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Radiation Therapy and Chemotherapy in Treating Patients With Locally Advanced Cervical Cancer

Primary Purpose

Cervical Adenocarcinoma, Cervical Squamous Cell Carcinoma, Stage IB Cervical Cancer

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Topotecan Hydrochloride Liposomes
3-Dimensional Conformal Radiation Therapy
Cisplatin
Sponsored by
Gynecologic Oncology Group
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cervical Adenocarcinoma

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria: 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 Prior ureteral obstruction allowed provided stent or nephrostomy tube has been placed No renal abnormalities, such as pelvic kidney, horseshoe kidney, or prior renal transplantation that would require modification of radiation fields Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception No other malignancy within the past 5 years except nonmelanoma skin cancer No septicemia or severe infection No other medical or psychiatric condition that would preclude study compliance No prior chemotherapy for any prior malignancy No prior cytotoxic chemotherapy for this malignancy No prior radiotherapy for any prior malignancy No prior pelvic or abdominal radiotherapy for this malignancy No prior therapy for this malignancy

Sites / Locations

  • University of Chicago Comprehensive Cancer Center
  • University of Iowa Hospitals and Clinics
  • University of Missouri - Ellis Fischel
  • Cooper Hospital University Medical Center
  • MetroHealth Medical Center
  • Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical Center
  • Riverside Methodist Hospital
  • University of Oklahoma Health Sciences Center
  • Cancer Care Associates-Midtown
  • Tulsa Cancer Institute

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Treatment (topotecan hydrochloride, radiation, cisplatin)

Arm Description

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Site of treatment failure
Identified as local versus distant.

Full Information

First Posted
February 5, 2003
Last Updated
December 29, 2014
Sponsor
Gynecologic Oncology Group
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00054444
Brief Title
Radiation Therapy and Chemotherapy in Treating Patients With Locally Advanced Cervical Cancer
Official Title
A PHASE I STUDY OF PELVIC RADIATION THERAPY WITH CONCOMITANT WEEKLY CISPLATIN AND TOPOTECAN CHEMOTHERAPY IN PATIENTS WITH CERVICAL CARCINOMA WITHOUT EXTRA-PELVIC METASTASIS
Study Type
Interventional

2. Study Status

Record Verification Date
December 2014
Overall Recruitment Status
Completed
Study Start Date
September 2007 (undefined)
Primary Completion Date
January 2012 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Gynecologic Oncology Group
Collaborators
National Cancer Institute (NCI)

4. Oversight

5. Study Description

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.
Detailed Description
PRIMARY OBJECTIVES: I. Determine the safety and tolerability of pelvic radiotherapy, cisplatin, and topotecan in patients with locally advanced cervical cancer. II. Determine the maximum tolerated dose (MTD) of topotecan when administered in this regimen in this patient population. SECONDARY OBJECTIVES: I. Determine the site of recurrence (local vs distant) in patients treated with this regimen. OUTLINE: This is a multicenter, dose-escalation study of topotecan. 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. Cohorts of 3-6 patients receive escalating doses of topotecan until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose at which 1 of 6 patients experiences dose-limiting toxicity. Once the MTD is determined, an additional cohort of 20 patients receives treatment as above at the MTD. After completion of study treatment, patients are followed periodically for 5 years.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cervical Adenocarcinoma, Cervical Squamous Cell Carcinoma, Stage IB Cervical Cancer, Stage IIA Cervical Cancer, Stage IIB Cervical Cancer, Stage III Cervical Cancer, Stage IVA Cervical Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
11 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Treatment (topotecan hydrochloride, radiation, cisplatin)
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Topotecan Hydrochloride Liposomes
Other Intervention Name(s)
Brakiva
Intervention Description
Given IV
Intervention Type
Radiation
Intervention Name(s)
3-Dimensional Conformal Radiation Therapy
Other Intervention Name(s)
3D-CRT, Conformal Therapy, Radiation Conformal Therapy
Intervention Type
Drug
Intervention Name(s)
Cisplatin
Intervention Description
Given IV
Primary Outcome Measure Information:
Title
Incidence of patients with acute toxicity assessed by Common Terminology Criteria for Adverse Events version 3.0
Time Frame
Up to 30 days after completion of radiation therapy
Title
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)
Time Frame
Up to 5 years
Secondary Outcome Measure Information:
Title
Site of treatment failure
Description
Identified as local versus distant.
Time Frame
Up to 5 years

10. Eligibility

Sex
Female
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Prior ureteral obstruction allowed provided stent or nephrostomy tube has been placed No renal abnormalities, such as pelvic kidney, horseshoe kidney, or prior renal transplantation that would require modification of radiation fields Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception No other malignancy within the past 5 years except nonmelanoma skin cancer No septicemia or severe infection No other medical or psychiatric condition that would preclude study compliance No prior chemotherapy for any prior malignancy No prior cytotoxic chemotherapy for this malignancy No prior radiotherapy for any prior malignancy No prior pelvic or abdominal radiotherapy for this malignancy No prior therapy for this malignancy
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Peter Rose
Organizational Affiliation
Gynecologic Oncology Group
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Chicago Comprehensive Cancer Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States
Facility Name
University of Iowa Hospitals and Clinics
City
Iowa City
State/Province
Iowa
ZIP/Postal Code
52242
Country
United States
Facility Name
University of Missouri - Ellis Fischel
City
Columbia
State/Province
Missouri
ZIP/Postal Code
65212
Country
United States
Facility Name
Cooper Hospital University Medical Center
City
Camden
State/Province
New Jersey
ZIP/Postal Code
08103
Country
United States
Facility Name
MetroHealth Medical Center
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44109
Country
United States
Facility Name
Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical Center
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States
Facility Name
Riverside Methodist Hospital
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43214
Country
United States
Facility Name
University of Oklahoma Health Sciences Center
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73104
Country
United States
Facility Name
Cancer Care Associates-Midtown
City
Tulsa
State/Province
Oklahoma
ZIP/Postal Code
74104
Country
United States
Facility Name
Tulsa Cancer Institute
City
Tulsa
State/Province
Oklahoma
ZIP/Postal Code
74146
Country
United States

12. IPD Sharing Statement

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Radiation Therapy and Chemotherapy in Treating Patients With Locally Advanced Cervical Cancer

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