A Study Comparing CO-1.01 With Gemcitabine as First Line Therapy in Patients With Metastatic Pancreatic Adenocarcinoma (LEAP)
Condition: Metastatic Pancreatic Adenocarcinoma
MeSH terms: Adenocarcinoma
Intervention: CO-1.01; Gemcitabine
Intervention description: 1250 mg/m2 intravenous infusion weekly for 3 weeks every 4 weeks; 1000 mg/m2 intravenous infusion weekly for 7 weeks followed by 1 week rest, then weekly for 3 weeks every 4 weeks
Intervention MeSH terms: Gemcitabine
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 367.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: cancer; metastatic; pancreatic; pancreas; adenocarcinoma; gemcitabine; human equilibrative nucleoside transporter-1 (hENT1); CO-1.01; CO-101; CO101; Stage 4; Stage IV

Summary:

      The purpose of this study is to determine whether CO-1.01 is safe and effective in the
      treatment of patients with metastatic pancreatic cancer and low hENT1 expression compared
      with gemcitabine.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Metastatic pancreatic ductal adenocarcinoma (i.e., Stage 4).

          -  Histological/cytological confirmation of metastatic tissue (not primary tumor) by a
             central pathology laboratory (H&E stain) to ensure sufficient material is available
             for later hENT1 analysis.

          -  Adjuvant chemotherapy/radiotherapy ≥ 6 months prior to randomization.

          -  Palliative radiotherapy (if administered) ≥ 1 month prior to randomization.

          -  CT scan ≤30 days prior to randomization

          -  Performance Status (ECOG) 0 or 1.

          -  Estimated life expectancy ≥ 12 weeks.

          -  Age ≥ 18 years.

          -  Adequate hematological and biological function.

          -  Written consent on an Institutional Review Board/Institutional Ethics
             Committee-approved Informed Consent Form prior to any study-specific evaluation.

        Exclusion Criteria:

          -  Prior palliative chemotherapy for pancreatic cancer.

          -  Radical pancreatic resections (e.g., Whipple procedure) are not allowed < 6 months
             prior to randomization. Exploratory laparotomy, palliative (e.g., bypass) surgery, or
             other procedures (e.g., stents) are not allowed < 14 days prior to randomization. In
             both cases the patient must be sufficiently recovered and stable.

          -  Symptomatic brain metastases.

          -  Participation in other investigational drug clinical studies ≤ 30 days prior to
             randomization.

          -  Concomitant treatment with prohibited medications.

          -  History of allergy to gemcitabine or eggs.

          -  Presence of any serious or unstable concomitant systemic disorder incompatible with
             the clinical study (e.g., substance abuse, uncontrolled intercurrent illness including
             active infection, arterial thrombosis, symptomatic pulmonary embolism).

          -  Any disorder that would hamper protocol compliance.

          -  Prior nonpancreatic malignancy treated with chemotherapy. Prior malignancies treated
             with surgery or radiotherapy alone must be in remission ≥ 3 years. The following prior
             malignancies are allowable irrespective of when they occurred: in situ carcinoma of
             the cervix, in situ ductal breast cancer, low-grade local bladder cancer, and
             nonmelanotic skin cancer.

          -  Females who are pregnant or breastfeeding.

          -  Refusal to use adequate contraception for fertile patients (females and males during
             the study and for 6 months after the last study treatment). Adequate forms of
             contraception are double-barrier methods (condoms or diaphragm with spermicidal jelly
             or foam); oral, depot, or injectable contraceptives; intrauterine devices; tubal
             ligation.

          -  Any other reason the investigator considers the patient should not participate in the
             study.