Study of the Efficacy and Safety of Glufosfamide Compared With Best Supportive Care in Metastatic Pancreatic Cancer

Completed · Phase 3

Conditions studied: Pancreatic Cancer

In brief

The primary objectives of the study is to evaluate the effectiveness and safety of glufosfamide in subjects with pancreatic cancer who have been previously treated with gemcitabine as measured by overall survival compared with best supportive care.

Key facts

Study ID

NCT00099294

Run by

Threshold Pharmaceuticals

People needed

300

Starts

2004-09-01

Expected to finish

2007-01-01

Last updated by the study team

2009-04-30

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• At least 18 years of age
• Pancreatic adenocarcinoma proven either by histology (surgical biopsy) or cytology (CT- or endoscopic-guided)
• Metastatic pancreatic cancer
• Disease progression during or after treatment with gemcitabine (alone or in combination with other agents; at regular, not radiosensitizing, doses) for advanced/metastatic pancreatic cancer
• Measurable or nonmeasurable disease by RECIST criteria (at least one target or nontarget lesion)
• Recovered from reversible toxicities of prior therapy
• Karnofsky performance status ≥70
• All women of childbearing potential and all men must agree to use effective means of contraception (surgical sterilization or the use of barrier contraception with either a condom or diaphragm in conjunction with spermicidal gel or an IUD) from entry into the study through 6 months after the last dose
• Ability to understand the purposes and risks of the study and has signed a written informed consent form approved by the investigator's IRB/Ethics Committee

You may not qualify if…

• More than one prior systemic therapy regimen for metastatic/locally advanced pancreatic cancer (radiosensitizing doses of 5FU or gemcitabine at the time of initial radiotherapy do not count as a prior systemic therapy regimen)
• Hormonal therapy, radiation therapy, biologic therapy, chemotherapy or other systemic antitumor therapy for pancreatic cancer within 14 days prior to study start
• Symptomatic brain metastases (baseline CT scan is not required in asymptomatic subjects)
• Active clinically significant infection requiring antibiotics
• Known HIV positive or active hepatitis B or C
• Recent (one year) history or symptoms of cardiovascular disease (NYHA Class 2, 3, or 4), particularly coronary artery disease, arrhythmias or conduction defects with risk of cardiovascular instability, uncontrolled hypertension, clinically significant pericardial effusion, or congestive heart failure
• No other active malignancies (other than treated non-melanoma skin cancer or treated in situ cancer) within the past year
• Major surgery within 3 weeks of the start of study treatment, without complete recovery
• Clinically significant abnormalities in laboratory test results (including complete blood count, chemistry panel including electrolytes, and urinalysis) (Hemoglobin <9 g/dL (may receive transfusion or erythropoietin to maintain))

Where it is running

• Kenmar Research Institute — Los Angeles, California, United States
• Mile High Oncology — Denver, Colorado, United States
• Northwestern Connecticut Oncology - Hematology Associates — Torrington, Connecticut, United States
• Palm Beach Institute of Hematology and Oncology — Boynton Beach, Florida, United States
• Hematology/Oncology of the North Shore — Skokie, Illinois, United States
• Fort Wayne Medical Oncology/Hem — Fort Wayne, Indiana, United States
• Norton Healthcare Center — Louisville, Kentucky, United States
• West Michigan Cancer Center — Kalamazoo, Michigan, United States
• Hattiesburg Clinic Oncology — Hattiesburg, Mississippi, United States
• Columbia Comprehensive Cancer Care Clinic — Columbia, Missouri, United States
• Bond Clinic — Rolla, Missouri, United States
• Deaconess Billings Clinic — Billings, Montana, United States
• Office of Clinical Trials — Paramus, New Jersey, United States
• New Mexico Oncology Hematology Consultants — Albuquerque, New Mexico, United States
• Hanover Medical Specialists — Wilmington, North Carolina, United States
• Vita Hematology Oncology PC — Bethlehem, Pennsylvania, United States
• The Family Cancer Center , PLLC — Collierville, Tennessee, United States
• Center for Oncology Research and Treatment — Dallas, Texas, United States
• JPS Center for Cancer Care — Fort Worth, Texas, United States
• Northern Utah Associates — Ogden, Utah, United States
• Cancer Outreach Association — Abingdon, Virginia, United States
• Marshfield Clinic Research Foundation — Marshfield, Wisconsin, United States
• Hospital Interzonal General de Agudos — Buenos Aires, Argentina
• Hospital Posadas — Buenos Aires, Argentina
• Augusta Oncology Associates — Los Angeles, California, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.