NCT00054444

Brief Summary

This phase I trial is studying the side effects and best way to give radiation therapy when given together with topotecan and cisplatin in treating patients with locally advanced cervical cancer. This trial is also studying the best dose of topotecan when given in this regimen. Radiation therapy uses high-energy x-rays to damage tumor cells. Drugs used in chemotherapy, such as topotecan and cisplatin, use different ways to stop tumor cells from dividing so they stop growing or die. Combining radiation therapy with chemotherapy may kill more tumor cells.

Trial Health

80
On Track

Trial Health Score

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

Enrollment
11

participants targeted

Target at below P25 for phase_1

Geographic Reach
1 country

10 active sites

Status
completed

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

First Submitted

Initial submission to the registry

February 5, 2003

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 6, 2003

Completed
4.6 years until next milestone

Study Start

First participant enrolled

September 1, 2007

Completed
4.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2012

Completed
Last Updated

December 31, 2014

Status Verified

December 1, 2014

Enrollment Period

4.3 years

First QC Date

February 5, 2003

Last Update Submit

December 29, 2014

Conditions

Cervical AdenocarcinomaCervical Squamous Cell CarcinomaStage IB Cervical CancerStage IIA Cervical CancerStage IIB Cervical CancerStage III Cervical CancerStage IVA Cervical Cancer

Outcome Measures

Primary Outcomes (2)

  • Incidence of patients with acute toxicity assessed by Common Terminology Criteria for Adverse Events version 3.0

    Up to 30 days after completion of radiation therapy

  • Incidence of patients with chronic toxicity assessed by Common Toxicity Criteria Radiation Therapy Oncology Group/European Organisation for Research and Treatment of Cancer (CTC RTOG/EORTC)

    Up to 5 years

Secondary Outcomes (1)

  • Site of treatment failure

    Up to 5 years

Study Arms (1)

Treatment (topotecan hydrochloride, radiation, cisplatin)

EXPERIMENTAL

Patients undergo radiotherapy 5 days a week for 6 weeks. Patients receive cisplatin IV and topotecan IV over 30 minutes once weekly for a total of 6 weeks in the absence of disease progression or unacceptable toxicity.

Drug: Topotecan Hydrochloride LiposomesRadiation: 3-Dimensional Conformal Radiation TherapyDrug: Cisplatin

Interventions

Topotecan Hydrochloride LiposomesDRUG

Given IV

Also known as: Brakiva
Treatment (topotecan hydrochloride, radiation, cisplatin)
3-Dimensional Conformal Radiation TherapyRADIATION
Also known as: 3D-CRT, Conformal Therapy, Radiation Conformal Therapy
Treatment (topotecan hydrochloride, radiation, cisplatin)
CisplatinDRUG

Given IV

Treatment (topotecan hydrochloride, radiation, cisplatin)

Eligibility Criteria

Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Histologically confirmed primary invasive carcinoma of the uterine cervix
  • Stages IB2, II, IIIB, and IVA disease
  • Any cell type
  • No known metastasis to scalene nodes or organs outside the radiation field
  • No known intraperitoneal metastases
  • No evidence of extrapelvic disease based on negative CT or PET scan
  • Must enroll within 8 weeks of diagnosis
  • Performance status - GOG 0-2
  • Absolute neutrophil count ≥ 1,500/mm\^3
  • Platelet count ≥ 100,000/mm\^3
  • Bilirubin ≤ 1.5 times upper limit of normal (ULN)
  • SGOT ≤ 2.5 times ULN
  • Alkaline phosphatase ≤ 2.5 times ULN
  • Creatinine normal
  • Creatinine clearance \> 50 mL/min
  • +13 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (10)

University of Chicago Comprehensive Cancer Center

Chicago, Illinois, 60637, United States

Location

University of Iowa Hospitals and Clinics

Iowa City, Iowa, 52242, United States

Location

University of Missouri - Ellis Fischel

Columbia, Missouri, 65212, United States

Location

Cooper Hospital University Medical Center

Camden, New Jersey, 08103, United States

Location

MetroHealth Medical Center

Cleveland, Ohio, 44109, United States

Location

Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical Center

Columbus, Ohio, 43210, United States

Location

Riverside Methodist Hospital

Columbus, Ohio, 43214, United States

Location

University of Oklahoma Health Sciences Center

Oklahoma City, Oklahoma, 73104, United States

Location

Cancer Care Associates-Midtown

Tulsa, Oklahoma, 74104, United States

Location

Tulsa Cancer Institute

Tulsa, Oklahoma, 74146, United States

Location

MeSH Terms

Conditions

Uterine Cervical Neoplasms

Interventions

Radiotherapy, ConformalCisplatin

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)

Radiotherapy, Computer-AssistedRadiotherapyTherapeuticsChlorine CompoundsInorganic ChemicalsNitrogen CompoundsPlatinum Compounds

Study Officials

  • Peter Rose

    Gynecologic Oncology Group

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
NETWORK
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 5, 2003

First Posted

February 6, 2003

Study Start

September 1, 2007

Primary Completion

January 1, 2012

Last Updated

December 31, 2014

Record last verified: 2014-12

Locations

US(10)