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

Condition	Treatment or Intervention	Phase
Neoplasms Pancreatic Neoplasms	Drug: Glufosfamide  Drug: Gemcitabine	Phase I Phase II

Further Study Details: 

Primary Outcomes: Overall objective response rate
Secondary Outcomes: Overall survival; 6- and 12- month survival; Progression-free survival; Duration of objective response; Serum CA-19-9
Expected Total Enrollment:  47

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.

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both

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

Arizona
      Arizona Cancer Center, Tucson,  Arizona,  85724,  United States; Not yet recruiting
Indiana
      Indiana Cancer Center, Indianapolis,  Indiana,  46202,  United States; Recruiting
Kentucky
      Norton Healthcare Cancer Center, Louisville,  Kentucky,  40202,  United States; Not yet recruiting
Brazil, BH
      Hospital de Doenças Cardiovasculares - Biocor, Nova Lima,  BH,  34000-000,  Brazil; Not yet recruiting
Brazil, RS
      Hospital Nossa Senhora da Conceição, Porto Alegre,  RS,  91350-200,  Brazil; Not yet recruiting
      Hospital Mãe de Deus, Porto Alegre,  RS,  90880-480,  Brazil; Not yet recruiting
Brazil, SP
      Fundação Pio XII - Hospital de Câncer de Barretos, Barretos,  SP,  14784-400,  Brazil; Not yet recruiting
      Universidade Federal de São Paulo - Hospital São Paulo, São Paulo,  SP,  04023-900,  Brazil; Not yet recruiting
      Hospital Israelita Albert Einstein, São Paulo,  SP,  05651-901,  Brazil; Not yet recruiting

Study ID Numbers:  TH-CR-301
Record last reviewed:  July 2004
Last Updated:  February 2, 2005
Record first received:  February 1, 2005
ClinicalTrials.gov Identifier:  NCT00102752
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-04-08