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

Phase 2

Terminated

• Conditions: Biliary Cancer
• Interventions: Drug: SPI-1620; Drug: Docetaxel

• Registration Number: NCT01773785
• Lead Sponsor: Spectrum Pharmaceuticals, Inc

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-01-14
• Study First Submitted QC: 2013-01-18
• Study First Posted: 2013-01-23
• Study Start: 2013-04
• Primary Completion: 2015-09
• Study Completion: 2015-09
• Disposition First Submitted: 2021-09-30
• Disposition First Submitted QC: 2021-09-30
• Status Verified: 2021-10
• Disposition First Posted: 2021-10-05
• Last Update Submitted: 2021-10-08
• Last Update Posted: 2021-10-13

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
SPI-1620 & Docetaxel	SPI-1620	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.
SPI-1620 & Docetaxel	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.

Primary Outcome Measures

Name	Time	Method
Progression free survival	18 months

Secondary Outcome Measures

Name	Time	Method
Overall response rate	18 months
Overall survival	18 months
Duration of Response	12 months
Safety of SPI-1620 when administered in combination with docetaxel	12 months	Periodic physical examinations with vital sign monitoring, safety laboratories and monitoring of adverse events will be performed

Trial Locations

Locations (6)

University of Miami Hospitals & Clinics/ Sylvester Comprehensive Cancer Center; 🇺🇸 Miami, Florida, United States

H. Lee Moffitt Cancer Center; 🇺🇸 Tampa, Florida, United States

Washington University School of Medicine; 🇺🇸 Saint Louis, Missouri, United States

Associates in Oncology and Hematology; 🇺🇸 Chattanooga, Tennessee, United States

The West Clinic; 🇺🇸 Memphis, Tennessee, United States

Seattle Cancer Care Alliance; 🇺🇸 Seattle, Washington, United States