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

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Gynecologic Oncology Group
ClinicalTrials.gov Identifier:
NCT00054444
First received: February 5, 2003
Last updated: December 29, 2014
Last verified: December 2014

February 5, 2003
December 29, 2014
September 2007
January 2012   (final data collection date for primary outcome measure)
  • 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 ]
Not Provided
Complete list of historical versions of study NCT00054444 on ClinicalTrials.gov Archive Site
Site of treatment failure [ Time Frame: Up to 5 years ] [ Designated as safety issue: No ]
Identified as local versus distant.
Not Provided
Not Provided
Not Provided
 
Radiation Therapy and Chemotherapy in Treating Patients With Locally Advanced Cervical Cancer
A PHASE I STUDY OF PELVIC RADIATION THERAPY WITH CONCOMITANT WEEKLY CISPLATIN AND TOPOTECAN CHEMOTHERAPY IN PATIENTS WITH CERVICAL CARCINOMA WITHOUT EXTRA-PELVIC METASTASIS

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.

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.

Interventional
Phase 1
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • 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
    Given IV
    Other Names:
    • Brakiva
    • topotecan hydrochloride liposomes
  • Radiation: 3-Dimensional Conformal Radiation Therapy
    Other Names:
    • 3D-CRT
    • Conformal Therapy
    • Radiation Conformal Therapy
  • Drug: Cisplatin
    Given IV
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.
Interventions:
  • Drug: Topotecan Hydrochloride Liposomes
  • Radiation: 3-Dimensional Conformal Radiation Therapy
  • Drug: Cisplatin
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
11
Not Provided
January 2012   (final data collection date for primary outcome measure)

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
Female
Not Provided
No
Contact information is only displayed when the study is recruiting subjects
United States
Australia,   Canada,   Japan,   Norway,   United Kingdom
 
NCT00054444
GOG-9913, NCI-2009-00617, CDR0000270680, GOG-9913, GOG-9913, GOG-9913, U10CA027469
Not Provided
Gynecologic Oncology Group
Gynecologic Oncology Group
National Cancer Institute (NCI)
Principal Investigator: Peter Rose Gynecologic Oncology Group
Gynecologic Oncology Group
December 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP