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Radiation Therapy Plus Cisplatin and Gemcitabine in Treating Patients With Cervical Cancer

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00068549
First Posted: September 11, 2003
Last Update Posted: December 25, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Gynecologic Oncology Group
  Purpose
This phase I trial is studying the side effects and best dose of gemcitabine when given together with radiation therapy and cisplatin in treating patients with cervical cancer that has not spread beyond the pelvis. Radiation therapy uses high-energy x-rays to damage tumor cells. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining cisplatin with gemcitabine may make the tumor cells more sensitive to radiation therapy and may kill more tumor cells.

Condition Intervention Phase
Cervical Adenocarcinoma Cervical Adenosquamous Carcinoma Cervical Small Cell Carcinoma 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: Gemcitabine Hydrochloride Drug: Cisplatin Radiation: Radiation Therapy Radiation: Internal Radiation Therapy Phase 1

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase I Study of Whole Pelvic Radiation Therapy With Concomitant Cisplatin and Gemcitabine Chemotherapy in Patients With Cervical Carcinoma (Stages I-IV) Limited to the Pelvis

Resource links provided by NLM:


Further study details as provided by Gynecologic Oncology Group:

Primary Outcome Measures:
  • Incidence of acute toxicity using the 21 major categories of the CTEP CTC version 2.0 [ Time Frame: Up to 30 days after completion of radiation therapy ]
  • Incidence of chronic toxicity using the CTC RTOG/EORTC late radiation morbidity scoring scheme [ Time Frame: Up to 5 years ]
  • Dose of each drug [ Time Frame: Up to 5 years ]
  • Number of cycles received [ Time Frame: Up to 5 years ]

Secondary Outcome Measures:
  • Site (local/distant) of treatment failure [ Time Frame: Up to 5 years ]
  • Progression-free survival [ Time Frame: Up to 5 years ]
  • Overall survival [ Time Frame: Up to 5 years ]

Enrollment: 13
Study Start Date: October 2003
Primary Completion Date: January 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Treatment
Patients receive gemcitabine IV over 30 minutes and cisplatin IV over 1 hour on days 1, 8, 15, 22, 29, and 36 in the absence of disease progression or unacceptable toxicity. Patients also undergo external whole pelvis radiotherapy once daily on days 1-5, 8-13, 15-20, 22-27, and 29-34. After completion of external beam radiotherapy, patients undergo intracavitary radiotherapy and parametrial radiotherapy. The total elapsed time for completion of all radiotherapy is not more than 8 weeks.
Drug: Gemcitabine Hydrochloride
Given IV
Other Names:
  • dFdC
  • dFdCyd
Drug: Cisplatin
Given IV
Radiation: Radiation Therapy
Undergo whole pelvis radiotherapy
Other Names:
  • Cancer Radiotherapy
  • Irradiate
  • Irradiated
  • Irradiation
  • RT
Radiation: Internal Radiation Therapy
Undergo brachytherapy
Other Names:
  • Brachytherapy
  • Internal Radiation
  • Internal Radiation Brachytherapy
  • Radiation Brachytherapy

Detailed Description:

PRIMARY OBJECTIVES:

I. Determine the toxicity of pelvic radiotherapy and concurrent cisplatin and gemcitabine in patients with cervical carcinoma limited to the pelvis.

II. Determine the maximum tolerated dose (MTD) of gemcitabine in combination with cisplatin and pelvic radiotherapy in these patients.

SECONDARY OBJECTIVES:

I. Determine the progression-free and overall survival of patients treated with gemcitabine at the MTD in this regimen.

II. Determine the site of recurrence, local versus distant, in patients treated with this regimen.

OUTLINE: This is a multicenter, dose-escalation study of gemcitabine.

Patients receive gemcitabine IV over 30 minutes and cisplatin IV over 1 hour on days 1, 8, 15, 22, 29, and 36 in the absence of disease progression or unacceptable toxicity. Patients also undergo external whole pelvis radiotherapy once daily on days 1-5, 8-13, 15-20, 22-27, and 29-34. After completion of external beam radiotherapy, patients undergo intracavitary radiotherapy and parametrial radiotherapy. The total elapsed time for completion of all radiotherapy is not more than 8 weeks.

Cohorts of 3-6 patients receive escalating doses of gemcitabine 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.

Patients are followed every 3 months for 2 years and then every 6 months for 3 years.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Histologically confirmed primary invasive carcinoma of the uterine cervix

    • Previously untreated disease
    • Any cell type
    • Stage IB_2, IIA, IIB, IIIA, IIIB, or IVA
  • Para-aortic lymph nodes negative by radiologic evaluation or by biopsy if CT scan is suspicious for adenopathy
  • No known metastases to scalene nodes or other organs outside the radiotherapy field
  • Study enrollment within 8 weeks of diagnosis
  • Performance status - GOG 0-2
  • Absolute neutrophil count at least 1,500/mm^3
  • Platelet count at least 100,000/mm^3
  • Bilirubin no greater than 1.5 times normal
  • SGOT no greater than 3 times normal
  • Creatinine less than 2.0 mg/dL
  • No renal abnormalities (e.g., pelvic kidney, horseshoe kidney, or renal transplantation) that would require modification of radiotherapy fields
  • No ureteral obstruction allowed unless treated with stent or nephrostomy tube
  • Not pregnant
  • Fertile patients must use effective contraception
  • No septicemia or severe infection
  • No circumstance that would preclude study completion or follow-up
  • No other malignancy within the past 5 years except nonmelanoma skin cancer
  • No prior cytotoxic chemotherapy
  • No prior pelvic or abdominal radiotherapy
  • No prior therapy for this malignancy
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00068549


Locations
United States, Pennsylvania
Gynecologic Oncology Group
Philadelphia, Pennsylvania, United States, 19103
Sponsors and Collaborators
Gynecologic Oncology Group
National Cancer Institute (NCI)
Investigators
Principal Investigator: Peter Rose Gynecologic Oncology Group
  More Information

Responsible Party: Gynecologic Oncology Group
ClinicalTrials.gov Identifier: NCT00068549     History of Changes
Other Study ID Numbers: GOG-9912
NCI-2012-02553 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
CDR0000327715
GOG-9912 ( Other Identifier: Gynecologic Oncology Group )
GOG-9912 ( Other Identifier: CTEP )
U10CA027469 ( U.S. NIH Grant/Contract )
First Submitted: September 10, 2003
First Posted: September 11, 2003
Last Update Posted: December 25, 2014
Last Verified: December 2014

Additional relevant MeSH terms:
Carcinoma
Carcinoma, Squamous Cell
Adenocarcinoma
Uterine Cervical Neoplasms
Carcinoma, Adenosquamous
Carcinoma, Small Cell
Small Cell Lung Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Squamous Cell
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Uterine Cervical Diseases
Uterine Diseases
Genital Diseases, Female
Neoplasms, Complex and Mixed
Carcinoma, Bronchogenic
Bronchial Neoplasms
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Lung Diseases
Respiratory Tract Diseases
Gemcitabine
Cisplatin
Antineoplastic Agents
Antimetabolites, Antineoplastic