Phase II Trial Of Gemcitabine Plus Nab-Paclitaxel +/- OGX-427 In Patients With Metastatic Pancreatic Cancer (Rainier)

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2013 by SCRI Development Innovations, LLC
Sponsor:
Collaborator:
OncoGenex Pharmaceuticals
Information provided by (Responsible Party):
SCRI Development Innovations, LLC
ClinicalTrials.gov Identifier:
NCT01844817
First received: April 29, 2013
Last updated: April 22, 2014
Last verified: November 2013
  Purpose

To compare the overall survival in patients with previously untreated metastatic pancreatic cancer receiving:

gemcitabine/nab-paclitaxel plus OGX-427 or gemcitabine/nab-paclitaxel plus placebo


Condition Intervention Phase
Pancreatic Cancer
Drug: OGX-427
Drug: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized, Double-Blinded, Placebo-Controlled Phase II Trial Of Gemcitabine Plus Nab-Paclitaxel Combined With OGX-427 Or Placebo In Patients With Metastatic Pancreatic Cancer (The Rainier Trial)

Resource links provided by NLM:


Further study details as provided by SCRI Development Innovations, LLC:

Primary Outcome Measures:
  • Overall Survival [ Time Frame: Time from randomization until death ] [ Designated as safety issue: No ]
    To compare the overall survival in patients with previously untreated metastatic pancreatic cancer receiving gemcitabine/nab-paclitaxel plus OGX-427 versus gemcitabine/nab-paclitaxel plus placebo)


Secondary Outcome Measures:
  • Progression-Free Survival [ Time Frame: Every 8 weeks ] [ Designated as safety issue: No ]
    To compare progression-free survival in each arm

  • Objective Response Rate [ Time Frame: Every 8 weeks ] [ Designated as safety issue: No ]
    To compare objective response rate for each treatment arm

  • CA19-9 Levels [ Time Frame: Every cycle (4 weeks) ] [ Designated as safety issue: No ]
    To compare CA19-9 levels between treatment arms of patients with elevated levels at baseline

  • Safety of the regimen [ Time Frame: Continuous review ] [ Designated as safety issue: Yes ]
    To compare the safety/tolerability of gemcitabine/nab-paclitaxel/placebo with gemcitabine/nab-paclitaxel/OGX-427. Toxicities will be assessed using Common Terminology Criteria for Adverse Events v4.0


Other Outcome Measures:
  • Serum Levels of Hsp27 [ Time Frame: Every cycle (4 weeks) ] [ Designated as safety issue: No ]
    To evaluate the effect of treatment with OGX-427 on serum HSP-27 levels


Estimated Enrollment: 132
Study Start Date: August 2013
Estimated Study Completion Date: May 2016
Estimated Primary Completion Date: February 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: OGX-427
Three loading doses of OGX-427 at 600mg IV will be administered Days -9 to -1. Following the loading dose period, OGX-427 will be administered at 600mg IV weekly Days 1, 8, 15, and 22 of each 28 day cycle during the Treatment Phase.
Drug: OGX-427
Three separate administrations of OGX-427 will be given during the 9-day Loading Dose Period. Following the Loading Dose Period, patients will receive 600mg OGX-427 prior to the administration of nab-paclitaxel (125mg/m2 IV)and gemcitabine (1000mg/m2 IV)administration on Day 1, 8, and 15 of each cycle. OGX-427 will also be administered on Day 22 during each cycle (i.e., weekly). Patients will continue 28 day treatment cycles until disease progression or until other reasons for discontinuation from treatment.
Placebo Comparator: Placebo
Three loading doses of placebo will be administered Days -9 to -1. Following the loading dose period, placebo will be administered weekly Days 1, 8, 15, and 22 of each 28 day cycle.
Drug: Placebo
Three separate administrations of Placebo will be given during the 9-day Loading Dose Period. Following the Loading Dose Period, patients will receive placebo prior to the administration of nab-paclitaxel (125mg/m2 IV)and gemcitabine (1000mg/m2 IV)administration on Day 1, 8, and 15 of each cycle. Placebo will also be administered on Day 22 during each cycle (i.e., weekly). Patients will continue 28 day treatment cycles until disease progression or until other reasons for discontinuation from treatment.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Histologically- or cytologically confirmed pancreatic adenocarcinoma
  2. Stage IV disease (measurable disease NOT required)
  3. Eastern Cooperative Oncology Group (ECOG) performance score of 0-1
  4. At least 18 years of age
  5. Female patients who are not of child-bearing potential, and fertile female patients of child-bearing potential who agree to use adequate contraceptive measures, who are not breastfeeding, and who have a negative serum or urine pregnancy test within 72 hours prior to start of randomization.
  6. Fertile male patients willing to use adequate contraceptive measures.
  7. Adequate bone marrow function:

