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Mesothelioma Related Clinical Trials:
Phase II Study of Gemcitabine and Epirubicin for the Treatment of Mesothelioma
- General Info - Purpose - Eligibility - Contacts & Locations - Additional Information
Status: Active
Sponsors and Collaborators: North Central Cancer Treatment Group, National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
Government Identifier: NCT00017186
Condition: Malignant Mesothelioma
Intervention: Drug: epirubicin hydrochloride; Drug: gemcitabine hydrochloride; Procedure: chemotherapy
Purpose:
RATIONALE: Drugs used in chemotherapy 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.
PURPOSE: Phase II trial to study the effectiveness of combining gemcitabine and epirubicin in treating patients who have malignant mesothelioma.
| Study Type: | Interventional |
| Study Design: | Treatment, Open Label |
| Official Title: | Phase II Study of Gemcitabine and Epirubicin for the Treatment of Mesothelioma |
| Study Start Date: | July 2001 |
Detailed Description:
OBJECTIVES:
- Determine the antitumor activity of gemcitabine and epirubicin in patients with malignant pleural mesothelioma.
- Determine the toxicity of this regimen in this patient population.
- Determine the time to progression and overall survival of patients treated with this regimen.
- Assess quality of life in patients treated with this regimen.
OUTLINE: This is a multicenter study.
Patients receive gemcitabine IV over 30 minutes on days 1 and 8 and epirubicin IV on day 1. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients achieving complete response (CR) receive 2 additional courses beyond CR.
Quality of life is assessed at baseline, prior to course 3, at 3 months, and then at 1 year.
Patients are followed every 3 months for 1 year, every 4 months for 1 year, and then every 6 months for 3 years.
PROJECTED ACCRUAL: A total of 15-41 patients will be accrued for this study within 6-18 months.
Eligibility:
| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
DISEASE CHARACTERISTICS:
- Histologically or cytologically confirmed malignant pleural mesothelioma
-
At least 1 measurable lesion that can be accurately measured in at least one dimension
- At least 20 mm (2 cm) in diameter
PATIENT CHARACTERISTICS:
Age:
- 18 and over
Performance status:
- ECOG 0-2
Life expectancy:
- At least 12 weeks
Hematopoietic:
- Absolute neutrophil count at least 1,500/mm^3
- Platelet count at least 100,000/mm^3
Hepatic:
- Bilirubin no greater than 1.5 times upper limit of normal (ULN)
- AST no greater than 3 times ULN
Renal:
- Creatinine no greater than 1.5 times ULN
Cardiovascular:
- LVEF at least 50%
- No history of congestive heart failure
- No New York Heart Association class III or IV heart disease
Other:
- No uncontrolled infection
- No other severe underlying disease that would preclude study participation
- No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer, noninvasive carcinomas, or localized prostate cancer
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception during and for 6 months after study participation
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- Not specified
Chemotherapy:
- No more than 1 prior chemotherapy regimen for malignant pleural mesothelioma
- No prior gemcitabine or anthracyclines
Endocrine therapy:
- Not specified
Radiotherapy:
- Not specified
Surgery:
- Not specified
Other:
- No concurrent cimetidine
Contacts and Locations:
Please refer to this study by its ClinicalTrials.gov identifier: NCT00017186Locations
| United States, Alabama | |||||
| MBCCOP - Gulf Coast | |||||
| Mobile, Alabama, United States, 36607 | |||||
| United States, Arizona | |||||
| CCOP - Mayo Clinic Scottsdale Oncology Program | |||||
