ONCONASE Plus Doxorubicin Versus Doxorubicin Alone For Patients With Malignant Pleural or Peritoneal Mesothelioma Who Have Had No More Than One Prior Chemotherapy Regimen
Recruitment status was Active, not recruiting
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Purpose
RATIONALE: Drugs used in chemotherapy work in different ways to stop tumor cells from dividing so they stop growing or die. It is not yet known whether Onconase plus doxorubicin is more effective than doxorubicin alone in treating patients with malignant mesothelioma.
PURPOSE: This randomized phase III trial is studying doxorubicin alone to see how well it works compared to doxorubicin and Onconase in treating patients with malignant mesothelioma.
| Condition | Intervention | Phase |
|---|---|---|
|
Malignant Mesothelioma |
Drug: doxorubicin hydrochloride Drug: ranpirnase |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Masking: Open Label Primary Purpose: Treatment |
| Official Title: | ONCONASE Plus Doxorubicin Versus Doxorubicin For Patients With Malignant Pleural or Peritoneal Mesothelioma Who Have Had No More Than One Prior Chemotherapy Regimen |
- Survival [ Designated as safety issue: No ]
- Objective response [ Designated as safety issue: No ]
- Time to best response [ Designated as safety issue: No ]
- Response duration [ Designated as safety issue: No ]
| Estimated Enrollment: | 300 |
| Study Start Date: | May 1997 |
| Estimated Primary Completion Date: | February 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Arm I
Patients receive ranpirnase IV over 30 minutes weekly followed by doxorubicin IV. Treatment repeats every 3 weeks for at least 6 courses in the absence of disease progression. Patients demonstrating evidence of clinical response or stable disease may continue on maintenance therapy with ranpirnase as a single agent until disease progression.
|
Drug: doxorubicin hydrochloride
Given IV
Drug: ranpirnase
Given IV
|
|
Experimental: Arm II
Patients receive doxorubicin as in arm I for up to 6 courses.
|
Drug: doxorubicin hydrochloride
Given IV
|
Detailed Description:
OBJECTIVES:
- Compare the efficacy of doxorubicin with or without ranpirnase in patients with malignant pleural or peritoneal mesothelioma.
- Compare the safety profile of these regimens in these patients.
- Compare the overall survival, progression-free survival, and quality of life of patients treated with these regimens.
OUTLINE: This is a randomized, open-label, controlled, multicenter study. Patients are stratified according to disease histology (epithelioid vs nonepithelioid) and CALGB groups 1-4. Patients are randomized to 1 of 2 treatment arms.
- Arm I: Patients receive ranpirnase IV over 30 minutes weekly followed by doxorubicin IV. Treatment repeats every 3 weeks for at least 6 courses in the absence of disease progression. Patients demonstrating evidence of clinical response or stable disease may continue on maintenance therapy with ranpirnase as a single agent until disease progression.
- Arm II: Patients receive doxorubicin as in arm I for up to 6 courses. Quality of life is assessed.
PROJECTED ACCRUAL: A minimum of 300 patients will be accrued for this study.
