NCT00102752

Brief Summary

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

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
47

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Dec 2004

Typical duration for phase_1

Geographic Reach
2 countries

9 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2004

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

February 1, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 2, 2005

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2007

Completed
Last Updated

April 30, 2009

Status Verified

April 1, 2009

Enrollment Period

2.6 years

First QC Date

February 1, 2005

Last Update Submit

April 28, 2009

Conditions

NeoplasmsPancreatic Neoplasms

Keywords

PancreasCancerMetastaticGlufosfamideAdvancedSolidTumorAdvanced Solid TumorsPancreatic Adenocarcinoma

Outcome Measures

Primary Outcomes (1)

  • Overall objective response rate

Secondary Outcomes (5)

  • Overall survival

  • 6- and 12- month survival

  • Progression-free survival

  • Duration of objective response

  • Serum CA-19-9

Interventions

GlufosfamideDRUG
GemcitabineDRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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,
  • +7 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (9)

Arizona Cancer Center

Tucson, Arizona, 85724, United States

Location

Indiana Cancer Center

Indianapolis, Indiana, 46202, United States

Location

Norton Healthcare Cancer Center

Louisville, Kentucky, 40202, United States

Location

Hospital de Doenças Cardiovasculares - Biocor

Nova Lima, BH, 34000-000, Brazil

Location

Hospital Mãe de Deus

Porto Alegre, Rio Grande do Sul, 90880-480, Brazil

Location

Hospital Nossa Senhora da Conceição

Porto Alegre, Rio Grande do Sul, 91350-200, Brazil

Location

Fundação Pio XII - Hospital de Câncer de Barretos

Barretos, São Paulo, 14784-400, Brazil

Location

Universidade Federal de São Paulo - Hospital São Paulo

São Paulo, São Paulo, 04023-900, Brazil

Location

Hospital Israelita Albert Einstein

São Paulo, São Paulo, 05651-901, Brazil

Location

Related Links

MeSH Terms

Conditions

NeoplasmsPancreatic NeoplasmsNeoplasm Metastasis

Interventions

beta-D-glucosylisophosphoramide mustardGemcitabine

Condition Hierarchy (Ancestors)

Digestive System NeoplasmsNeoplasms by SiteEndocrine Gland NeoplasmsDigestive System DiseasesPancreatic DiseasesEndocrine System DiseasesNeoplastic ProcessesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Heterocyclic CompoundsDeoxycytidineCytidinePyrimidine NucleosidesPyrimidinesHeterocyclic Compounds, 1-Ring

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

February 1, 2005

First Posted

February 2, 2005

Study Start

December 1, 2004

Primary Completion

July 1, 2007

Study Completion

July 1, 2007

Last Updated

April 30, 2009

Record last verified: 2009-04

Locations

BR(6)US(3)