A Study Comparing CO-1.01 With Gemcitabine as First Line Therapy in Patients With Metastatic Pancreatic Adenocarcinoma (LEAP)

Completed · Phase 2

Conditions studied: Metastatic Pancreatic Adenocarcinoma

In brief

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.

Key facts

Study ID

NCT01124786

Run by

Clovis Oncology, Inc.

People needed

367

Starts

2010-05-01

Expected to finish

2013-06-01

Last updated by the study team

2014-04-17

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Wilshire Oncology Medical Group, Inc. — Corona, California, United States
• White Memorial Medical Center — Los Angeles, California, United States
• Cancer Care Institute — Los Angeles, California, United States
• Newport Cancer Care Medical — Newport Beach, California, United States
• Hematology Oncology Associates — Oakland, California, United States
• Sharp Clinical Oncology Research — San Diego, California, United States
• Rocky Mountain Cancer Centers — Denver, Colorado, United States
• Hartford Hospital Clinical Research — Hartford, Connecticut, United States
• Oncology Associates of Bridgeport — Trumbull, Connecticut, United States
• Annapolis Oncology Center — Annapolis, Maryland, United States
• Virginia Piper Cancer Institute — Minneapolis, Minnesota, United States
• The Cancer Institute of New Jersey — New Brunswick, New Jersey, United States
• New Mexico Cancer Care Alliance — Albuquerque, New Mexico, United States
• Arena Oncology Associates, PC — Lake Success, New York, United States
• Bend Memorial Clinic — Bend, Oregon, United States
• Cancer Center of the Carolinas — Greenville, South Carolina, United States
• Cancer Specialists of South Texas, P.A. — Corpus Christi, Texas, United States
• Valley Cancer Associates — Harlingen, Texas, United States
• South Texas Oncology and Hematology, PA — San Antonio, Texas, United States
• Medical College of Wisconsin — Milwaukee, Wisconsin, United States
• Policlínica Privada Instituto de Medicina Nuclear — Buenos Aires, Bahia Blanca, Argentina
• Instituto Especializado Alexander Fleming — Cuidad Autónoma de Buenos Aires, Buenos Aires, Argentina
• Hospital de Gastroenterología — Loma Hermosa, Buenos Aires, Argentina
• Clínica Universitaria Reina Fabiola — Córdoba, Córdoba Province, Argentina
• Arizona Center for Hematology Oncology — Glendale, Arizona, United States

Full record on ClinicalTrials.gov

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