Phase 2
N=34
Study of Drug to Reduce Thrombocytopenia in Patients Receiving Chemo for Ovarian, Fallopian Tube or Peritoneal Cancer
Thrombocytopenia · Neutropenia · Lymphopenia · Anemia
Bottom Line
View on ClinicalTrials.gov: NCT00771810 ↗Enrolled (actual)
34
Serious AEs
20.6%
Results posted
Jun 2013
Primary outcome: Primary: Chemotherapy Cycles During Which the Platelet Count Measures Below 50,000/mm3 — 20.0; 11.7; 21.5 Percentage of cycles
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- TXA127 (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- Tarix Pharmaceuticals
- Primary completion
- Dec 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Chemotherapy Cycles During Which the Platelet Count Measures Below 50,000/mm3 |
20.0; 11.7; 21.5 | — |
| SECONDARY Subjects With Platelet Counts Below 50,000/mm3 |
5; 4; 6 | — |
| SECONDARY Treatment Cycles With Platelets Counts Below 25,000/mm3 |
5.8; 0; 10.4 | — |
| SECONDARY Chemotherapy Dose Intensity and Dose Density |
67.6; 86.5; 71.7; 76.7; 88.7; 79.5 | — |
| SECONDARY Lymphopenia as Determined by Lymphocyte Count |
1; 0; 0 | — |
| SECONDARY Neutropenia |
7; 5; 8 | — |
| SECONDARY Anemia |
2; 4; 5 | — |
| SECONDARY Mucositis |
2; 0; 1 | — |
| SECONDARY Alopecia |
1; 2; 3 | — |
| SECONDARY Rescue Treatment for Hematopoiesis and Mucositis |
2; 4; 2; 4; 2; 5 | — |
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.
Eligibility Criteria
Inclusion Criteria
- 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
Exclusion Criteria
- Any clinical or laboratory abnormality greater than Grade 2 toxicity (NCI criteria), with the exception of laboratory parameters specified in the inclusion criteria
- 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)
- Radiation therapy or chemotherapy (except as specified in the inclusion criteria) within the previous 5 years
- Concurrent use of hematopoietic or erythropoietic agents
Data sourced from ClinicalTrials.gov (NCT00771810). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.