| Scottsdale, Arizona, United States, 85259-5404 | |||||
| United States, Florida | |||||
| Mayo Clinic - Jacksonville | |||||
| Jacksonville, Florida, United States, 32224 | |||||
| United States, Illinois | |||||
| CCOP - Carle Cancer Center | |||||
| Urbana, Illinois, United States, 61801 | |||||
| CCOP - Illinois Oncology Research Association | |||||
| Peoria, Illinois, United States, 61602 | |||||
| United States, Iowa | |||||
| CCOP - Cedar Rapids Oncology Project | |||||
| Cedar Rapids, Iowa, United States, 52403-1206 | |||||
| CCOP - Iowa Oncology Research Association | |||||
| Des Moines, Iowa, United States, 50309-1016 | |||||
| Siouxland Hematology-Oncology | |||||
| Sioux City, Iowa, United States, 51101-1733 | |||||
| United States, Kansas | |||||
| CCOP - Wichita | |||||
| Wichita, Kansas, United States, 67214-3882 | |||||
| United States, Louisiana | |||||
| CCOP - Ochsner | |||||
| New Orleans, Louisiana, United States, 70121 | |||||
| United States, Michigan | |||||
| CCOP - Michigan Cancer Research Consortium | |||||
| Ann Arbor, Michigan, United States, 48106 | |||||
| United States, Minnesota | |||||
| CCOP - Duluth | |||||
| Duluth, Minnesota, United States, 55805 | |||||
| CCOP - Metro-Minnesota | |||||
| Saint Louis Park, Minnesota, United States, 55416 | |||||
| Coborn Cancer Center | |||||
| Saint Cloud, Minnesota, United States, 56303 | |||||
| Mayo Clinic Cancer Center | |||||
| Rochester, Minnesota, United States, 55905 | |||||
| United States, Nebraska | |||||
| CCOP - Missouri Valley Cancer Consortium | |||||
| Omaha, Nebraska, United States, 68106 | |||||
| United States, North Dakota | |||||
| CCOP - Merit Care Hospital | |||||
| Fargo, North Dakota, United States, 58122 | |||||
| Medcenter One Health System | |||||
| Bismarck, North Dakota, United States, 58501-5505 | |||||
| United States, Ohio | |||||
| CCOP - Toledo Community Hospital | |||||
| Toledo, Ohio, United States, 43623-3456 | |||||
| United States, Pennsylvania | |||||
| CCOP - Geisinger Clinic and Medical Center | |||||
| Danville, Pennsylvania, United States, 17822-2001 | |||||
| United States, South Carolina | |||||
| CCOP - Upstate Carolina | |||||
| Spartanburg, South Carolina, United States, 29303 | |||||
| United States, South Dakota | |||||
| CCOP - Sioux Community Cancer Consortium | |||||
| Sioux Falls, South Dakota, United States, 57104 | |||||
| Rapid City Regional Hospital | |||||
| Rapid City, South Dakota, United States, 57709 | |||||
| United States, Wisconsin | |||||
| CCOP - St. Vincent Hospital Cancer Center, Green Bay | |||||
| Green Bay, Wisconsin, United States, 54301 | |||||
Sponsors and Collaborators
| North Central Cancer Treatment Group |
| National Cancer Institute (NCI) |
Investigators
| Study Chair: | Scott Okuno, MD | Mayo Clinic |
Additional Information:
Publications of Results:| Okuno SH, Delaune R, Sloan JA, Foster NR, Maurer MJ, Aubry MC, Rowland KM Jr, Soori GS, Nikcevich DA, Kardinal CG, Northfelt DW, Adjei AA. A phase 2 study of gemcitabine and epirubicin for the treatment of pleural mesothelioma : a North Central Cancer Treatment Study, N0021. Cancer. 2008 Jan 25; [Epub ahead of print] |
Other Publications:
| Huschka MM, Mandrekar SJ, Schaefer PL, Jett JR, Sloan JA. A pooled analysis of quality of life measures and adverse events data in north central cancer treatment group lung cancer clinical trials. Cancer. 2007 Jan 8;109(4):787-795 [Epub ahead of print] |
| Study ID Numbers: | CDR0000068659, NCCTG-N0021 |
| First Received: | June 6, 2001 |
| Last Updated: | January 30, 2008 |
| ClinicalTrials.gov Identifier: | NCT00017186 |
| Health Authority: | United States: Federal Government |
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