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

This study has been completed.
Sponsor:
Collaborator:
PPD
Information provided by:
Threshold Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00099294
First received: December 10, 2004
Last updated: April 28, 2009
Last verified: April 2009
  Purpose

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.


Condition Intervention Phase
Pancreatic Cancer
Drug: Glufosfamide
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Threshold Pharmaceuticals:

Primary Outcome Measures:
  • Overall Survival

Secondary Outcome Measures:
  • Objective tumor response rate
  • Duration of objective tumor response rate
  • Progression-free survival
  • 6 month and 12 month survival
  • Serum CA 19-9
  • Pain Intensity
  • Performance Status

Estimated Enrollment: 300
Study Start Date: September 2004
Study Completion Date: January 2007
Primary Completion Date: January 2007 (Final data collection date for primary outcome measure)
Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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 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))
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00099294

  Show 111 Study Locations
Sponsors and Collaborators
Threshold Pharmaceuticals
PPD
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00099294     History of Changes
Other Study ID Numbers: TH-CR-302
Study First Received: December 10, 2004
Last Updated: April 28, 2009
Health Authority: United States: Food and Drug Administration

Keywords provided by Threshold Pharmaceuticals:
Pancreas
Cancer
Pancreatic Adenocarcinoma
Metastatic
Glufosfamide

Additional relevant MeSH terms:
Adenocarcinoma
Pancreatic Neoplasms
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases
Ifosfamide
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on April 17, 2014