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Completed

NCT Number: NCT00005830

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

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 1

Primary location

Gynecologic Oncology Group

Philadelphia, Pennsylvania, 19103, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Doxorubicin hydrochloride

Drug

Given IV

Cisplatin

Drug

Given IV

radiation therapy

Radiation

Undergo radiation therapy

Other names: Cancer Radiotherapy, Irradiate, Irradiated, Irradiation, RT

Primary outcomes

  1. Number of patients completing the prescribed therapy

    Time frame: Up to 9 weeks

  2. Frequency and severity of acute adverse effects as assessed by CTEP CTC version 2.0

    Time frame: 3 weeks

  3. 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

  4. 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

Secondary outcomes

  1. Reason for discontinuing study therapy

    Time frame: Up to 9 weeks

Sponsors and collaborators

Lead sponsor

Gynecologic Oncology Group

Network

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study title

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

Important dates

Study start
2000
Primary completion
2009
First posted
Jan 27, 2003
Registry last updated
Dec 31, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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