Study of Safety and Efficacy of Glufosfamide in Combination With Gemcitabine in Cancer

This study has been completed.
Sponsor:
Collaborator:
PPD
Information provided by:
Threshold Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00102752
First received: February 1, 2005
Last updated: April 28, 2009
Last verified: April 2009
  Purpose

The purpose of this study is to determine the safety of glufosfamide when administered in combination with gemcitabine.


Condition Intervention Phase
Neoplasms
Pancreatic Neoplasms
Drug: Glufosfamide
Drug: Gemcitabine
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase 1/2 Dose-Escalation Study of the Safety, Efficacy and Pharmacokinetics of Glufosfamide in Combination With Gemcitabine in Advanced Solid Tumors and Pancreatic Adenocarcinoma

Resource links provided by NLM:


Further study details as provided by Threshold Pharmaceuticals:

Primary Outcome Measures:
  • Overall objective response rate

Secondary Outcome Measures:
  • Overall survival
  • 6- and 12- month survival
  • Progression-free survival
  • Duration of objective response
  • Serum CA-19-9

Estimated Enrollment: 47
Study Start Date: December 2004
Study Completion Date: July 2007
Primary Completion Date: July 2007 (Final data collection date for primary outcome measure)
Detailed Description:

This study, TH-CR-301, is a Phase 1/2 study that will evaluate the efficacy and safety of glufosfamide in combination with gemcitabine in advanced solid tumors or in first line treatment of pancreatic cancer.

Study Hypothesis: Glufosfamide in combination with gemcitabine may provide benefits in survival to patients with advanced solid tumors or metastatic pancreatic cancer.

  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
  • Histologically or cytologically confirmed, locally advanced or metastatic solid malignancy; previously treated with at least one chemotherapy regimen for advanced or metastatic disease or no effective standard treatment is available OR
  • Metastatic and/or locally advanced, inoperable pancreatic adenocarcinoma proven either by histology (surgical biopsy) or cytology (CT- or endoscopic-guided)
  • 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
  • Women of childbearing potential and men to use effective means of contraception from entry into the study through 6 months after the last dose
  • Ability to understand the purposes and risks of the study and provide written informed consent.

Exclusion Criteria:

  • Prior chemotherapy for metastatic/locally advanced pancreatic cancer
  • Prior administration of gemcitabine
  • Radiation therapy within 28 days prior to study start
  • Hormonal therapy, biologic therapy, chemotherapy or other systemic anti-tumor therapy for cancer within 21 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
  • History or symptoms of cardiovascular disease (NYHA Class 3 or 4)
  • Other primary malignancies (other than treated non-melanoma skin cancer or treated in situ cancer) within the past 5 years
  • 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),
    • ANC <1500/μL,
    • Platelet count <100,000/μL,
    • Total bilirubin > 1.5 ×ULN,
    • AST/ALT > 2.5-fold above ULN (>5-fold above ULN if liver metastases),
    • Serum creatinine > 2 mg/dL,
    • Creatinine clearance < 60 mL/min (calculated)
  • Females who are pregnant or breast-feeding
  • Participation in an investigational drug or device study within 28 days of the first day of dosing on this study
  • Concomitant disease or condition that could interfere with the conduct of the study
  • Unwillingness or inability to comply with the study protocol for any other reason
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00102752

Locations
United States, Arizona
Arizona Cancer Center
Tucson, Arizona, United States, 85724
United States, Indiana
Indiana Cancer Center
Indianapolis, Indiana, United States, 46202
United States, Kentucky
Norton Healthcare Cancer Center
Louisville, Kentucky, United States, 40202
Brazil
Hospital de Doenças Cardiovasculares - Biocor
Nova Lima, BH, Brazil, 34000-000
Hospital Nossa Senhora da Conceição
Porto Alegre, RS, Brazil, 91350-200
Hospital Mãe de Deus
Porto Alegre, RS, Brazil, 90880-480
Fundação Pio XII - Hospital de Câncer de Barretos
Barretos, SP, Brazil, 14784-400
Universidade Federal de São Paulo - Hospital São Paulo
São Paulo, SP, Brazil, 04023-900
Hospital Israelita Albert Einstein
São Paulo, SP, Brazil, 05651-901
Sponsors and Collaborators
Threshold Pharmaceuticals
PPD
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00102752     History of Changes
Other Study ID Numbers: TH-CR-301
Study First Received: February 1, 2005
Last Updated: April 28, 2009
Health Authority: United States: Food and Drug Administration

Keywords provided by Threshold Pharmaceuticals:
Pancreas
Cancer
Metastatic
Glufosfamide
Advanced
Solid
Tumor
Advanced Solid Tumors
Pancreatic Adenocarcinoma

Additional relevant MeSH terms:
Adenocarcinoma
Neoplasms
Pancreatic Neoplasms
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Digestive System Neoplasms
Neoplasms by Site
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases
Gemcitabine
Ifosfamide
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Radiation-Sensitizing Agents
Antineoplastic Agents, Alkylating
Alkylating Agents

ClinicalTrials.gov processed this record on July 26, 2014