study of safety and efficacy of glufosfamide in combination with gemcitabine in cancer

Conditions: Neoplasms; Pancreatic Neoplasms

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

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

Keywords: pancreas cancer metastatic glufosfamide advanced solid tumor advanced solid tumors pancreatic adenocarcinoma