Two Regimens of Docetaxel in Treating Patients Who Have Not Received Chemotherapy For Unresectable Stage IIIB or Stage IV Non-Small Cell Lung Cancer
Recruitment status was Active, not recruiting
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Lung Cancer |
Drug: docetaxel |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Masking: Open Label Primary Purpose: Treatment |
| 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 Start Date: | October 2003 |
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations| United States, Ohio | |
| Ireland Cancer Center | |
| Cleveland, Ohio, United States, 44106-5065 | |
| Principal Investigator: | Afshin Dowlati, MD | Case Comprehensive Cancer Center |
More Information
Additional Information:
No publications provided
| ClinicalTrials.gov Identifier: | NCT00075374 History of Changes |
| Other Study ID Numbers: | CDR0000346070, CWRU-MSMC-1503, AVENTIS-GIA-12143, THERADEX-GIA-12143, MTSMC-LUN06 |
| Study First Received: | January 9, 2004 |
| Last Updated: | February 10, 2011 |
| Health Authority: | United States: Federal Government |
Keywords provided by National Cancer Institute (NCI):
|
stage IIIB non-small cell lung cancer stage IV non-small cell lung cancer recurrent non-small cell lung cancer |
Additional relevant MeSH terms:
|
Carcinoma, Non-Small-Cell Lung Lung Neoplasms Carcinoma, Bronchogenic Bronchial Neoplasms Respiratory Tract Neoplasms Thoracic Neoplasms Neoplasms by Site |
Neoplasms Lung Diseases Respiratory Tract Diseases Docetaxel Antineoplastic Agents Therapeutic Uses Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 22, 2013