Clinical trial NCT00003034: ONCONASE Plus Doxorubicin Versus Doxorubicin Alone For Patients With Malignant Pleural or Peritoneal Mesothelioma Who Have Had No More Than One Prior Chemotherapy Regimen
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 type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Malignant Mesothelioma
Keywords: localized malignant mesothelioma
advanced malignant mesothelioma
recurrent malignant mesothelioma
Lead sponsor: National Cancer Institute (NCI)
Sponsor class: NIH
First posted: 2003-01-27
Enrollment: 300
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Primary purpose: TREATMENT

Brief summary: 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.

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 criteria: 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

Primary outcomes:
measure: Survival
Secondary outcomes:
measure: Objective response
measure: Time to best response
measure: Response duration
Other outcomes:
Locations:
city: South Bend
country: United States
facility: CCOP - Northern Indiana CR Consortium
state: Indiana
city: Baltimore
country: United States
facility: Greenebaum Cancer Center at University of Maryland Medical Center
state: Maryland
city: Grand Rapids
country: United States
facility: Spectrum Health Hospital - Butterworth Campus
state: Michigan
city: Duluth
country: United States
facility: CCOP - Duluth
state: Minnesota
city: St. Charles
country: United States
facility: Missouri Cancer Care, PC at St. Joseph Health Center - St. Charles
state: Missouri
city: Omaha
country: United States
facility: Methodist Estabrook Cancer Center
state: Nebraska
city: Albuquerque
country: United States
facility: University of New Mexico Cancer Research and Treatment Center
state: New Mexico
city: Gauting
country: Germany
facility: Asklepios Fachkliniken Muenchen-Gauting
city: Grosshansdorf
country: Germany
facility: Hospital Grosshansdorf
city: Hamburg
country: Germany
facility: Asklepios Klinik St. Georg
city: Hamburg
country: Germany
facility: Asklepios Klinik Harburg
city: Munich
country: Germany
facility: Klinikum Rechts Der Isar - Technische Universitaet Muenchen
city: Genoa
country: Italy
facility: Istituto Nazionale per la Ricerca sul Cancro
city: Genoa
country: Italy
facility: Ospedale San Martino
city: Pavia
country: Italy
facility: Fondazione I.R.C.C.S. Policlinico San Matteo
city: Gdansk
country: Poland
facility: Medical University of Gdansk
city: Poznan
country: Poland
facility: University School of Medical Sciences
city: Warsaw
country: Poland
facility: Maria Sklodowska-Curie Memorial Cancer Center and Institute of Oncology
city: Zabrze
country: Poland
facility: Klinika Chrorob Pluc I Gruzlicy
Study officials:
affiliation: Alfacell
name: Diane Scudiery
role: STUDY_CHAIR
References: