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A Phase II Randomized, Open-Label, Multicenter Study Comparing CO-1.01 With Gemcitabine as First-Line Therapy in Patients With Metastatic Pancreatic Adenocarcinoma

Phase 2
18 Years
Open (Enrolling)
Metastatic Pancreatic Adenocarcinoma

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Trial Information

A Phase II Randomized, Open-Label, Multicenter Study Comparing CO-1.01 With Gemcitabine as First-Line Therapy in Patients With Metastatic Pancreatic Adenocarcinoma

Pancreatic cancer is a very serious form of cancer. The majority of patients present with
unresectable disease, and the condition is often not diagnosed until the cancer is
relatively advanced. The standard first-line treatment for patients with unresectable
pancreatic cancer is gemcitabine monotherapy. Unfortunately many of these patients fail to
derive benefit from this treatment. No clinical or molecular marker has been established to
predict benefit from gemcitabine therapy, so patients are treated empirically until evidence
of disease progression or worsening performance status.

The potential for human equilibrative nucleoside transporter-1 (hENT1) expression to predict
survival in gemcitabine-treated patients has been studied, and data suggest that patients
with low levels of tumor cell hENT1 expression derive less benefit from gemcitabine
treatment than patients with high levels of tumor cell hENT1 expression. These data support
the hypothesis to be tested in this study that patients with pancreatic tumors expressing
low levels of hENT1 will derive minimal benefit from gemcitabine, but will receive benefit
from CO-1.01 (gemcitabine elaidate) which enters tumor cells in a hENT1-independent fashion.

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 IRB/IEC-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

- 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

- Any other reason the investigator considers the patient should not participate in the

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Overall survival in patients with low hENT1 expression

Outcome Time Frame:

Monthly follow up after treatment discontinuation until death

Safety Issue:



United States: Food and Drug Administration

Study ID:




Start Date:

May 2010

Completion Date:

Related Keywords:

  • Metastatic Pancreatic Adenocarcinoma
  • cancer
  • metastatic
  • pancreatic
  • pancreas
  • adenocarcinoma
  • gemcitabine
  • human equilibrative nucleoside transporter-1 (hENT1)
  • CO-1.01
  • CO-101
  • CO101
  • Stage 4
  • Stage IV
  • Adenocarcinoma
  • Adenocarcinoma, Mucinous



Medical College of WisconsinMilwaukee, Wisconsin  53226
Virginia Piper Cancer InstituteMinneapolis, Minnesota  55407
Wilshire Oncology Medical Group, Inc.Rancho Cucamonga, California  91730
Rocky Mountain Cancer CentersThornton, Colorado  80260
Bend Memorial ClinicBend, Oregon  97701
Cancer Specialists of South Texas, P.A.Corpus Christi, Texas  78412
The Cancer Institute of New JerseyNew Brunswick, New Jersey  08901
Annapolis Oncology CenterAnnapolis, Maryland  21401
Sharp Clinical Oncology ResearchSan Diego, California  92123
Cancer Center of the CarolinasGreenville, South Carolina  29615
Oncology Associates of BridgeportTrumball, Connecticut  06611
New Mexico Cancer Care AllianceAlbuquerque, New Mexico  87106
South Texas Oncology and Hematology, PASan Antonio, Texas  78229
Arena Oncology Associates, PCGreat Neck, New York  11021
Hematology Oncology AssociatesOakland, California  94609
Cancer Care InstituteLos Angeles, California  90036
Arizona Center for Hematology OncologyGlendale, Arizona  85306
White Memorial Medical CenterLos Angeles, California  90033
Newport Cancer Care MedicalNewport Beach, California  92660
Hartford Hospital Clinical ResearchHartford, Connecticut  06102
Valley Cancer AssociatesHarlingen, Texas  78550