NCT00322920

Brief 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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at P25-P50 for phase_1

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2005

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

May 5, 2006

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 8, 2006

Completed
Last Updated

February 15, 2008

Status Verified

February 1, 2008

First QC Date

May 5, 2006

Last Update Submit

February 13, 2008

Conditions

Cervix Cancer

Keywords

cervical cancertopotecanStage IVB cervical cancerPersistent or recurrent cervical cancer

Outcome Measures

Primary Outcomes (1)

  • MTD of topotecan when given weekly with cisplatin

Secondary Outcomes (2)

  • Toxicity profile in patients treated with the combination of topotecan when given weekly with cisplatin

  • Response rate and time to progression

Interventions

TopotecanDRUG
CisplatinDRUG

Eligibility Criteria

Age19 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Alabama at Birmingham

Birmingham, Alabama, 35233, United States

Location

MeSH Terms

Conditions

Uterine Cervical Neoplasms

Interventions

TopotecanCisplatin

Condition Hierarchy (Ancestors)

Uterine NeoplasmsGenital Neoplasms, FemaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsUterine Cervical DiseasesUterine DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Diseases

Intervention Hierarchy (Ancestors)

CamptothecinAlkaloidsHeterocyclic CompoundsChlorine CompoundsInorganic ChemicalsNitrogen CompoundsPlatinum Compounds

Study Officials

  • J. Michael Straughn, Jr., MD

    University of Alabama at Birmingham

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

May 5, 2006

First Posted

May 8, 2006

Study Start

July 1, 2005

Last Updated

February 15, 2008

Record last verified: 2008-02

Locations

US(1)