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Study of Drug to Reduce Thrombocytopenia in Patients Receiving Chemo for Ovarian, Fallopian Tube or Peritoneal Cancer

NCT ID: NCT00771810

Last Updated: 2017-11-13

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

34 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-10-31

Study Completion Date

2011-12-31

Brief Summary

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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.

Detailed Description

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This is a Phase IIb, multicenter, randomized, double-blind, placebo-controlled study comparing safety and efficacy of two dose levels of TXA127 when administered during 6 cycles of combination gemcitabine and platinum-based chemotherapy. This study intends to investigate the effectiveness of TXA127 for the mitigation of severity and/or incidence of thrombocytopenia, as well as safety when administered as a self-injected, subcutaneous solution.

Females 18 years of age or older with a confirmed diagnosis of ovarian carcinoma who are scheduled to undergo combination chemotherapy with gemcitabine and carboplatin or gemcitabine and cisplatin will be considered for this study. Subjects may be chemotherapy naïve, newly diagnosed, or post a single course of chemotherapy followed by a progression- and treatment-free interval of at least 3 months, or post 2 or more previous courses of chemotherapy after a progression- and treatment-free interval of at least 6 months.

Subjects will be randomized in a 1:1:1 ratio to one of the following three blinded treatment groups: placebo, 100 ug/kg/day TXA127 and 300 ug/kg/day TXA127.

Treatment will be concurrent with up to six consecutive 21-day cycles of one of the following gemcitabine and platin regimens:

Regimen A

* Intravenous cisplatin therapy at a dose of 30-50 mg/m2 given on Day 1 of the cycle
* Intravenous gemcitabine at a dose of 800 mg/m2 given on Day 1 after cisplatin and on Day 8 of the cycle.

Regimen B

* Intravenous gemcitabine at a dose of 1000 mg/m2 given on Days 1 and 8 of the cycle
* Intravenous carboplatin AUC 4 given after gemcitabine on Day 1 of the cycle

TXA127 will be self-administered as a subcutaneous injection by the subject once daily on Days 2-6 and 9-15 during each cycle of chemotherapy. Blood specimens will be drawn for hematologic analysis on Days 1, 8 and 15 of each treatment cycle.

Conditions

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Thrombocytopenia Neutropenia Lymphopenia Anemia

Keywords

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Ovarian Cancer Thrombocytopenia Cytopenia Chemotherapy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Placebo

Combination gemcitabine and platinum-based chemotherapy with concurrent placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Once daily subcutaneous injection of placebo

TXA127 100 ug/kg

Combination gemcitabine and platinum-based chemotherapy with concurrent 100 ug/kg/day TXA127

Group Type EXPERIMENTAL

TXA127

Intervention Type DRUG

Once daily subcutaneous injection of 100 ug/kg

TXA127 300 ug/kg

Combination gemcitabine and platinum-based chemotherapy with concurrent 300 ug/kg/day TXA127

Group Type EXPERIMENTAL

TXA127

Intervention Type DRUG

Once daily subcutaneous injection of 300 ug/kg

Interventions

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TXA127

Once daily subcutaneous injection of 100 ug/kg

Intervention Type DRUG

TXA127

Once daily subcutaneous injection of 300 ug/kg

Intervention Type DRUG

Placebo

Once daily subcutaneous injection of placebo

Intervention Type DRUG

Other Intervention Names

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Angiotensin 1-7 Angiotensin 1-7

Eligibility Criteria

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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

* 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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Tarix Pharmaceuticals

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Gere S diZerega, MD

Role: STUDY_DIRECTOR

US Biotest, Inc.

Locations

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University of Southern Alabama Mitchell Cancer Institute

Mobile, Alabama, United States

Site Status

USC - LAC Medical Center

Los Angeles, California, United States

Site Status

University of California - Irvine, Chao Family Comprehensive Cancer Center

Orange, California, United States

Site Status

Rush University Medical Center

Chicago, Illinois, United States

Site Status

Associates in Women's Health

Wichita, Kansas, United States

Site Status

Schwartz Gynecologic Oncology, PLLC

Brightwaters, New York, United States

Site Status

Countries

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United States

References

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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.

Reference Type BACKGROUND
PMID: 16096787 (View on PubMed)

Ellefson 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.

Reference Type BACKGROUND
PMID: 14569417 (View on PubMed)

Other Identifiers

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TXA127-2007-002

Identifier Type: -

Identifier Source: org_study_id