Advertisement

Topics

Efficacy Study of Weekly Topotecan With Cisplatin in Advanced Stage or Recurrent Cervical Cancer

2014-08-27 03:44:50 | BioPortfolio

Summary

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.

Description

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.

Study Design

Allocation: Non-Randomized, Control: Uncontrolled, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Conditions

Cervix Cancer

Intervention

Topotecan, Cisplatin

Location

University of Alabama at Birmingham
Birmingham
Alabama
United States
35233

Status

Terminated

Source

University of Alabama at Birmingham

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:44:50-0400

Clinical Trials [1723 Associated Clinical Trials listed on BioPortfolio]

A Study of MK1775 in Combination With Topotecan/Cisplatin in Patients With Cervical Cancer (1775-008)

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...

Topotecan, Cisplatin, and Radiation Therapy in Treating Patients With Advanced Cervical Cancer

RATIONALE: Drugs used in chemotherapy, such as topotecan and cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from divid...

Comparative Study of Gemcitabine,Cisplatin and Radiation Versus Cisplatin and Radiation in Cancer of the Cervix

The purpose of this study is to compare the effectiveness of two methods of treating cancer of the cervix. Half the patients will receive gemcitabine plus cisplatin while undergoing radiat...

Topotecan and Paclitaxel in Treating Patients With Recurrent or Metastatic Cancer of the Cervix

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. PURPOSE: Ph...

Paclitaxel and Cisplatin or Topotecan With or Without Bevacizumab in Treating Patients With Stage IVB, Recurrent, or Persistent Cervical Cancer

This randomized phase III trial studies the side effects of paclitaxel when given together with cisplatin or topotecan with or without bevacizumab and to compare how well they work in trea...

PubMed Articles [13514 Associated PubMed Articles listed on BioPortfolio]

Topotecan monotherapy for the treatment of relapsed small cell lung cancer in elderly patients: A retrospective analysis.

Topotecan is one of the most active chemotherapeutic drugs for small cell lung cancer (SCLC). However, its efficacy in elderly patients with SCLC has not been validated. This study evaluated the feasi...

Topotecan effect on the structure of normal and cancer plasma membrane lipid models: A multi-model approach.

Topotecan is a relatively large, planar, asymmetric and polar molecule with a lactone moiety. In neutral or basic aqueous solutions, this ring opens forming the carboxylate form of Topotecan that is b...

Response to Combination Chemotherapy With Paclitaxel/Ifosfamide/Platinum Versus Paclitaxel/Platinum for Patients With Metastatic, Recurrent, or Persistent Carcinoma of the Uterine Cervix: A Retrospective Analysis.

Paclitaxel/ifosfamide/cisplatin triplet has shown a higher response rate than paclitaxel/cisplatin doublet, but the toxicity profile hindered the use of the triplet regimen. In this study, we adjusted...

A randomised phase II trial of capecitabine plus cisplatin versus S-1 plus cisplatin as a first-line treatment for advanced gastric cancer: Capecitabine plus cisplatin ascertainment versus S-1 plus cisplatin randomised PII trial (XParTS II).

Capecitabine plus cisplatin (XP) is a standard global regimen, while S-1 plus cisplatin (SP) is a Japanese standard for first-line treatment of advanced gastric cancer (AGC). We conducted a phase II t...

EZH2 promotes cisplatin resistance by reducing cellular platinum accumulation.

Enhancer of zeste homolog 2 (EZH2), which is overexpressed in a wide range of tumors, contributes to ovarian cancer malignancy in several different ways. We aimed to illustrate the role of EZH2 in ova...

Medical and Biotech [MESH] Definitions

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.

More From BioPortfolio on "Efficacy Study of Weekly Topotecan With Cisplatin in Advanced Stage or Recurrent Cervical Cancer"

Advertisement
Quick Search
Advertisement
Advertisement

 

Relevant Topics

Public Health
Alternative Medicine Cleft Palate Complementary & Alternative Medicine Congenital Diseases Dentistry Ear Nose & Throat Food Safety Geriatrics Healthcare Hearing Medical Devices MRSA Muscular Dyst...

Women's Health
Women's Health - key topics include breast cancer, pregnancy, menopause, stroke Follow and track Women's Health News on BioPortfolio: Women's Health News RSS Women'...

Cervical Cancer
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...


Searches Linking to this Trial