Now Available: Final Rule for FDAAA 801 and NIH Policy on Clinical Trial Reporting

Combination Chemotherapy Plus Radiation Therapy in Treating Patients With Stage III or Stage IV Endometrial Cancer

This study has been completed.
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Gynecologic Oncology Group
ClinicalTrials.gov Identifier:
NCT00005830
First received: June 2, 2000
Last updated: December 29, 2014
Last verified: December 2014

June 2, 2000
December 29, 2014
July 2000
July 2009   (final data collection date for primary outcome measure)
  • Number of patients completing the prescribed therapy [ Time Frame: Up to 9 weeks ] [ Designated as safety issue: No ]
  • Frequency and severity of acute adverse effects as assessed by CTEP CTC version 2.0 [ Time Frame: 3 weeks ] [ Designated as safety issue: Yes ]
  • Frequency and severity of chronic adverse effects as assessed by CTEP CTC version 2.0 [ Time Frame: Up to 5 years after completion of study treatment ] [ Designated as safety issue: Yes ]
  • Frequency of severe and life threatening bowel, hepatic, and hematologic toxicity as assessed by CTEP CTC version 2.0 [ Time Frame: Up to 9 weeks ] [ Designated as safety issue: Yes ]
Not Provided
Complete list of historical versions of study NCT00005830 on ClinicalTrials.gov Archive Site
Reason for discontinuing study therapy [ Time Frame: Up to 9 weeks ] [ Designated as safety issue: No ]
Not Provided
Not Provided
Not Provided
 
Combination Chemotherapy Plus Radiation Therapy in Treating Patients With Stage III or Stage IV Endometrial Cancer
Phase I Toxicity Trial of Doxorubicin-Cisplatin Followed by Whole Abdominal Irradiation for Advanced Endometrial Carcinoma
Phase I trial to study the effectiveness of combination chemotherapy plus radiation therapy in treating women who have stage III or stage IV endometrial cancer. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Combining chemotherapy with radiation therapy may kill more tumor cells.

OBJECTIVES:

I. Determine the feasibility of doxorubicin and cisplatin followed by whole abdominal radiotherapy in patients with stage III or IV endometrial cancer.

II. Determine the acute and chronic toxic effects, in particular, severe and life-threatening gastrointestinal, hepatic, and hematologic toxic effects, of this regimen in these patients.

OUTLINE: This is a multicenter study.

Patients receive doxorubicin IV and cisplatin IV on day 1. Treatment repeats every 3 weeks for 3 courses. Patients then undergo whole abdominal radiotherapy 5 days a week for 4-6 weeks.

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

PROJECTED ACCRUAL: A total of 21-53 patients will be accrued for this study within 3.5 years.

Interventional
Phase 1
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Endometrial Adenocarcinoma
  • Endometrial Clear Cell Adenocarcinoma
  • Endometrial Serous Adenocarcinoma
  • Stage III Uterine Corpus Cancer
  • Stage IV Uterine Corpus Cancer
  • Drug: Doxorubicin Hydrochloride
    Given IV
  • Drug: Cisplatin
    Given IV
  • Radiation: Radiation Therapy
    Undergo radiation therapy
    Other Names:
    • Cancer Radiotherapy
    • Irradiate
    • Irradiated
    • Irradiation
    • RT
Experimental: Treatment (doxorubicin, cisplatin, radiation therapy)
Patients receive doxorubicin IV and cisplatin IV on day 1. Treatment repeats every 3 weeks for 3 courses. Patients then undergo whole abdominal radiotherapy 5 days a week for 4-6 weeks.
Interventions:
  • Drug: Doxorubicin Hydrochloride
  • Drug: Cisplatin
  • Radiation: Radiation Therapy
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
31
Not Provided
July 2009   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Histologically confirmed endometrial cancer including 1 of the following subtypes:

    • Clear cell carcinoma
    • Serous papillary carcinoma
    • Endometrioid adenocarcinoma
  • Stage III or IV disease

    • Positive adnexa
    • Metastases to serosa, bowel mucosa, abdomen
    • Positive pelvic or paraaortic nodes
    • Positive pelvic washings or vaginal involvement within the radiation port
  • Tumor must be surgically reduced to 2 cm or less within 8 weeks of study entry

    • Must have had a hysterectomy and bilateral salpingo oophorectomy
  • No recurrent disease
  • No distant metastases outside of abdominopelvic area, including:

    • Parenchymal liver metastases
    • Lung metastases
    • Positive inguinal lymph nodes
    • Positive supraclavicular nodes
    • Pleural effusion with malignant cytology
  • 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 upper limit of normal (ULN)
  • SGOT and alkaline phosphatase no greater than 3 times ULN
  • Creatinine no greater than ULN
  • Cardiac ejection fraction greater than 50%
  • No other prior or concurrent malignancy within the past 5 years except nonmelanoma skin cancer
  • No prior chemotherapy
  • No prior pelvic or abdominal radiotherapy
  • No prior radiotherapy for other prior malignancy
Female
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00005830
GOG-9908, NCI-2012-02332, CDR0000067844, GOG-9908, GOG-9908, U10CA027469
Not Provided
Not Provided
Not Provided
Gynecologic Oncology Group
Gynecologic Oncology Group
National Cancer Institute (NCI)
Principal Investigator: Jeffrey Fowler 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