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

Gynecologic Oncology Group (GOG)

Status and phase: Completed; Phase 1

Conditions: Endometrial Adenocarcinoma; Stage IV Uterine Corpus Cancer; Endometrial Serous Adenocarcinoma; Endometrial Clear Cell Adenocarcinoma; Stage III Uterine Corpus Cancer

Treatments: Radiation: Radiation Therapy; Drug: Doxorubicin Hydrochloride; Drug: Cisplatin

Study type: Interventional

Funder types: NETWORK; NIH

Identifiers

NCT00005830

U10CA027469 (U.S. NIH Grant/Contract)

GOG-9908 (Other Identifier)

CDR0000067844

NCI-2012-02332 (Registry Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 31 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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31 participants in 1 patient group

Treatment (doxorubicin, cisplatin, radiation therapy)

Experimental group

Description:

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:

Drug: Cisplatin

Drug: Doxorubicin Hydrochloride

Radiation: Radiation Therapy