Treating Patients With Stage III-IV or Recurrent Endometrial Cancer

August 25, 2003
132222
Cancer-Gynecologic, Cancer
Tashanna Myers, MD
Baystate Medical Center, 759 Chestnut St, Springfield, MA
This randomized phase III trial compares how well two different combination chemotherapy regimens (doxorubicin hydrochloride, cisplatin, and paclitaxel versus carboplatin and paclitaxel) work in treating patients with endometrial cancer that is stage III-IV or has come back (recurrent). Drugs used in chemotherapy such as doxorubicin hydrochloride, cisplatin, paclitaxel, and carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. It is not yet known which combination chemotherapy regimen is more effective in treating endometrial cancer.

Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
Sexes Eligible for Study: Female
Accepts Healthy Volunteers: No

Inclusion Criteria:
• Patients must have primary stage III or stage IV or recurrent endometrial carcinoma whose potential for cure by radiation therapy or surgery alone or in combination is very poor; pathological confirmation and estrogen receptor (ER)/progesterone receptor (PR) status of the primary tumor is mandatory; however, the results do not need to be available prior to registration
• Patients may not have received prior cytotoxic chemotherapy, including chemotherapy used for radiation sensitization; patients may have received prior radiation therapy, hormonal therapy, or therapy with biologic agents, but such therapies must be discontinued prior to entry on this study
• Patients in whom both radiation and chemotherapy is planned must receive radiation prior to entry on this study; at least four weeks should have elapsed since completion of radiation therapy (RT) involving the whole pelvis or over 50% of the spine
• Platelets >= 100,000/mcl
• Granulocytes (absolute neutrophil count [ANC]) >= 1,500/mcl
• Creatinine =< upper limit of normal (ULN) (Common Toxicity Criteria [CTC] grade 0) or calculated creatinine clearance (Jeliffe Formula) >= 60 ml/min
• Serum glutamate pyruvate transaminase (SGPT) (alanine aminotransferase [ALT]) =< 3 x upper limits of normal
• Bilirubin =< institutional upper limits of normal
• Patients must have a Gynecologic Oncology Group (GOG) performance status of 0, 1, or 2
• Patients must have met the pre-entry requirements
• Patients must have signed an approved informed consent and authorization permitting release of personal health information

Exclusion Criteria:
• Patients with a concomitant malignancy other than non-melanoma skin cancer; with the exception of non-melanoma skin cancer, patients with a prior invasive malignancy who have been disease-free for < 5 years or who received prior chemotherapy for that malignancy
• Patients in whom pathological confirmation and estrogen receptor (ER)/progesterone receptor (PR) status of the tumor is not obtainable
• Patients for whom radiation therapy is planned during or after study chemotherapy prior to demonstrated progression
• Patients with concomitant medical illness such as serious uncontrolled infection, uncontrolled angina, or serious peripheral neuropathy, which, in the opinion of the treating physician, make the treatments prescribed on this study unreasonably hazardous for the patient
• Patients with third degree or complete heart block are not eligible unless a pacemaker is in place; patients on medications which alter cardiac conduction, such as digitalis, beta-blockers, or calcium channel blockers, or who have other conduction abnormalities or cardiac dysfunction may be placed on study at the discretion of the investigator
• Patients with history of myocardial infarct within 6 months before enrollment, New York Heart Association (NYHA) class II or greater heart failure or symptoms suspicious for congestive heart failure are not eligible unless a left ventricular ejection fraction in the past 6 months is documented to be 50% or greater; patients who have had a left ventricular ejection fraction (LVEF) (performed for any reason) of less than 50% in the past 6 months are ineligible
• Patients whose circumstances will not permit study completion or adequate follow-up
• Patients who are sensitive to E. coli-derived drug preparations
• Patients with uterine carcinosarcoma or other non-epithelial uterine malignancies

Active
Interventional (Clinical Trial), Randomized
3
Laura Sorci
413-794-3188