Cervical Adenocarcinoma Clinical Trial
Official title:
A Phase II Evaluation of ABT-888 (NCI Supplied Agent: ABT-888, NSC #737664), Topotecan (NSC # 609699) and Filgrastim or Pegfilgrastim in the Treatment of Persistent or Recurrent Squamous or Non-squamous Cell Carcinoma of the Cervix
This phase II clinical trial is studying the how well veliparib, topotecan hydrochloride, and filgrastim or pegfilgrastim work in treating patients with persistent or recurrent cervical cancer. Veliparib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as topotecan hydrochloride, work in different ways to stop the growth of tumor cells, either by killing the cells or by blocking them from dividing. Giving veliparib with chemotherapy may kill more tumor cells. Filgrastim or pegfilgrastim may cause the body to make more blood cells and help it recover from the side effects of chemotherapy.
PRIMARY OBJECTIVES:
I. To estimate the antitumor activity (objective response rate by RECIST 1.1) of ABT-888
(veliparib) 10 mg administered orally twice a day on days 1 to 5 with topotecan (topotecan
hydrochloride) 0.6 mg/m^2 administered IV once daily on days 1 to 5 of each cycle in patients
with persistent or recurrent carcinoma of the cervix.
II. To determine the nature and degree of toxicity of ABT-888 and topotecan in patients with
persistent or recurrent carcinoma of the cervix.
SECONDARY OBJECTIVES:
I. To determine the duration of progression-free survival and overall survival.
TERTIARY OBJECTIVES:
I. To determine whether evidence of an interaction exists between study treatments and tumor
expression of poly(ADP-ribos)ylation of E2 protein, E6/E7 proteins, and p53R2 in relation to
progression-free and overall survival or metastasis. (Translational) II. To explore the
association between methylation of FanCF and BRCA in pre-treatment tumor samples and pre- and
post-treatment biopsy samples and response, progression-free and overall survival of
patients, and/or metastasis. (Translational)
OUTLINE:
Patients receive veliparib orally (PO) twice daily and topotecan hydrochloride intravenously
(IV) over 30 minutes once daily on days 1-5. Patients also receive, according to
institutional standard, filgrastim subcutaneously (SC) beginning on day 6, 7, or 8 and
continuing until hematopoietic recovery or pegfilgrastim SC on day 6, 7, or 8. Courses repeat
every 21 days in the absence of disease progression or unacceptable toxicity.
Tumor tissue samples may be collected periodically for translational studies.
After completion of study treatment, patients are followed up every 3 months for 2 years and
then every 6 months for 3 years.
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