Nolatrexed Dihydrochloride Compared With Doxorubicin in Treating Patients With Recurrent or Unresectable Liver Cancer

NCT00012324 | Completed Phase 3

• 3 other identifiers: ZARIX-ZX101-301CDR0000068506AG-337-301
• Study Type: interventional
• Target: N/A
• Locations: 3 countries
• Sites: 42

Brief Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. It is not yet known which chemotherapy regimen is more effective for liver cancer. PURPOSE: Randomized phase III trial to compare the effectiveness of two different chemotherapy regimens in treating patients who have recurrent or unresectable liver cancer.

Conditions

Liver Cancer

Keywords

localized unresectable adult primary liver cancer; advanced adult primary liver cancer; recurrent adult primary liver cancer; adult primary hepatocellular carcinoma

Outcome Measures

Primary Outcomes (1)

• Overall survival

Secondary Outcomes (6)

• Time to progression

• Time to treatment failure

• Response rate (complete response, partial response, stable disease)

• Survival probabilities at 3, 6, 9, and 12 months

• Safety

Interventions

doxorubicin hydrochloride DRUG

nolatrexed dihydrochloride DRUG

Eligibility Criteria

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

DISEASE CHARACTERISTICS: * Histologically or cytologically proven or presumptive diagnosis of hepatocellular carcinoma * Presumptive diagnosis based on rising alpha-fetoprotein (AFP) levels over 2 assessments, CT scan or MRI of liver, spiral CT scan of portal/splenic vein, and biopsy evidence of cirrhosis * Unresectable or recurrent disease after prior surgical resection or embolization therapy * Fibrolamellar histology allowed if considered surgically unresectable based on tumor size, extrahepatic involvement, or multiple lobe involvement * CLIP (Cancer of the Liver Italian Program) score less than 4 * Concurrent assignment to a transplantation list allowed PATIENT CHARACTERISTICS: Age: * 18 and over Performance status: * Karnofsky 60-100% Life expectancy: * Not specified Hematopoietic: * Absolute neutrophil count at least 1,200/mm\^3 * Platelet count at least 80,000/mm\^3 Hepatic: * Bilirubin no greater than 3.0 mg/dL (except for known Gilbert's Syndrome) * AST no greater than 5 times upper limit of normal (ULN) * PT no greater than 1.5 times ULN Renal: * Creatinine no greater than 2.0 mg/dL Cardiovascular: * No uncontrolled hypertension within the past 3 months * No unstable angina, symptomatic congestive heart failure, or myocardial infarction within the past 3 months * No uncontrolled cardiac arrhythmia Other: * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception * No active bacterial infections * HIV negative * No AIDS * No other primary malignancy except carcinoma in situ of the cervix or urinary bladder or non-melanoma skin cancer * No mental incapacitation or psychiatric illness that would preclude study participation * No other severe disease that would preclude study participation * Candidate for placement of a central venous access device PRIOR CONCURRENT THERAPY: Biologic therapy: * Prior biologic therapy allowed * No concurrent biologic therapy Chemotherapy: * No prior IV doxorubicin except intraarterial administration in locoregional therapy Endocrine therapy: * Prior endocrine therapy allowed * No concurrent endocrine therapy Radiotherapy: * Prior radiotherapy allowed * No concurrent radiotherapy Surgery: * See Disease Characteristics * Surgery allowed if previously unresectable lesions become resectable * Recovered from any prior surgery * No concurrent liver transplantation Other: * No other concurrent investigational or marketed anticancer drugs * No other concurrent therapy for hepatocellular carcinoma * No concurrent terfenadine, astemizole, or cisapride that may not be interrupted during nolatrexed dihydrochloride administration

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

Sponsors & Collaborators

• Eximias Pharmaceutical: lead

Study Sites (42)

Arizona Clinical Research Center, Incorporated

Tucson, Arizona, 85715, United States

Location

Arkansas Cancer Research Center at University of Arkansas for Medical Sciences

Little Rock, Arkansas, 72205, United States

Location

Tower Cancer Research Foundation

Beverly Hills, California, 90211, United States

Location

Scripps Cancer Center at Scripps Clinic

La Jolla, California, 92037, United States

Location

David and Donna Long Center for Cancer Treatment at Sharp Grossmont Hospital

La Mesa, California, 91942, United States

Location

Veterans Affairs Medical Center - Long Beach

Long Beach, California, 90822, United States

Location

California Pacific Medical Center - Pacific Campus

San Francisco, California, 94115, United States

Location

Olive View - UCLA Medical Center Foundation

Sylmar, California, 91342, United States

Location

California Hematology/Oncology Medical Group

Torrance, California, 90505, United States

Location

Helen F. Graham Cancer Center

Newark, Delaware, 19713, United States

Location

Lombardi Cancer Center at Georgetown University Medical Center

Washington D.C., District of Columbia, 20007, United States

Location

Florida Cancer Institute - Bayonet Point

Hudson, Florida, 34667, United States

Location

University of Miami Sylvester Comprehensive Cancer Center

Miami, Florida, 33136, United States

Location

Oncology-Hematology Group of South Florida, P.A.

