Doxorubicin Hydrochloride, Cisplatin, and Paclitaxel or Carboplatin and Paclitaxel in Treating Patients With Stage III-IV or Recurrent Endometrial Cancer

Not Recruiting

Trial ID: NCT00063999


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.

Official Title

Randomized Phase III Trial of Doxorubicin/Cisplatin/Paclitaxel and G-CSF Versus Carboplatin/Paclitaxel in Patients With Stage III &Amp; IV or Recurrent Endometrial Cancer

Stanford Investigator(s)

Jonathan S. Berek, MD, MMSc
Jonathan S. Berek, MD, MMSc

Laurie Kraus Lacob Professor


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

   - 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

   - 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


biological: filgrastim

drug: carboplatin

drug: cisplatin

drug: doxorubicin hydrochloride

drug: paclitaxel

other: Laboratory Biomarker Analysis

biological: Pegfilgrastim

other: Quality-of-Life Assessment

Not Recruiting

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Maureen Sutton

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