Eligibility| Ages Eligible for Study: | 21 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed malignant pleural or peritoneal mesothelioma
- Measurable or evaluable disease
- CALGB groups 1-4
- No CNS metastases
PATIENT CHARACTERISTICS:
Age:
- 21 and over
Performance status:
- ECOG 0-1
Life expectancy:
- Not specified
Hematopoietic:
- WBC greater than 3,500/mm^3
- Absolute neutrophil count at least 1,500/mm^3
- Platelet count at least 100,000/mm^3
Hepatic:
- SGOT no greater than 2 times upper limit of normal
- Bilirubin no greater than 2 mg/dL
- PT and PTT normal
Renal:
- Creatinine normal
Cardiovascular:
- No symptomatic New York Heart Association class II-IV cardiovascular disease
- No congestive heart failure
- No angina pectoris
- No cardiac arrhythmias
- No uncontrolled hypertension
- No cerebrovascular disease
Metabolic:
- No serum calcium, phosphate, electrolyte, or other metabolic abnormalities, such as metabolic acidosis
Other:
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- No serious infection
- No uncontrolled psychosis or neurologic disease (e.g., seizure disorders)
- No uncontrolled diabetes mellitus
- No other primary malignancy within the past 5 years except nonmelanoma skin cancer
- No senility or emotional instability
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- Not specified
Chemotherapy:
- No more than one prior systemic chemotherapy regimen
- No prior doxorubicin
- At least 6 weeks since prior chemotherapy
Endocrine therapy:
- Not specified
Radiotherapy:
- Prior radiotherapy for progressive or recurrent disease allowed except myocardium radiotherapy
Surgery:
- Prior surgical resection allowed
Contacts and Locations| United States, Indiana | |
| CCOP - Northern Indiana CR Consortium | |
| South Bend, Indiana, United States, 46601 | |
| United States, Maryland | |
| Greenebaum Cancer Center at University of Maryland Medical Center | |
| Baltimore, Maryland, United States, 21201 | |
| United States, Michigan | |
| Spectrum Health Hospital - Butterworth Campus | |
| Grand Rapids, Michigan, United States, 49503 | |
| United States, Minnesota | |
| CCOP - Duluth | |
| Duluth, Minnesota, United States, 55805-1983 | |
| United States, Missouri | |
| Missouri Cancer Care, PC at St. Joseph Health Center - St. Charles | |
| St. Charles, Missouri, United States, 63301 | |
| United States, Nebraska | |
| Methodist Estabrook Cancer Center | |
| Omaha, Nebraska, United States, 68114-4199 | |
| United States, New Mexico | |
| University of New Mexico Cancer Research and Treatment Center | |
| Albuquerque, New Mexico, United States, 87131-5636 | |
| Germany | |
| Asklepios Fachkliniken Muenchen-Gauting | |
| Gauting, Germany, D-82131 | |
| Hospital Grosshansdorf | |
| Grosshansdorf, Germany, D-22927 | |
| Asklepios Klinik Harburg | |
| Hamburg, Germany, D-21075 | |
| Asklepios Klinik St. Georg | |
| Hamburg, Germany, D-20099 | |
| Klinikum Rechts Der Isar - Technische Universitaet Muenchen | |
| Munich, Germany, D-81675 | |
| Italy | |
| Ospedale San Martino | |
| Genoa, Italy, 16132 | |
| Istituto Nazionale per la Ricerca sul Cancro | |
| Genoa, Italy, 16132 | |
| Fondazione I.R.C.C.S. Policlinico San Matteo | |
| Pavia, Italy, 27100 | |
| Poland | |
| Medical University of Gdansk | |
| Gdansk, Poland, 80-211 | |
| University School of Medical Sciences | |
| Poznan, Poland, PL-60 569 | |
| Maria Sklodowska-Curie Memorial Cancer Center and Institute of Oncology | |
| Warsaw, Poland, 02-781 | |
| Klinika Chrorob Pluc I Gruzlicy | |
| Zabrze, Poland, 41-803 | |
| Study Chair: | Diane Scudiery | Alfacell |
More Information
Additional Information:
No publications provided
| ClinicalTrials.gov Identifier: | NCT00003034 History of Changes |
| Other Study ID Numbers: | CDR0000065639, ALFACELL-P30-302, NCI-V97-1273 |
| Study First Received: | November 1, 1999 |
| Last Updated: | April 26, 2009 |
| Health Authority: | United States: Federal Government |
Keywords provided by National Cancer Institute (NCI):
|
localized malignant mesothelioma advanced malignant mesothelioma recurrent malignant mesothelioma |
Additional relevant MeSH terms:
|
Mesothelioma Adenoma Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms Neoplasms, Mesothelial Doxorubicin Ranpirnase |
Antibiotics, Antineoplastic Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Protein Synthesis Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |
ClinicalTrials.gov processed this record on May 23, 2013