Study of Drug to Reduce Thrombocytopenia in Patients Receiving Chemo for Ovarian, Fallopian Tube or Peritoneal Cancer
Ph IIb Study Evaluating the Safety & Efficacy of TXA127 in the Reduction of Incidence and Severity of Thrombocytopenia in Patients Receiving Combination Gemcitabine and Platinum Therapy for Ovarian, Fallopian Tube, or Peritoneal Carcinoma
1 other identifier
interventional
34
1 country
6
Brief Summary
This research study will investigate the safety and effectiveness of two different dose levels of a new, unapproved drug to be given along with the chemotherapy regimens gemcitabine and carboplatin or gemcitabine and cisplatin prescribed to women for the treatment of ovarian cancer. This experimental drug is called TXA127 and is being tested for effectiveness to see if it will help reduce some of the side effects of the chemotherapy, primarily low blood platelet levels that lead to excess bleeding. This study also intends to test the safety of TXA127 when given as an injection under the skin on a daily basis concurrently with up to 6 cycles of the prescribed chemotherapy.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started Oct 2008
Typical duration for phase_2
6 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2008
CompletedFirst Submitted
Initial submission to the registry
October 9, 2008
CompletedFirst Posted
Study publicly available on registry
October 13, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2011
CompletedResults Posted
Study results publicly available
June 7, 2013
CompletedNovember 13, 2017
October 1, 2017
3.2 years
October 9, 2008
February 25, 2013
October 10, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Chemotherapy Cycles During Which the Platelet Count Measures Below 50,000/mm3
Mean percentage of cycles with platelet counts below 50,000/mm3
During a maximum of six 3-week chemotherapy cycles
Secondary Outcomes (9)
Subjects With Platelet Counts Below 50,000/mm3
During a maximum of six 3-week chemotherapy cycles
Treatment Cycles With Platelets Counts Below 25,000/mm3
During a maximum of six 3-week chemotherapy cycles
Chemotherapy Dose Intensity and Dose Density
During a maximum of six 3-week chemotherapy cycles
Lymphopenia as Determined by Lymphocyte Count
During a maximum of six 3-week chemotherapy cycles
Neutropenia
During a maximum of six 3-week chemotherapy cycles
- +4 more secondary outcomes
Study Arms (3)
Placebo
PLACEBO COMPARATORCombination gemcitabine and platinum-based chemotherapy with concurrent placebo
TXA127 100 ug/kg
EXPERIMENTALCombination gemcitabine and platinum-based chemotherapy with concurrent 100 ug/kg/day TXA127
TXA127 300 ug/kg
EXPERIMENTALCombination gemcitabine and platinum-based chemotherapy with concurrent 300 ug/kg/day TXA127
Interventions
Eligibility Criteria
You may qualify if:
- Females at least 18 years of age with ovarian carcinoma who are one of the following:
- Newly diagnosed with ovarian cancer and chemotherapy naïve, or
- Post a single previous course of chemotherapy, with a 3-month disease-progression and treatment-free interval, with the exception of antibody therapy, prior to the study screening visit, or
- Post two or more previous courses of chemotherapy with a 6-month disease-progression and treatment-free interval, with the exception of antibody therapy, prior to the study screening visit.
- Must be scheduled for a course of combination chemotherapy consisting of gemcitabine and cisplatin or gemcitabine and carboplatin to be administered in 21-day cycles
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0, 1, or 2
- Adequate bone marrow, renal, and hepatic functions as measured by standard chemistry and hematology blood tests
- Adequate blood coagulation parameters as measured by standard blood tests for coagulation
You may not qualify if:
- Significant unstable cardiovascular disease
- Uncontrolled high blood pressure
- Current use of an angiotensin converting enzyme (ACE) inhibitor or angiotensin II antagonists
- Evidence of metastatic disease to the bone
- Metastatic disease to the CNS requiring treatment or radiation therapy
- Uncontrolled infection(s)
- Concurrent use of hematopoietic or erythropoietic agents
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (6)
University of Southern Alabama Mitchell Cancer Institute
Mobile, Alabama, 36604, United States
USC - LAC Medical Center
Los Angeles, California, 90033, United States
University of California - Irvine, Chao Family Comprehensive Cancer Center
Orange, California, 92868, United States
Rush University Medical Center
Chicago, Illinois, 60612, United States
Associates in Women's Health
Wichita, Kansas, 67208, United States
Schwartz Gynecologic Oncology, PLLC
Brightwaters, New York, 11718, United States
Related Publications (2)
Rodgers KE, Oliver J, diZerega GS. Phase I/II dose escalation study of angiotensin 1-7 [A(1-7)] administered before and after chemotherapy in patients with newly diagnosed breast cancer. Cancer Chemother Pharmacol. 2006 May;57(5):559-68. doi: 10.1007/s00280-005-0078-4. Epub 2005 Aug 12.
PMID: 16096787BACKGROUNDEllefson DD, diZerega GS, Espinoza T, Roda N, Maldonado S, Rodgers KE. Synergistic effects of co-administration of angiotensin 1-7 and Neupogen on hematopoietic recovery in mice. Cancer Chemother Pharmacol. 2004 Jan;53(1):15-24. doi: 10.1007/s00280-003-0710-0. Epub 2003 Oct 16.
PMID: 14569417BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Limitations and Caveats
Feasibility considerations (e.g., slow patient enrollment and lower incidence of Grade 3-4 thrombocytopenia than planned) necessitated early termination of the study after 34 patients had been enrolled.
Results Point of Contact
- Title
- Elizabeth Wagner
- Organization
- Tarix Pharmaceuticals
Study Officials
- STUDY DIRECTOR
Gere S diZerega, MD
US Biotest, Inc.
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- GT60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 9, 2008
First Posted
October 13, 2008
Study Start
October 1, 2008
Primary Completion
December 1, 2011
Study Completion
December 1, 2011
Last Updated
November 13, 2017
Results First Posted
June 7, 2013
Record last verified: 2017-10