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

This study has been terminated.
(Low accrual)
Sponsor:
ClinicalTrials.gov Identifier:
NCT00322920
First Posted: May 8, 2006
Last Update Posted: February 15, 2008
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
GlaxoSmithKline
Information provided by:
University of Alabama at Birmingham
  Purpose
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.

Condition Intervention Phase
Cervix Cancer Drug: Topotecan Drug: Cisplatin Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase I Study of Weekly Topotecan With Cisplatin for the Management of Advanced Stage or Recurrent Carcinoma of the Cervix

Resource links provided by NLM:


Further study details as provided by University of Alabama at Birmingham:

Primary Outcome Measures:
  • MTD of topotecan when given weekly with cisplatin

Secondary Outcome Measures:
  • Toxicity profile in patients treated with the combination of topotecan when given weekly with cisplatin
  • Response rate and time to progression

Estimated Enrollment: 30
Study Start Date: July 2005
Detailed 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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients must have persistent, recurrent, or primary Stage IVB carcinoma of the cervix not amenable to curative therapy with either surgery and/or radiation.
  • Patients must have biopsy proven squamous cell, adenosquamous, or adenocarcinoma histology.
  • Patients do not require measurable disease.
  • Patients must have adequate organ function defined by laboratory work.
  • Patients must have an Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1.
  • Patients must have recovered from any effects attributable to surgery, radiation, or chemoradiotherapy. A minimum of six weeks shall have passed since the last administration of chemoradiotherapy or three weeks for radiation therapy alone.
  • Patients must be free of clinically significant infections.
  • Patients must be age 19 or greater and have signed informed consent.

Exclusion Criteria:

  • Patients who are pregnant or lactating.
  • Patients with history of other malignancies (except non-melanoma skin cancer) within the last 5 years are ineligible.
  • Patients with non-squamous, adenosquamous, or adenocarcinoma histology.
  • Patients with bilateral hydronephrosis that cannot be alleviated by ureteral stents or percutaneous drainage.
  • Patients currently receiving any or having received other investigational agents within the last 30 days are ineligible.
  • Patients with known hypersensitivity to topotecan or cisplatin.
  • Patients with craniospinal metastases.
  • Patients with uncontrolled current illness including, but not limited to, ongoing or active infection, unstable angina pectoris, cardiac arrhythmia, serious peripheral neuropathy, or psychiatric illness/social situations that would limit or preclude compliance with study requirements are ineligible.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00322920


Locations
United States, Alabama
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35233
Sponsors and Collaborators
University of Alabama at Birmingham
GlaxoSmithKline
Investigators
Principal Investigator: J. Michael Straughn, Jr., MD University of Alabama at Birmingham
  More Information

ClinicalTrials.gov Identifier: NCT00322920     History of Changes
Other Study ID Numbers: 104799
First Submitted: May 5, 2006
First Posted: May 8, 2006
Last Update Posted: February 15, 2008
Last Verified: February 2008

Keywords provided by University of Alabama at Birmingham:
cervical cancer
topotecan
Stage IVB cervical cancer
Persistent or recurrent cervical cancer

Additional relevant MeSH terms:
Uterine Cervical Neoplasms
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Uterine Cervical Diseases
Uterine Diseases
Genital Diseases, Female
Cisplatin
Topotecan
Antineoplastic Agents
Topoisomerase I Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action