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A Randomized Phase 3 Study of the Efficacy and Safety of Glufosfamide Compared With Best Supportive Care in Metastatic Pancreatic Adenocarcinoma Previously Treated With Gemcitabine

Phase 3
18 Years
Not Enrolling
Pancreatic Cancer

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Trial Information

A Randomized Phase 3 Study of the Efficacy and Safety of Glufosfamide Compared With Best Supportive Care in Metastatic Pancreatic Adenocarcinoma Previously Treated With Gemcitabine

TH-CR-302 is a randomized Phase 3 study that will evaluate the efficacy and safety of
glufosfamide plus best supportive care (BSC) compared to BSC alone for second line treatment
of metastatic pancreatic cancer. BSC includes all medical or surgical interventions that a
pancreatic cancer patient should receive to palliate the cancer but excludes treatment with
systemic therapies intended to kill the cancer cells.

Study Hypothesis: Glufosfamide will provide benefits in survival to patients with
metastatic pancreatic cancer over best supportive care.

Comparison: Glufosfamide versus best supportive care.

Inclusion Criteria:

- 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

Exclusion Criteria:

- 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

- 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

- 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))

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Overall Survival


United States: Food and Drug Administration

Study ID:




Start Date:

September 2004

Completion Date:

January 2007

Related Keywords:

  • Pancreatic Cancer
  • Pancreas
  • Cancer
  • Pancreatic Adenocarcinoma
  • Metastatic
  • Glufosfamide
  • Adenocarcinoma
  • Pancreatic Neoplasms



West Michigan Cancer CenterKalamazoo, Michigan  49007-3731
Columbia Comprehensive Cancer Care ClinicColumbia, Missouri  65201
Bond ClinicRolla, Missouri  65401
Kenmar Research InstituteLos Angeles, California  90057
Center for Oncology Research and TreatmentDallas, Texas  75230
Northern Utah AssociatesOgden, Utah  84403
Deaconess Billings ClinicBillings, Montana  59107-5100
New Mexico Oncology Hematology ConsultantsAlbuquerque, New Mexico  87102
Marshfield Clinic Research FoundationMarshfield, Wisconsin  54449
Hematology/Oncology of the North ShoreSkokie, Illinois  60076
Mile High OncologyDenver, Colorado  80210
Augusta Oncology AssociatesLos Angeles, California  90057
Northwestern Connecticut Oncology - Hematology AssociatesTorrington, Connecticut  06790
Palm Beach Institute of Hematology and OncologyBoynton Beach, Florida  33435
Fort Wayne Medical Oncology/HemFort Wayne, Indiana  46815
Norton Healthcare CenterLouisville, Kentucky  40202
Hattiesburg Clinic OncologyHattiesburg, Mississippi  39401
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Hanover Medical SpecialistsWilmington, North Carolina  28401
Vita Hematology Oncology PCBethlehem, Pennsylvania  18015
The Family Cancer Center , PLLCCollierville, Tennessee  38017
JPS Center for Cancer CareFort Worth, Texas  76104
Cancer Outreach AssociationAbingdon, Virginia  24211