ONCONASE Plus Doxorubicin Versus Doxorubicin Alone For Patients With Malignant Pleural or Peritoneal Mesothelioma Who Have Had No More Than One Prior Chemotherapy Regimen
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| ClinicalTrials.gov Identifier: NCT00003034 |
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Recruitment Status : Unknown
Verified October 2007 by National Cancer Institute (NCI).
Recruitment status was: Active, not recruiting
First Posted : January 27, 2003
Last Update Posted : November 6, 2013
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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 or disease | Intervention/treatment | Phase |
|---|---|---|
| Malignant Mesothelioma | Drug: doxorubicin hydrochloride Drug: ranpirnase | Phase 3 |
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.
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 300 participants |
| Allocation: | Randomized |
| Masking: | None (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 |
| Study Start Date : | May 1997 |
| Estimated Primary Completion Date : | February 2008 |
| Arm | Intervention/treatment |
|---|---|
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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.
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Drug: doxorubicin hydrochloride
Given IV Drug: ranpirnase Given IV |
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Experimental: Arm II
Patients receive doxorubicin as in arm I for up to 6 courses.
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Drug: doxorubicin hydrochloride
Given IV |
- Survival
- Objective response
- Time to best response
- Response duration
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| Ages Eligible for Study: | 21 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
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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
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): NCT00003034
Show 19 study locations
| Study Chair: | Diane Scudiery | Alfacell |
| ClinicalTrials.gov Identifier: | NCT00003034 |
| Other Study ID Numbers: |
CDR0000065639 ALFACELL-P30-302 NCI-V97-1273 |
| First Posted: | January 27, 2003 Key Record Dates |
| Last Update Posted: | November 6, 2013 |
| Last Verified: | October 2007 |
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localized malignant mesothelioma advanced malignant mesothelioma recurrent malignant mesothelioma |
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Mesothelioma Mesothelioma, Malignant Adenoma Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms Neoplasms, Mesothelial Lung Neoplasms Respiratory Tract Neoplasms Thoracic Neoplasms Neoplasms by Site Pleural Neoplasms |
Lung Diseases Respiratory Tract Diseases Doxorubicin Liposomal doxorubicin Ranpirnase Antibiotics, Antineoplastic Antineoplastic Agents Topoisomerase II Inhibitors Topoisomerase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Protein Synthesis Inhibitors |