Miami, Florida, 33176, United States

Location

Ocala Research Institute, Incorporated

Ocala, Florida, 34480, United States

Location

Cancer Research Center of Hawaii

Honolulu, Hawaii, 96813, United States

Location

Robert H. Lurie Comprehensive Cancer Center at Northwestern University

Chicago, Illinois, 60611, United States

Location

University of Illinois at Chicago Cancer Center

Chicago, Illinois, 60612, United States

Location

Holden Comprehensive Cancer Center at University of Iowa

Iowa City, Iowa, 52242-1009, United States

Location

Louisiana Oncology Associates - Lafayette

Lafayette, Louisiana, 70506, United States

Location

Stanley S. Scott Cancer Center at Louisiana State University Medical Center - New Orleans

New Orleans, Louisiana, 70112, United States

Location

Alvin and Lois Lapidus Cancer Institute at Sinai Hospital

Baltimore, Maryland, 21215, United States

Location

University of Minnesota Cancer Center

Minneapolis, Minnesota, 55455, United States

Location

Saint Louis University Cancer Center

St Louis, Missouri, 63110, United States

Location

Siteman Cancer Center at Barnes-Jewish Hospital

St Louis, Missouri, 63110, United States

Location

UNMC Eppley Cancer Center at the University of Nebraska Medical Center

Omaha, Nebraska, 68198-7680, United States

Location

Hackensack University Medical Center

Hackensack, New Jersey, 07601, United States

Location

Veterans Affairs Medical Center - Albuquerque

Albuquerque, New Mexico, 87108, United States

Location

New York Weill Cornell Cancer Center at Cornell University

New York, New York, 10021, United States

Location

Herbert Irving Comprehensive Cancer Center at Columbia University

New York, New York, 10032, United States

Location

SUNY Upstate Medical University Hospital

Syracuse, New York, 13210, United States

Location

Albert Einstein Cancer Center at Albert Einstein College of Medicine

The Bronx, New York, 10467, United States

Location

New York Medical College

Valhalla, New York, 10595, United States

Location

Cleveland Clinic Taussig Cancer Center

Cleveland, Ohio, 44111, United States

Location

Albert Einstein Cancer Center

Philadelphia, Pennsylvania, 19141, United States

Location

Cancer Centers of the Carolinas - Eastside

Greenville, South Carolina, 29615, United States

Location

Medical City Dallas Hospital

Dallas, Texas, 75230, United States

Location

Joe Arrington Cancer Research and Treatment Center

Lubbock, Texas, 79410-1894, United States

Location

St. Boniface General Hospital

Winnipeg, Manitoba, R2H 2A6, Canada

Location

Ottawa Hospital Regional Cancer Centre - General Campus

Ottawa, Ontario, K1H 8L6, Canada

Location

Princess Margaret Hospital

Toronto, Ontario, M5G 2M9, Canada

Location

Fundacion de Investagacion De Diego

Santurce, 00909, Puerto Rico

Location

Related Publications (1)

• Gish RG, Porta C, Lazar L, Ruff P, Feld R, Croitoru A, Feun L, Jeziorski K, Leighton J, Gallo J, Kennealey GT. Phase III randomized controlled trial comparing the survival of patients with unresectable hepatocellular carcinoma treated with nolatrexed or doxorubicin. J Clin Oncol. 2007 Jul 20;25(21):3069-75. doi: 10.1200/JCO.2006.08.4046.

  PMID: 17634485 RESULT

MeSH Terms

Conditions

Liver Neoplasms; Carcinoma, Hepatocellular

Interventions

Doxorubicin; nolatrexed

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Liver Diseases; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type

Intervention Hierarchy (Ancestors)

Daunorubicin; Anthracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds; Aminoglycosides; Glycosides; Carbohydrates

Study Officials

• Gregory R. Suplick

  Eximias Pharmaceutical

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: March 3, 2001
• First Posted: January 27, 2003
• Study Start: September 1, 2000
• Study Completion: November 1, 2005
• Last Updated: June 26, 2013

Record last verified: 2005-10

Locations

US (38); CA (3); PR (1)