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

Primary Purpose

Biliary Cancer

Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
SPI-1620
Docetaxel
Sponsored by
Spectrum Pharmaceuticals, Inc
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Biliary Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Miami Hospitals & Clinics/ Sylvester Comprehensive Cancer Center
  • H. Lee Moffitt Cancer Center
  • Washington University School of Medicine
  • Associates in Oncology and Hematology
  • The West Clinic
  • Seattle Cancer Care Alliance

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

SPI-1620 & Docetaxel

Arm Description

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.

Outcomes

Primary Outcome Measures

Progression free survival

Secondary Outcome Measures

Overall response rate
Overall survival
Duration of Response
Safety of SPI-1620 when administered in combination with docetaxel
Periodic physical examinations with vital sign monitoring, safety laboratories and monitoring of adverse events will be performed

Full Information

First Posted
January 14, 2013
Last Updated
October 8, 2021
Sponsor
Spectrum Pharmaceuticals, Inc
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1. Study Identification

Unique Protocol Identification Number
NCT01773785
Brief Title
Phase II Study of SPI-1620 in Combination With Docetaxel as a Second-Line to Treat Biliary Cancer
Official Title
Phase II Study of SPI-1620 in Combination With Docetaxel as a Second-Line Treatment for Patients With Advanced Biliary Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
October 2021
Overall Recruitment Status
Terminated
Why Stopped
The study completed the first phase and did not meet efficacy end point to enter into the randomized phase.
Study Start Date
April 2013 (Actual)
Primary Completion Date
September 2015 (Actual)
Study Completion Date
September 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Spectrum Pharmaceuticals, Inc

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Biliary Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
SPI-1620 & Docetaxel
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
SPI-1620
Intervention Description
SPI-1620 11 μg/m2 will be given intravenously over 1 minute.
Intervention Type
Drug
Intervention Name(s)
Docetaxel
Intervention Description
Docetaxel 75 mg/m2 infusion will be administered per standard of care 10 (±2) minutes after SPI-1620.
Primary Outcome Measure Information:
Title
Progression free survival
Time Frame
18 months
Secondary Outcome Measure Information:
Title
Overall response rate
Time Frame
18 months
Title
Overall survival
Time Frame
18 months
Title
Duration of Response
Time Frame
12 months
Title
Safety of SPI-1620 when administered in combination with docetaxel
Description
Periodic physical examinations with vital sign monitoring, safety laboratories and monitoring of adverse events will be performed
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
University of Miami Hospitals & Clinics/ Sylvester Comprehensive Cancer Center
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Facility Name
H. Lee Moffitt Cancer Center
City
Tampa
State/Province
Florida
ZIP/Postal Code
33612
Country
United States
Facility Name
Washington University School of Medicine
City
Saint Louis
State/Province
Missouri
Country
United States
Facility Name
Associates in Oncology and Hematology
City
Chattanooga
State/Province
Tennessee
ZIP/Postal Code
37421
Country
United States
Facility Name
The West Clinic
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38120
Country
United States
Facility Name
Seattle Cancer Care Alliance
City
Seattle
State/Province
Washington
ZIP/Postal Code
98109
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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