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.

Study Overview

• Status: Completed
• Conditions: Stage III Uterine Corpus Cancer; Stage IV Uterine Corpus Cancer; Endometrial Clear Cell Adenocarcinoma; Endometrial Serous Adenocarcinoma; Endometrial Adenocarcinoma
• Intervention / Treatment: Drug: Cisplatin; Drug: Doxorubicin Hydrochloride; Radiation: Radiation Therapy

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 Type: Interventional
• Enrollment (Actual): 31
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19103
      • Gynecologic Oncology Group

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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: Cisplatin; Given IV; Drug: Doxorubicin Hydrochloride; Given IV; Radiation: Radiation Therapy; Undergo radiation therapy; Other Names: Cancer Radiotherapy; Irradiate; Irradiated; Irradiation; RT

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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
Frequency of severe and life threatening bowel, hepatic, and hematologic toxicity as assessed by CTEP CTC version 2.0	Up to 9 weeks

Secondary Outcome Measures

Outcome Measure	Time Frame
Reason for discontinuing study therapy	Up to 9 weeks

Collaborators and Investigators

• Sponsor: Gynecologic Oncology Group
• Collaborators: National Cancer Institute (NCI)
• Investigators: Principal Investigator: Jeffrey Fowler, Gynecologic Oncology Group

Study record dates

Study Major Dates

• Study Start: July 1, 2000
• Primary Completion (Actual): July 1, 2009

Study Registration Dates

• First Submitted: June 2, 2000
• First Submitted That Met QC Criteria: January 26, 2003
• First Posted (Estimate): January 27, 2003

Study Record Updates

• Last Update Posted (Estimate): December 31, 2014
• Last Update Submitted That Met QC Criteria: December 29, 2014
• Last Verified: December 1, 2014

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Carcinoma; Neoplasms, Glandular and Epithelial; Cystadenocarcinoma; Neoplasms, Cystic, Mucinous, and Serous; Adenocarcinoma; Cystadenocarcinoma, Serous; Adenocarcinoma, Clear Cell; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antineoplastic Agents; Topoisomerase II Inhibitors; Topoisomerase Inhibitors; Antibiotics, Antineoplastic; Doxorubicin; Liposomal doxorubicin
• Other Study ID Numbers: GOG-9908 (Other Identifier: CTEP); U10CA027469 (U.S. NIH Grant/Contract); NCI-2012-02332 (Registry Identifier: CTRP (Clinical Trial Reporting Program)); CDR0000067844