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

Phase 1

Completed

• Conditions: Endometrial Serous Adenocarcinoma; Stage III Uterine Corpus Cancer; Endometrial Clear Cell Adenocarcinoma; Endometrial Adenocarcinoma; Stage IV Uterine Corpus Cancer
• Interventions: Drug: Doxorubicin Hydrochloride; Drug: Cisplatin; Radiation: Radiation Therapy

• Registration Number: NCT00005830
• Lead Sponsor: Gynecologic Oncology Group

Brief Summary

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.

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.

Study Timeline

• Study First Submitted: 2000-06-02
• Study Start: 2000-07
• Study First Submitted QC: 2003-01-26
• Study First Posted: 2003-01-27
• Primary Completion: 2009-07
• Status Verified: 2014-12
• Last Update Submitted: 2014-12-29
• Last Update Posted: 2014-12-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 31

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Treatment (doxorubicin, cisplatin, radiation therapy)	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.
Treatment (doxorubicin, cisplatin, radiation therapy)	Doxorubicin Hydrochloride	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.
Treatment (doxorubicin, cisplatin, radiation therapy)	Cisplatin	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.

Primary Outcome Measures

Name	Time	Method
Frequency of severe and life threatening bowel, hepatic, and hematologic toxicity as assessed by CTEP CTC version 2.0	Up to 9 weeks
Number of patients completing the prescribed therapy	Up to 9 weeks
Frequency and severity of acute adverse effects as assessed by CTEP CTC version 2.0	3 weeks
Frequency and severity of chronic adverse effects as assessed by CTEP CTC version 2.0	Up to 5 years after completion of study treatment

Secondary Outcome Measures

Name	Time	Method
Reason for discontinuing study therapy	Up to 9 weeks

Trial Locations

Locations (1)

Gynecologic Oncology Group; 🇺🇸 Philadelphia, Pennsylvania, United States