Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outcomes
Outline
Trial Contact Information
Related Information
Registry Information

Alternate Title

Combination Chemotherapy in Treating Patients With Stage III, Stage IV, or Recurrent Endometrial Cancer

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase III	Treatment	Closed	18 and over	NCI	GOG-0209 NCT00063999

Special Category: CTSU trial, NCI Web site featured trial

Objectives

1. Compare the efficacy of doxorubicin, cisplatin, paclitaxel, and filgrastim (G-CSF) vs carboplatin and paclitaxel, in terms of survival, in patients with stage III or IV or recurrent endometrial cancer.
2. Determine whether estrogen/progesterone receptor status provides prognostic information in patients treated with these regimens.
3. Compare the toxicity profile of these regimens, specifically neurotoxicity and infection, in these patients.
4. Compare the quality of life of patients treated with these regimens.

Entry Criteria

Disease Characteristics:

• Histologically confirmed endometrial carcinoma
  • FIGO stage III or IV or recurrent disease



• Must know estrogen and progesterone status of the primary tumor



• Poor potential for curative treatment by radiotherapy and/or surgery



• At least 1 unidimensionally measurable lesion (for patients with stage III disease only)
  • At least 20 mm by conventional techniques (e.g., palpation, plain x-ray, CT scan, or MRI) OR at least 10 mm by spiral CT scan
  • Disease in a previously irradiated field acceptable as the only site of measurable disease only if there has been clear progression since completion of radiotherapy

Prior/Concurrent Therapy:

Biologic therapy

• Prior biologic therapy allowed
• No concurrent biologic therapy

Chemotherapy

• No prior cytotoxic chemotherapy (including radiotherapy sensitization) for this or any other malignancy

Endocrine therapy

• Prior hormonal therapy allowed
• No concurrent hormonal therapy

Radiotherapy

• See Disease Characteristics
• At least 4 weeks since prior radiotherapy to the whole pelvis or over 50% of the spine
• No concurrent radiotherapy

Surgery

• Not specified

Other

• Concurrent medications that alter cardiac conduction (e.g., digitalis, beta blockers, or calcium channel blockers) are allowed at the investigator's discretion

Patient Characteristics:

Age

• 18 and over

Performance status

• GOG 0-2

Life expectancy

• Not specified

Hematopoietic

• Absolute neutrophil count at least 1,500/mm³
• Platelet count at least 100,000/mm³

Hepatic

• Bilirubin normal
• ALT no greater than 3 times upper limit of normal

Renal

• Creatinine no greater than 1.6 mg/dL

Cardiovascular

• LVEF at least 50%
• Cardiac conduction abnormalities or dysfunction allowed at the investigator's discretion
• No third-degree or complete heart block without a pacemaker
• No uncontrolled angina
• No myocardial infarction within the past 6 months
• No New York Heart Association class II -IV heart failure
• No symptoms of congestive heart failure

Other

• Not pregnant or nursing
• Fertile patients must use effective non-hormonal contraception during and for at least 2 months after study participation
• No other invasive malignancy within the past 5 years except patients who have nonmelanoma skin cancer or have received prior chemotherapy for that malignancy
• No serious uncontrolled infection
• No serious peripheral neuropathy
• No other concurrent medical illness that would preclude study therapy
• No circumstances that would preclude study completion or follow-up
• No sensitivity to Escherichia coli-derived drug preparations
• No uterine carcinosarcoma or other non-epithelial uterine malignancy

Expected Enrollment

A total of 900 patients (450 per treatment arm) will be accrued for this study within approximately 5 years.

Outcomes

Duration of overall survival

Duration of progression-free survival

Outline

This is a randomized, multicenter study. Patients accrued as of 04/17/06 are stratified according to disease status(measurable or recurrent disease vs non-measurable stage III or IV disease with pelvic radiotherapy vs non-measurable stage III or IV disease without pelvic radiotherapy). Patients are randomized to 1 of 2 treatment arms. Patients with LVEF < 50% at randomization who are initially randomized to arm I are immediately crossed over to arm II.

• Arm I: Patients receive doxorubicin IV over 15 minutes and cisplatin IV over 60-90 minutes on day 1; paclitaxel IV over 3 hours on day 2; and filgrastim (G-CSF) subcutaneously on days 3-12.



• Arm II: Patients receive paclitaxel IV over 3 hours and carboplatin IV over 30-60 minutes on day 1.

In both arms, treatment repeats every 21 days for 7 courses in the absence of disease progression or unacceptable toxicity.

Quality of life is assessed at baseline and at weeks 6, 15, and 26 of study therapy.

Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter.

Trial Contact Information

Trial Lead Organizations

Gynecologic Oncology Group

David Miller, MD, Protocol chair		Ph: 214-648-3026; 866-460-4673 Email: david.miller@utsouthwestern.edu

Related Information

Featured trial article

Registry Information
Official Title		Randomized Phase III Trial Of Doxorubicin/Cisplatin/Paclitaxel And G-CSF Versus Carboplatin/Paclitaxel In Patients With Stage III & IV Or Recurrent Endometrial Cancer
Trial Start Date		2003-08-18
Trial Completion Date		2008-01-24 (estimated)
Registered in ClinicalTrials.gov		NCT00063999
Date Submitted to PDQ		2003-05-14
Information Last Verified		2009-04-21
NCI Grant/Contract Number		CA27469