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

Endometrial Adenocarcinoma Clinical Trial

Official title:

Phase I Toxicity Trial of Doxorubicin-Cisplatin Followed by Whole Abdominal Irradiation for Advanced Endometrial Carcinoma

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00005830
• Other study ID #: GOG-9908
• Secondary ID: NCI-2012-02332CD
• Status: Completed
• Phase: Phase 1
• First received: June 2, 2000
• Last updated: December 29, 2014
• Start date: July 2000

Study information

• Verified date: December 2014
• Source: Gynecologic Oncology Group
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 31
• Est. primary completion date: July 2009
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Study Design

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Adenocarcinoma
• Endometrial Adenocarcinoma
• Endometrial Clear Cell Adenocarcinoma
• Endometrial Serous Adenocarcinoma
• Stage III Uterine Corpus Cancer
• Stage IV Uterine Corpus Cancer
• Uterine Neoplasms

Intervention

Drug:
• Doxorubicin Hydrochloride
Given IV
• Cisplatin
Given IV

Radiation:
• Radiation Therapy
Undergo radiation therapy

Locations

Country	Name	City	State
United States	Gynecologic Oncology Group	Philadelphia	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
Gynecologic Oncology Group	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of patients completing the prescribed therapy		Up to 9 weeks	No
Primary	Frequency and severity of acute adverse effects as assessed by CTEP CTC version 2.0		3 weeks	Yes
Primary	Frequency and severity of chronic adverse effects as assessed by CTEP CTC version 2.0		Up to 5 years after completion of study treatment	Yes
Primary	Frequency of severe and life threatening bowel, hepatic, and hematologic toxicity as assessed by CTEP CTC version 2.0		Up to 9 weeks	Yes
Secondary	Reason for discontinuing study therapy		Up to 9 weeks	No