Gemcitabine and Epirubicin in Treating Patients With Malignant Mesothelioma
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| ClinicalTrials.gov Identifier: NCT00017186 |
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Recruitment Status :
Completed
First Posted : January 27, 2003
Last Update Posted : December 7, 2016
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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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Malignant Mesothelioma | Drug: epirubicin hydrochloride Drug: gemcitabine hydrochloride | Phase 2 |
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.
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 69 participants |
| Allocation: | N/A |
| Intervention Model: | Single Group Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| Official Title: | Phase II Study of Gemcitabine and Epirubicin for the Treatment of Mesothelioma |
| Study Start Date : | July 2001 |
| Actual Primary Completion Date : | August 2004 |
| Actual Study Completion Date : | May 2008 |
| Arm | Intervention/treatment |
|---|---|
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Experimental: gemcitabine + epirubicin
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. |
Drug: epirubicin hydrochloride Drug: gemcitabine hydrochloride |
- time to progression [ Time Frame: Up to 5 years ]
- survival [ Time Frame: Up to 5 years ]
- quality of life [ Time Frame: Up to 5 years ]
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
- Histologically or cytologically confirmed malignant pleural mesothelioma
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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:
Chemotherapy:
- No more than 1 prior chemotherapy regimen for malignant pleural mesothelioma
- No prior gemcitabine or anthracyclines
Other:
- No concurrent cimetidine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00017186
Show 24 study locations
| Study Chair: | Scott Okuno, MD | Mayo Clinic |
Other Publications:
| Responsible Party: | Alliance for Clinical Trials in Oncology |
| ClinicalTrials.gov Identifier: | NCT00017186 |
| Other Study ID Numbers: |
NCCTG-N0021 NCCTG-N0021 CDR0000068659 ( Registry Identifier: NCI Physician Data Query ) |
| First Posted: | January 27, 2003 Key Record Dates |
| Last Update Posted: | December 7, 2016 |
| Last Verified: | December 2016 |
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localized malignant mesothelioma advanced malignant mesothelioma recurrent malignant mesothelioma |
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Mesothelioma Mesothelioma, Malignant Lung Neoplasms Adenoma Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms Neoplasms, Mesothelial Respiratory Tract Neoplasms Thoracic Neoplasms Neoplasms by Site Pleural Neoplasms |
Lung Diseases Respiratory Tract Diseases Gemcitabine Epirubicin Antimetabolites, Antineoplastic Antimetabolites Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Antibiotics, Antineoplastic Topoisomerase II Inhibitors Topoisomerase Inhibitors Enzyme Inhibitors |