Gemcitabine and Epirubicin in Treating Patients With Malignant Mesothelioma

NCT00017186 | Completed Phase 2 DMC

• 2 other identifiers: NCCTG-N0021CDR0000068659
• Study Type: interventional
• Target: 69
• Locations: 1 country
• Sites: 24

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.

Conditions

Malignant Mesothelioma

Keywords

localized malignant mesothelioma; advanced malignant mesothelioma; recurrent malignant mesothelioma

Outcome Measures

Primary Outcomes (1)

• time to progression

  Up to 5 years

Secondary Outcomes (2)

• survival

  Up to 5 years

• quality of life

  Up to 5 years

Study Arms (1)

gemcitabine + epirubicin

EXPERIMENTAL

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

Interventions

epirubicin hydrochloride DRUG

gemcitabine + epirubicin

gemcitabine hydrochloride DRUG

gemcitabine + epirubicin

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

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

Study Sites (24)

MBCCOP - Gulf Coast

Mobile, Alabama, 36607, United States

Location

CCOP - Mayo Clinic Scottsdale Oncology Program

Scottsdale, Arizona, 85259-5404, United States

Location

Mayo Clinic - Jacksonville

Jacksonville, Florida, 32224, United States

Location

CCOP - Illinois Oncology Research Association

Peoria, Illinois, 61602, United States

Location

CCOP - Carle Cancer Center

Urbana, Illinois, 61801, United States

Location

CCOP - Cedar Rapids Oncology Project

Cedar Rapids, Iowa, 52403-1206, United States

Location

CCOP - Iowa Oncology Research Association

Des Moines, Iowa, 50309-1016, United States

Location

Siouxland Hematology-Oncology

Sioux City, Iowa, 51101-1733, United States

Location

CCOP - Wichita

Wichita, Kansas, 67214-3882, United States

Location

CCOP - Ochsner

New Orleans, Louisiana, 70121, United States

Location

CCOP - Michigan Cancer Research Consortium

Ann Arbor, Michigan, 48106, United States

Location

CCOP - Duluth

Duluth, Minnesota, 55805, United States

Location

Mayo Clinic Cancer Center

Rochester, Minnesota, 55905, United States

Location

Coborn Cancer Center

Saint Cloud, Minnesota, 56303, United States

Location

CCOP - Metro-Minnesota

Saint Louis Park, Minnesota, 55416, United States

Location

CCOP - Missouri Valley Cancer Consortium

Omaha, Nebraska, 68106, United States

Location

Medcenter One Health System

Bismarck, North Dakota, 58501-5505, United States

Location

CCOP - Merit Care Hospital

Fargo, North Dakota, 58122, United States

Location

CCOP - Toledo Community Hospital

Toledo, Ohio, 43623-3456, United States

Location

CCOP - Geisinger Clinic and Medical Center

Danville, Pennsylvania, 17822-2001, United States

Location

CCOP - Upstate Carolina

Spartanburg, South Carolina, 29303, United States

Location

Rapid City Regional Hospital

Rapid City, South Dakota, 57709, United States

Location

CCOP - Sioux Community Cancer Consortium

Sioux Falls, South Dakota, 57104, United States

Location

CCOP - St. Vincent Hospital Cancer Center, Green Bay

Green Bay, Wisconsin, 54301, United States

Location

Related Publications (2)

• Huschka MM, Mandrekar SJ, Schaefer PL, Jett JR, Sloan JA. A pooled analysis of quality of life measures and adverse events data in north central cancer treatment group lung cancer clinical trials. Cancer. 2007 Feb 15;109(4):787-95. doi: 10.1002/cncr.22444.

  PMID: 17211864 BACKGROUND

• Okuno SH, Delaune R, Sloan JA, Foster NR, Maurer MJ, Aubry MC, Rowland KM Jr, Soori GS, Nikcevich DA, Kardinal CG, Northfelt DW, Adjei AA; North Central Cancer Treatment Group. A phase 2 study of gemcitabine and epirubicin for the treatment of pleural mesothelioma: a North Central Cancer Treatment Study, N0021. Cancer. 2008 Apr 15;112(8):1772-9. doi: 10.1002/cncr.23313.

  PMID: 18224661 RESULT

MeSH Terms

Conditions

Mesothelioma, Malignant

Interventions

Epirubicin; Gemcitabine

Condition Hierarchy (Ancestors)

Mesothelioma; 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

Intervention Hierarchy (Ancestors)

Doxorubicin; Daunorubicin; Anthracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds; Aminoglycosides; Glycosides; Carbohydrates; Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring

Study Officials

• Scott Okuno, MD

  Mayo Clinic

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 6, 2001
• First Posted: January 27, 2003
• Study Start: July 1, 2001
• Primary Completion: August 1, 2004
• Study Completion: May 1, 2008
• Last Updated: December 7, 2016

Record last verified: 2016-12

Locations

US (24)