Clinical trial NCT00102752: Study of Safety and Efficacy of Glufosfamide in Combination With Gemcitabine in Cancer
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Neoplasms
Pancreatic Neoplasms
Keywords: Pancreas
Cancer
Metastatic
Glufosfamide
Advanced
Solid
Tumor
Advanced Solid Tumors
Pancreatic Adenocarcinoma
Lead sponsor: Threshold Pharmaceuticals
Sponsor class: INDUSTRY
Collaborators: name: PPD Development, LP
First posted: 2005-02-02
Enrollment: 47
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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

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 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

Primary outcomes:
measure: Overall objective response rate
Secondary outcomes:
measure: Overall survival
measure: 6- and 12- month survival
measure: Progression-free survival
measure: Duration of objective response
measure: Serum CA-19-9
Other outcomes:
Locations:
city: Tucson
country: United States
facility: Arizona Cancer Center
state: Arizona
city: Indianapolis
country: United States
facility: Indiana Cancer Center
state: Indiana
city: Louisville
country: United States
facility: Norton Healthcare Cancer Center
state: Kentucky
city: Nova Lima
country: Brazil
facility: Hospital de Doenças Cardiovasculares - Biocor
state: BH
city: Porto Alegre
country: Brazil
facility: Hospital Mãe de Deus
state: RS
city: Porto Alegre
country: Brazil
facility: Hospital Nossa Senhora da Conceição
state: RS
city: Barretos
country: Brazil
facility: Fundação Pio XII - Hospital de Câncer de Barretos
state: SP
city: São Paulo
country: Brazil
facility: Universidade Federal de São Paulo - Hospital São Paulo
state: SP
city: São Paulo
country: Brazil
facility: Hospital Israelita Albert Einstein
state: SP
Study officials:
References: