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Gemcitabine and Epirubicin in Treating Patients With Malignant Mesothelioma

Sponsor
Alliance for Clinical Trials in Oncology (Other)
Overall Status
Completed
CT.gov ID
NCT00017186
Collaborator
National Cancer Institute (NCI) (NIH)
69
Enrollment
24
Locations
1
Arm
82
Duration (Months)
2.9
Patients Per Site
0
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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
  • Drug: epirubicin hydrochloride
  • Drug: gemcitabine hydrochloride
 Phase 2

Detailed Description

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 Design

Study Type:
Interventional
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 :
Jul 1, 2001
Actual Primary Completion Date :
Aug 1, 2004
Actual Study Completion Date :
May 1, 2008

Arms and Interventions

Arm Intervention/Treatment
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

Outcome Measures

Primary Outcome Measures

  1. time to progression [Up to 5 years]

Secondary Outcome Measures

  1. survival [Up to 5 years]

  2. quality of life [Up to 5 years]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
DISEASE CHARACTERISTICS:

  • Histologically or cytologically confirmed malignant pleural mesothelioma

  • 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

Contacts and Locations

Locations

Site City State Country Postal Code
1 MBCCOP - Gulf Coast Mobile Alabama United States 36607
2 CCOP - Mayo Clinic Scottsdale Oncology Program Scottsdale Arizona United States 85259-5404
3 Mayo Clinic - Jacksonville Jacksonville Florida United States 32224
4 CCOP - Illinois Oncology Research Association Peoria Illinois United States 61602
5 CCOP - Carle Cancer Center Urbana Illinois United States 61801
6 CCOP - Cedar Rapids Oncology Project Cedar Rapids Iowa United States 52403-1206
7 CCOP - Iowa Oncology Research Association Des Moines Iowa United States 50309-1016
8 Siouxland Hematology-Oncology Sioux City Iowa United States 51101-1733
9 CCOP - Wichita Wichita Kansas United States 67214-3882
10 CCOP - Ochsner New Orleans Louisiana United States 70121
11 CCOP - Michigan Cancer Research Consortium Ann Arbor Michigan United States 48106
12 CCOP - Duluth Duluth Minnesota United States 55805
13 Mayo Clinic Cancer Center Rochester Minnesota United States 55905
14 Coborn Cancer Center Saint Cloud Minnesota United States 56303
15 CCOP - Metro-Minnesota Saint Louis Park Minnesota United States 55416
16 CCOP - Missouri Valley Cancer Consortium Omaha Nebraska United States 68106
17 Medcenter One Health System Bismarck North Dakota United States 58501-5505
18 CCOP - Merit Care Hospital Fargo North Dakota United States 58122
19 CCOP - Toledo Community Hospital Toledo Ohio United States 43623-3456
20 CCOP - Geisinger Clinic and Medical Center Danville Pennsylvania United States 17822-2001
21 CCOP - Upstate Carolina Spartanburg South Carolina United States 29303
22 Rapid City Regional Hospital Rapid City South Dakota United States 57709
23 CCOP - Sioux Community Cancer Consortium Sioux Falls South Dakota United States 57104
24 CCOP - St. Vincent Hospital Cancer Center, Green Bay Green Bay Wisconsin United States 54301

Sponsors and Collaborators

  • Alliance for Clinical Trials in Oncology
  • National Cancer Institute (NCI)

Investigators

  • Study Chair: Scott Okuno, MD, Mayo Clinic

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Alliance for Clinical Trials in Oncology
ClinicalTrials.gov Identifier:
NCT00017186
Other Study ID Numbers:
  • NCCTG-N0021
  • NCCTG-N0021
  • CDR0000068659
First Posted:
Jan 27, 2003
Last Update Posted:
Dec 7, 2016
Last Verified:
Dec 1, 2016
Keywords provided by Alliance for Clinical Trials in Oncology
localized malignant mesothelioma
advanced malignant mesothelioma
recurrent malignant mesothelioma
Additional relevant MeSH terms:
Mesothelioma
Mesothelioma, Malignant
Lung Neoplasms
Gemcitabine
Epirubicin

Study Results

No Results Posted as of Dec 7, 2016