell lung cancer, stage IV non-small cell lung cancer, recurrent non-small cell lung cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Immediate Docetaxel

Delayed Docetaxel

Arm Description

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.

Outcomes

Primary Outcome Measures

Survival

Secondary Outcome Measures

Response rate (partial and complete response)
Time to progression
Toxicity as measured by NCI CTC
Quality of life as measured by the lung cancer symptom scale

Full Information

First Posted
December 10, 2003
Last Updated
August 13, 2010
Sponsor
Case Comprehensive Cancer Center
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00074204
Brief Title
Gemcitabine and Carboplatin Followed By Docetaxel in Treating Patients With Stage IIIB or Stage IV Non-Small Cell Lung Cancer
Official Title
A Phase III Study of Delayed vs. Immediate Second-Line Therapy With Docetaxel After Gemcitabine + Carboplatin in Advanced Non-Small Cell Lung Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
August 2010
Overall Recruitment Status
Completed
Study Start Date
October 2003 (undefined)
Primary Completion Date
August 2005 (Actual)
Study Completion Date
April 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Case Comprehensive Cancer Center
Collaborators
National Cancer Institute (NCI)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lung Cancer
Keywords
stage IIIB non-small cell lung cancer, stage IV non-small cell lung cancer, recurrent non-small cell lung cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
17 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Immediate Docetaxel
Arm Type
Experimental
Arm Description
Arm I (immediate docetaxel): Patients receive immediate docetaxel IV over 1 hour on day 1.
Arm Title
Delayed Docetaxel
Arm Type
Active Comparator
Arm Description
Arm II (delayed docetaxel): Patients are observed until first evidence of disease progression and then receive docetaxel IV over 1 hour on day 1.
Intervention Type
Drug
Intervention Name(s)
carboplatin
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
docetaxel
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
gemcitabine hydrochloride
Intervention Description
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.
Primary Outcome Measure Information:
Title
Survival
Time Frame
Patients are followed monthly for 3 months, every 2 months for 6 months, and then every 3 months thereafter
Secondary Outcome Measure Information:
Title
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
Title
Time to progression
Time Frame
treatment repeats every 3 weeks for up to 6 courses in the absence of disease progression.
Title
Toxicity as measured by NCI CTC
Time Frame
at baseline and at the end of each course not at day 8
Title
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.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nathan Levitan, MD
Organizational Affiliation
Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106-5065
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Gemcitabine and Carboplatin Followed By Docetaxel in Treating Patients With Stage IIIB or Stage IV Non-Small Cell Lung Cancer

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