Phase II Study of SPI-1620 in Combination With Docetaxel as a Second-Line to Treat Biliary Cancer

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2014 by Spectrum Pharmaceuticals, Inc
Sponsor:
Information provided by (Responsible Party):
Spectrum Pharmaceuticals, Inc
ClinicalTrials.gov Identifier:
NCT01773785
First received: January 14, 2013
Last updated: June 10, 2014
Last verified: June 2014
  Purpose

The primary purpose of this study is to determine the effectiveness of SPI-1620 in combination with docetaxel in patients with advanced biliary cancer.


Condition Intervention Phase
Biliary Cancer
Drug: SPI-1620 & Docetaxel
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase II Study of SPI-1620 in Combination With Docetaxel as a Second-Line Treatment for Patients With Advanced Biliary Cancer

Resource links provided by NLM:


Further study details as provided by Spectrum Pharmaceuticals, Inc:

Primary Outcome Measures:
  • Progression free survival [ Time Frame: 18 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Overall response rate [ Time Frame: 18 months ] [ Designated as safety issue: No ]
  • Overall survival [ Time Frame: 18 months ] [ Designated as safety issue: No ]
  • Duration of Response [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Safety of SPI-1620 when administered in combination with docetaxel [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
    Periodic physical examinations with vital sign monitoring, safety laboratories and monitoring of adverse events will be performed


Estimated Enrollment: 39
Study Start Date: April 2013
Estimated Study Completion Date: July 2015
Estimated Primary Completion Date: July 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: SPI-1620 & Docetaxel
  • SPI-1620 11 μg/m2 will be given intravenously over 1 minute.
  • Docetaxel 75 mg/m2 infusion will be administered per standard of care 10 (±2) minutes after SPI-1620.
Drug: SPI-1620 & Docetaxel
Patients will receive 11 μg/m2 of SPI-1620 intravenously over one minute. Ten minutes after (±2 min) SPI-1620 administration, patients will receive docetaxel 75 mg/m2 intravenous. This regimen will be repeated every 3-weeks cycles until progression or intolerable toxicity.

  Eligibility

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

Inclusion Criteria:

  • Histologically confirmed biliary tract or gallbladder cancer that have relapsed or are refractory after one prior gemcitabine-based chemotherapy regimen for advanced biliary cancer
  • Evaluable disease
  • ECOG PS ≤ 2
  • Adequate bone marrow, liver and renal function

Exclusion Criteria:

  • Treatment with more than one prior chemotherapy regimen
  • Known, uncontrolled CNS metastases
  • Baseline peripheral neuropathy ≥ grade 2.
  • Significant circulatory disorders in the past 6 months
  • Concomitant use of phosphodiesterase inhibitors
  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: NCT01773785

Contacts
Contact: Angie Schinkel 949-743-9257 angie.schinkel@sppirx.com

Locations
United States, Florida
University of Miami Hospitals & Clinics/ Sylvester Comprehensive Cancer Center Recruiting
Miami, Florida, United States, 33136
Contact: Kamara Mertz-Rivera         
Principal Investigator: Caio Rocha Lima, MD         
H. Lee Moffitt Cancer Center Recruiting
Tampa, Florida, United States, 33612
Contact: Richard Kim, MD         
Principal Investigator: Richard Kim, MD         
United States, Missouri
Washington University School of Medicine Recruiting
St. Louis, Missouri, United States
Contact: Melissa Haley         
Principal Investigator: Manik Amin, MD         
United States, Tennessee
Associates in Oncology and Hematology Recruiting
Chattanooga, Tennessee, United States, 37421
Contact: Jitendra Gandhi, MD         
Principal Investigator: Jitendra Gandhi, MD         
The West Clinic Recruiting
Memphis, Tennessee, United States, 38120
Contact: Cindy Inman         
Principal Investigator: David Portnoy, MD         
United States, Washington
Seattle Cancer Care Alliance Recruiting
Seattle, Washington, United States, 98109
Contact: Lisa White         
Principal Investigator: Elena Chiorean, MD         
Sponsors and Collaborators
Spectrum Pharmaceuticals, Inc
Investigators
Study Director: Mi Rim Choi, MD Spectrum Pharmaceuticals, Inc
  More Information

No publications provided

Responsible Party: Spectrum Pharmaceuticals, Inc
ClinicalTrials.gov Identifier: NCT01773785     History of Changes
Other Study ID Numbers: SPI-1620-12-202
Study First Received: January 14, 2013
Last Updated: June 10, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Biliary Tract Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Biliary Tract Diseases
Digestive System Diseases
Docetaxel
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 23, 2014