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

This study is currently recruiting participants.
Verified April 2013 by Spectrum Pharmaceuticals, Inc
Sponsor:
Information provided by (Responsible Party):
Spectrum Pharmaceuticals, Inc
ClinicalTrials.gov Identifier:
NCT01773785
First received: January 14, 2013
Last updated: April 23, 2013
Last verified: April 2013
History of Changes
  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:

MedlinePlus related topics: Cancer
Drug Information available for: Docetaxel
U.S. FDA Resources

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01773785

Contacts
Contact: Shanta Chawla, MD 949-743-6257 shanta.chawla@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     305-243-0864     k.mertz-rivera@med.miami.edu    
Principal Investigator: Caio Rocha Lima, MD            
Sponsors and Collaborators
Spectrum Pharmaceuticals, Inc
Investigators
Principal Investigator: Caio Rocha-Lima, MD University of Miami
  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: April 23, 2013
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 May 22, 2013