    • Absolute neutrophil count (ANC) ≥ 1500/uL
    • platelet count ≥ 100,000/uL
    • hemoglobin ≥ 9.0 g/dL
  8. Adequate hepatic function:

    • Total bilirubin ≤ 1.5 X ULN
    • Aspartate amino transferase (AST) (SGOT) ≤ 3.0 X ULN
    • Alanine aminotransferase (ALT) (SGPT) ≤ 3.0 X ULN
  9. Adequate renal function (defined as serum creatinine ≤ 1.5 X ULN)
  10. Ability to understand the nature of this study protocol, comply with study and/or follow-up procedures, and give written informed consent
  11. Willingness and ability to comply with scheduled visits, treatment plans, laboratory tests, and other study procedures.

Exclusion Criteria:

  1. Any prior systemic or investigational therapy for metastatic pancreatic cancer. Systemic therapy administered alone or in combination with radiation in the adjuvant or neoadjuvant setting is permissible as long as it was completed > 6 months prior to the time of study randomization.
  2. History of other diseases, metabolic dysfunction, physical examination findings, or clinical laboratory findings giving reasonable suspicion of a disease or condition that, in the opinion of the investigator, renders the subject at high risk from treatment complications or might affect the interpretation of the results of the study.
  3. Presence of known central nervous system or brain metastases.
  4. Known human immunodeficiency virus (HIV) infection.
  5. Active second invasive malignancy (except non-melanomatous skin cancer), defined as any malignancy with current need for cancer therapy or high possibility (>30%) of recurrence during the study.
  6. Patients receiving warfarin. However, therapeutic anticoagulation with Low Molecular Weight Heparin (LMWH)is allowed.
  7. Clinically significant cardiac disease (e.g. congestive heart failure, symptomatic coronary artery disease, and cardiac arrhythmias not well controlled with medication) or myocardial infarction within the last 6 months.
  8. Current sensory neuropathy > Grade 1.
  9. Major surgery within 4 weeks of the start of study treatment (defined as those surgeries that require general anesthesia. Insertion of a vascular access device is NOT considered major surgery.). Patients must have recovered from the side effects of any major surgery prior to randomization.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01844817

Contacts
Contact: Sarah Cannon Research Institute (SCRI) 877-691-7274 asksarah@scresearch.net

Locations
United States, California
University of California-San Francisco Recruiting
San Francisco, California, United States, 94115
United States, Florida
Florida Cancer Specialists-South Recruiting
Ft. Myers, Florida, United States, 33916
Florida Hospital Cancer Insitute Recruiting
Orlando, Florida, United States, 32804
Florida Cancer Specialists-North Recruiting
St. Petersburg, Florida, United States, 33705
United States, Illinois
Ingalls Cancer Research Center Recruiting
Harvey, Illinois, United States, 60426
United States, Ohio
Oncology Hematology Care, Inc. Recruiting
Cincinnati, Ohio, United States, 45242
United States, South Carolina
South Carolina Oncology Associates Recruiting
Columbia, South Carolina, United States, 29210
United States, Tennessee
Tennessee Oncology - Chattanooga Recruiting
Chattanooga, Tennessee, United States, 37404
Tennessee Oncology, PLLC Recruiting
Nashville, Tennessee, United States, 37203
Contact: AskSARAH       AskSARAH@scresearch.net   
United States, Texas
The Center for Cancer and Blood Disorders Recruiting
Fort Worth, Texas, United States, 76104
United States, Virginia
Virginia Cancer Institute Recruiting
Richmond, Virginia, United States, 23230
Sponsors and Collaborators
SCRI Development Innovations, LLC
OncoGenex Pharmaceuticals
Investigators
Study Chair: Johanna Bendell, M.D. SCRI
  More Information

No publications provided

Responsible Party: SCRI Development Innovations, LLC
ClinicalTrials.gov Identifier: NCT01844817     History of Changes
Other Study ID Numbers: SCRI GI 184
Study First Received: April 29, 2013
Last Updated: April 22, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by SCRI Development Innovations, LLC:
untreated
metastatic
OGX-427

Additional relevant MeSH terms:
Pancreatic Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases
Gemcitabine
Paclitaxel
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Radiation-Sensitizing Agents
Antineoplastic Agents, Phytogenic
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators

ClinicalTrials.gov processed this record on August 19, 2014