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

This study has been completed.
Sponsor:
Collaborator:
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
  Purpose

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.


Condition Intervention Phase
Endometrial Adenocarcinoma
Endometrial Clear Cell Adenocarcinoma
Endometrial Serous Adenocarcinoma
Stage III Uterine Corpus Cancer
Stage IV Uterine Corpus Cancer
Drug: Doxorubicin Hydrochloride
Drug: Cisplatin
Radiation: Radiation Therapy
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase I Toxicity Trial of Doxorubicin-Cisplatin Followed by Whole Abdominal Irradiation for Advanced Endometrial Carcinoma

Resource links provided by NLM:


Further study details as provided by Gynecologic Oncology Group:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • Reason for discontinuing study therapy [ Time Frame: Up to 9 weeks ] [ Designated as safety issue: No ]

Enrollment: 31
Study Start Date: July 2000
Primary Completion Date: July 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
Drug: Doxorubicin Hydrochloride
Given IV
Drug: Cisplatin
Given IV
Radiation: Radiation Therapy
Undergo radiation therapy
Other Names:
  • Cancer Radiotherapy
  • Irradiate
  • Irradiated
  • Irradiation
  • RT

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  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: NCT00005830

Locations
United States, Pennsylvania
Gynecologic Oncology Group
Philadelphia, Pennsylvania, United States, 19103
Sponsors and Collaborators
Gynecologic Oncology Group
Investigators
Principal Investigator: Jeffrey Fowler Gynecologic Oncology Group
  More Information

No publications provided

Responsible Party: Gynecologic Oncology Group
ClinicalTrials.gov Identifier: NCT00005830     History of Changes
Other Study ID Numbers: GOG-9908, NCI-2012-02332, CDR0000067844, GOG-9908, GOG-9908, U10CA027469
Study First Received: June 2, 2000
Last Updated: December 29, 2014
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Adenocarcinoma
Adenocarcinoma, Clear Cell
Cystadenocarcinoma, Serous
Uterine Neoplasms
Carcinoma
Cystadenocarcinoma
Genital Diseases, Female
Genital Neoplasms, Female
Neoplasms
Neoplasms by Histologic Type
Neoplasms by Site
Neoplasms, Cystic, Mucinous, and Serous
Neoplasms, Glandular and Epithelial
Urogenital Neoplasms
Uterine Diseases
Doxorubicin
Liposomal doxorubicin
Antibiotics, Antineoplastic
Antineoplastic Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses
Topoisomerase II Inhibitors
Topoisomerase Inhibitors

ClinicalTrials.gov processed this record on March 25, 2015