Study of Drug to Reduce Thrombocytopenia in Patients Receiving Chemo for Ovarian, Fallopian Tube or Peritoneal Cancer
Condition: Thrombocytopenia; Neutropenia; Lymphopenia; Anemia
MeSH terms: Thrombocytopenia; Neutropenia; Lymphopenia
Intervention: TXA127; TXA127; Placebo
Intervention description: Once daily subcutaneous injection of 100 ug/kg; Once daily subcutaneous injection of 300 ug/kg; Once daily subcutaneous injection of placebo
Intervention MeSH terms: Angiotensin I (1-7)
Phase: Phase 2
Study type: Interventional
Primary purpose: Supportive Care
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 34.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Ovarian Cancer; Thrombocytopenia; Cytopenia; Chemotherapy

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