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

This study has been completed.
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Gynecologic Oncology Group
ClinicalTrials.gov Identifier:
First received: February 5, 2003
Last updated: December 29, 2014
Last verified: December 2014
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.

Condition Intervention Phase
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
Drug: Topotecan Hydrochloride Liposomes
Radiation: 3-Dimensional Conformal Radiation Therapy
Drug: Cisplatin
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment

Resource links provided by NLM:

Further study details as provided by Gynecologic Oncology Group:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Site of treatment failure [ Time Frame: Up to 5 years ] [ Designated as safety issue: No ]
    Identified as local versus distant.

Enrollment: 11
Study Start Date: September 2007
Primary Completion Date: January 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Treatment (topotecan hydrochloride, radiation, cisplatin)
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 Liposomes
Given IV
Other Name: Brakiva
Radiation: 3-Dimensional Conformal Radiation Therapy
Other Names:
  • 3D-CRT
  • Conformal Therapy
  • Radiation Conformal Therapy
Drug: Cisplatin
Given IV

Detailed Description:


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.


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.


Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00054444

United States, Illinois
University of Chicago Comprehensive Cancer Center
Chicago, Illinois, United States, 60637
United States, Iowa
University of Iowa Hospitals and Clinics
Iowa City, Iowa, United States, 52242
United States, Missouri
University of Missouri - Ellis Fischel
Columbia, Missouri, United States, 65212
United States, New Jersey
Cooper Hospital University Medical Center
Camden, New Jersey, United States, 08103
United States, Ohio
MetroHealth Medical Center
Cleveland, Ohio, United States, 44109
Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical Center
Columbus, Ohio, United States, 43210
Riverside Methodist Hospital
Columbus, Ohio, United States, 43214
United States, Oklahoma
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, United States, 73104
Cancer Care Associates-Midtown
Tulsa, Oklahoma, United States, 74104
Tulsa Cancer Institute
Tulsa, Oklahoma, United States, 74146
Sponsors and Collaborators
Gynecologic Oncology Group
National Cancer Institute (NCI)
Principal Investigator: Peter Rose Gynecologic Oncology Group
  More Information

No publications provided

Responsible Party: Gynecologic Oncology Group
ClinicalTrials.gov Identifier: NCT00054444     History of Changes
Other Study ID Numbers: GOG-9913, NCI-2009-00617, CDR0000270680, GOG-9913, GOG-9913, GOG-9913, U10CA027469
Study First Received: February 5, 2003
Last Updated: December 29, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Carcinoma, Squamous Cell
Uterine Cervical Neoplasms
Genital Diseases, Female
Genital Neoplasms, Female
Neoplasms by Histologic Type
Neoplasms by Site
Neoplasms, Glandular and Epithelial
Neoplasms, Squamous Cell
Urogenital Neoplasms
Uterine Cervical Diseases
Uterine Diseases
Uterine Neoplasms
Antineoplastic Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Radiation-Sensitizing Agents
Therapeutic Uses
Topoisomerase I Inhibitors
Topoisomerase Inhibitors

ClinicalTrials.gov processed this record on November 25, 2015