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The purpose of this study is to determine the maximum tolerated dose (MTD) of topotecan when given weekly with cisplatin in patients with persistent, recurrent, or advanced stage cervical cancer. Secondary purposes are to describe the toxicity profile in patients with persistent, recurrent, or advanced stage cervical cancer treated with the combination of topotecan when given weekly with cisplatin and to determine the response rate and time to progression in patients with persistent, recurrent, or advanced stage cervical cancer treated with the combination of topotecan when given weekly with cisplatin.
Patients diagnosed with recurrent cervical cancer generally have limited options for cure. Occasionally, radiation therapy may be utilized in localized recurrent disease with curative intent; however, most patients are not candidates for curative therapy secondary to disseminated disease, and thus are frequently treated with palliative chemotherapy. Initial experiences with chemotherapy in this clinical setting demonstrated cisplatin to be an active agent. Subsequent trials using combinations of cisplatin and ifosfamide or paclitaxel demonstrated higher response rates compared to cisplatin alone but did not demonstrate an improvement in overall survival. Topotecan is a topoisomerase I inhibitor that has been used in the management of cervical and ovarian cancer. Several phase II studies have demonstrated topotecan to be an active agent in cervical cancer. In an effort to ameliorate toxicity noted with 3-5 day dosing regimens of topotecan, investigators have evaluated weekly dosing of topotecan. Thus far, the toxicity of weekly topotecan dosing in cervical cancer has not been evaluated. In this study, topotecan will be given weekly at escalating dose levels starting at 2.0 mb/m2 with standard cisplatin at 50 mg/m2 every 21 days. This study will help to determine acceptable dosing for the combination of weekly topotecan and cisplatin in patients with persistent, recurrent, or advanced stage cervical cancer which can then be utilized in a cohort of patients with cervical cancer in a phase II study.
Allocation: Non-Randomized, Control: Uncontrolled, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
University of Alabama at Birmingham
University of Alabama at Birmingham
Published on BioPortfolio: 2014-08-27T03:44:50-0400
This study will be conducted in two parts. Part 1 will determine whether administration of MK1775 in combination with topotecan and cisplatin is generally well-tolerated and causes clinica...
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An antineoplastic agent used to treat ovarian cancer. It works by inhibiting DNA TOPOISOMERASES, TYPE I.
An inorganic and water-soluble platinum complex. After undergoing hydrolysis, it reacts with DNA to produce both intra and interstrand crosslinks. These crosslinks appear to impair replication and transcription of DNA. The cytotoxicity of cisplatin correlates with cellular arrest in the G2 phase of the cell cycle.
Tumors or cancer of the COLON or the RECTUM or both. Risk factors for colorectal cancer include chronic ULCERATIVE COLITIS; FAMILIAL POLYPOSIS COLI; exposure to ASBESTOS; and irradiation of the CERVIX UTERI.
Morphological abnormalities of the cervical EPITHELIUM, usually revealed in PAP SMEAR, which do not meet the criteria for squamous CERVICAL INTRAEPITHELIAL NEOPLASIA or SQUAMOUS CELL CARCINOMAS of the CERVIX . It may be a sign of infection with certain types of human papillomavirus (HPV).or sign of a benign (not cancer) growth, such as a cyst or polyp or, in menopausal women, of low hormone levels. More testing, such as HPV test, may be needed.
Tumors or cancer of the UTERINE CERVIX.
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Cervical cancer is a malignant neoplasm of the cervix uteri or cervical area. Symptoms include vaginal bleeding, but may not present until later stages of the cancer. Cervical cancer can be treated using surgery (including local excision) in early stages...