ONCONASE Plus Doxorubicin Versus Doxorubicin Alone For Patients With Malignant Pleural or Peritoneal Mesothelioma Who Have Had No More Than One Prior Chemotherapy Regimen

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2007 by National Cancer Institute (NCI).
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00003034
First received: November 1, 1999
Last updated: November 5, 2013
Last verified: October 2007

November 1, 1999
November 5, 2013
May 1997
February 2008   (final data collection date for primary outcome measure)
Survival [ Designated as safety issue: No ]
Not Provided
Complete list of historical versions of study NCT00003034 on ClinicalTrials.gov Archive Site
  • Objective response [ Designated as safety issue: No ]
  • Time to best response [ Designated as safety issue: No ]
  • Response duration [ Designated as safety issue: No ]
Not Provided
Not Provided
Not Provided
 
ONCONASE Plus Doxorubicin Versus Doxorubicin Alone For Patients With Malignant Pleural or Peritoneal Mesothelioma Who Have Had No More Than One Prior Chemotherapy Regimen
ONCONASE Plus Doxorubicin Versus Doxorubicin For Patients With Malignant Pleural or Peritoneal Mesothelioma Who Have Had No More Than One Prior Chemotherapy Regimen

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.

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.

Interventional
Phase 3
Allocation: Randomized
Masking: Open Label
Primary Purpose: Treatment
Malignant Mesothelioma
  • Drug: doxorubicin hydrochloride
    Given IV
  • Drug: ranpirnase
    Given IV
  • 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.
    Interventions:
    • Drug: doxorubicin hydrochloride
    • Drug: ranpirnase
  • Experimental: Arm II
    Patients receive doxorubicin as in arm I for up to 6 courses.
    Intervention: Drug: doxorubicin hydrochloride
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
300
Not Provided
February 2008   (final data collection date for primary outcome measure)

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
Both
21 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Germany,   United States,   Italy,   Poland
 
NCT00003034
CDR0000065639, ALFACELL-P30-302, NCI-V97-1273
Not Provided
Not Provided
Alfacell
Not Provided
Study Chair: Diane Scudiery Alfacell
National Cancer Institute (NCI)
October 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP