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

• Sponsor: Spectrum Pharmaceuticals, Inc (Industry)
• Overall Status: Terminated
• CT.gov ID: NCT01773785
• Collaborator: (none)
• Enrollment: 30
• Locations: 6
• Arm: 1
• Actual Duration (Months): 29
• Patients Per Site: 5
• Patients Per Site Per Month: 0.2

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Biliary Cancer	Drug: SPI-1620; Drug: Docetaxel	Phase 2

Study Design

• Study Type: Interventional
• Actual Enrollment: 30 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (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
• Actual Study Start Date: Apr 1, 2013
• Actual Primary Completion Date: Sep 1, 2015
• Actual Study Completion Date: Sep 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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.	Drug: SPI-1620; SPI-1620 11 μg/m2 will be given intravenously over 1 minute.; Drug: Docetaxel; Docetaxel 75 mg/m2 infusion will be administered per standard of care 10 (±2) minutes after SPI-1620.

Outcome Measures

Primary Outcome Measures

1. Progression free survival [18 months]

Secondary Outcome Measures

1. Overall response rate [18 months]

2. Overall survival [18 months]

3. Duration of Response [12 months]

4. 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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1	University of Miami Hospitals & Clinics/ Sylvester Comprehensive Cancer Center	Miami	Florida	United States	33136
2	H. Lee Moffitt Cancer Center	Tampa	Florida	United States	33612
3	Washington University School of Medicine	Saint Louis	Missouri	United States
4	Associates in Oncology and Hematology	Chattanooga	Tennessee	United States	37421
5	The West Clinic	Memphis	Tennessee	United States	38120
6	Seattle Cancer Care Alliance	Seattle	Washington	United States	98109

Sponsors and Collaborators

• Spectrum Pharmaceuticals, Inc

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Spectrum Pharmaceuticals, Inc
• ClinicalTrials.gov Identifier: NCT01773785
• Other Study ID Numbers: SPI-1620-12-202
• First Posted: Jan 23, 2013
• Last Update Posted: Oct 13, 2021
• Last Verified: Oct 1, 2021

• Additional relevant MeSH terms: Biliary Tract Neoplasms; Docetaxel

Study Results

No Results Posted as of Oct 13, 2021