Two Regimens of Docetaxel in Treating Patients Who Have Not Received Chemotherapy For Unresectable Stage IIIB or Stage IV Non-Small Cell Lung Cancer

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Primary Purpose

Status

Completed

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

docetaxel

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 Unresectable stage IIIB or IV disease No untreated brain or leptomeningeal metastases Treated patients must be neurologically stable and the adverse effects from prior therapy must be resolved to grade 2 or less after the completion of treatment No symptomatic (i.e., requiring thoracentesis) pleural effusion No clinically significant (i.e., grade 3 or greater) pericardial effusion PATIENT CHARACTERISTICS: Age 18 and over Performance status ECOG 0-2 (70 years of age and over) OR ECOG 2 (under 70 years of age) Life expectancy Not specified Hematopoietic Absolute neutrophil count at least 1,500/mm^3 Platelet count at least 100,000/mm^3 Hemoglobin at least 8.0 g/dL Hepatic Bilirubin normal AST and ALT no greater than 2.5 times upper limit of normal (ULN) if alkaline phosphatase is no greater than ULN OR Alkaline phosphatase no greater than 4 times ULN if ALT and AST are no greater than ULN Renal Not specified Other Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception during and for 6 months after study participation No grade 2 or greater peripheral neuropathy No prior hypersensitivity reaction to taxanes or products containing polysorbate 80 No other active malignancy except carcinoma in situ of the cervix or basal cell skin cancer No psychological, familial, sociological, or geographical condition that would preclude study treatment or follow-up PRIOR CONCURRENT THERAPY: Biologic therapy Not specified Chemotherapy No prior chemotherapy Endocrine therapy Not specified Radiotherapy Recovered from prior radiotherapy (i.e., side effects resolved to grade 2 or less) No concurrent radiotherapy Surgery More than 3 weeks since prior major surgery Other More than 30 days since prior anticancer investigational drugs Concurrent supportive care investigational agents allowed

Sites / Locations

Ireland Cancer Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Docetaxel

Arm Description

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

NCT ID

NCT00075374

First Posted

January 9, 2004

Last Updated

January 15, 2014

Sponsor

Case Comprehensive Cancer Center

Collaborators

National Cancer Institute (NCI)

1. Study Identification

Unique Protocol Identification Number

NCT00075374

Brief Title

Two Regimens of Docetaxel in Treating Patients Who Have Not Received Chemotherapy For Unresectable Stage IIIB or Stage IV Non-Small Cell Lung Cancer

Official Title

A Multicenter, Randomized Phase II Study of Two Schedules of Taxotere (Weekly Versus Every 3 Weeks) in Elderly or Poor Performance (ECOG PS 2), Chemotherapy-Naive Patients With Advanced Non-Small Cell Lung Cancer

Study Type

Interventional

2. Study Status

Record Verification Date

January 2014

Overall Recruitment Status

Completed

Study Start Date

October 2003 (undefined)

Primary Completion Date

April 2005 (Actual)

Study Completion Date

April 2005 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

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 docetaxel, use different ways to stop tumor cells from dividing so they stop growing or die. It is not yet known which docetaxel regimen is more effective for non-small cell lung cancer. PURPOSE: Randomized phase II trial to compare the effectiveness of two regimens of docetaxel in treating patients who have not previously received chemotherapy for unresectable stage IIIB or stage IV non-small cell lung cancer.

Detailed Description

OBJECTIVES: Primary Compare the effects of two different schedules of docetaxel on the incidence of grade 3 and 4 toxic effects in older or poor performance chemotherapy-naïve patients with unresectable stage IIIB or IV non-small cell lung cancer. Secondary Compare the overall survival of patients treated with these regimens. Compare the response rate in patients treated with these regimens. Compare the incidence of serious adverse events in patients treated with these regimens. Determine the quality of life of patients treated with these regimens. OUTLINE: This is an open-label, randomized, multicenter study. Patients are randomized to 1 of 2 treatment arms. Arm I: Patients receive docetaxel IV over 1 hour on day 1. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity. Arm II: Patients receive docetaxel IV over 30 minutes on days 1, 8, and 15. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity. Quality of life is assessed at baseline, every 2 courses during study treatment, and then at study completion. Patients are followed at 1 month and then every 2-3 months thereafter. PROJECTED ACCRUAL: A total of 210-230 patients (105-115 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 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

6 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Docetaxel

Arm Type

Experimental

Intervention Type

Drug

Intervention Name(s)

docetaxel

Other Intervention Name(s)

Taxotere, Docefrez

Intervention Description

Patients receive docetaxel IV over 1 hour on day 1. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity. OR Patients receive docetaxel IV over 30 minutes on days 1, 8, and 15. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity. Quality of life is assessed at baseline, every 2 courses during study treatment, and then at study completion. Patients are followed at 1 month and then every 2-3 months thereafter.

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 Unresectable stage IIIB or IV disease No untreated brain or leptomeningeal metastases Treated patients must be neurologically stable and the adverse effects from prior therapy must be resolved to grade 2 or less after the completion of treatment No symptomatic (i.e., requiring thoracentesis) pleural effusion No clinically significant (i.e., grade 3 or greater) pericardial effusion PATIENT CHARACTERISTICS: Age 18 and over Performance status ECOG 0-2 (70 years of age and over) OR ECOG 2 (under 70 years of age) Life expectancy Not specified Hematopoietic Absolute neutrophil count at least 1,500/mm^3 Platelet count at least 100,000/mm^3 Hemoglobin at least 8.0 g/dL Hepatic Bilirubin normal AST and ALT no greater than 2.5 times upper limit of normal (ULN) if alkaline phosphatase is no greater than ULN OR Alkaline phosphatase no greater than 4 times ULN if ALT and AST are no greater than ULN Renal Not specified Other Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception during and for 6 months after study participation No grade 2 or greater peripheral neuropathy No prior hypersensitivity reaction to taxanes or products containing polysorbate 80 No other active malignancy except carcinoma in situ of the cervix or basal cell skin cancer No psychological, familial, sociological, or geographical condition that would preclude study treatment or follow-up PRIOR CONCURRENT THERAPY: Biologic therapy Not specified Chemotherapy No prior chemotherapy Endocrine therapy Not specified Radiotherapy Recovered from prior radiotherapy (i.e., side effects resolved to grade 2 or less) No concurrent radiotherapy Surgery More than 3 weeks since prior major surgery Other More than 30 days since prior anticancer investigational drugs Concurrent supportive care investigational agents allowed

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Afshin Dowlati, MD

Organizational Affiliation

Case Comprehensive Cancer Center

Official's Role

Principal Investigator

Facility Information:

Facility Name

Ireland Cancer Center

City

Cleveland

State/Province

Ohio

ZIP/Postal Code

44106-5065

Country

United States

Lung Cancer

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

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