Doxorubicin Hydrochloride, Cisplatin, and Paclitaxel or Carboplatin and Paclitaxel in Treating Patients With Stage III-IV or Recurrent Endometrial Cancer
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.
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
- To determine if the combination of carboplatin and paclitaxel (TC) chemotherapy is therapeutically equivalent to the combination of doxorubicin (doxorubicin hydrochloride), cisplatin and paclitaxel (TAP) chemotherapy with regards to survival.
II. To determine if estrogen/progesterone receptor status provides prognostic information in patients treated with chemotherapy.
III. To assess whether combination TC chemotherapy is superior to combination TAP chemotherapy with regards to toxicity profile, specifically neurotoxicity and infection.
IV. To measure differences in patient-reported neurotoxicity and quality of life (QOL) among the regimens.
OUTLINE: Patients are randomized to 1 of 2 treatment arms. Patients with left ventricular ejection fraction < 50% at randomization who are initially randomized to Arm I are immediately crossed over to Arm II.
ARM I: Patients receive doxorubicin hydrochloride intravenously (IV) over approximately 15-30 minutes on day 1, cisplatin IV over 60-90 minutes on day 1, paclitaxel IV over 3 hours on day 2, and filgrastim subcutaneously (SC) on days 3-12 or pegfilgrastim SC on day 3.
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.
After completion of study treatment, patients are followed up every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter.
Recurrent Uterine Corpus Carcinoma Stage IIIA Uterine Corpus Cancer Stage IIIB Uterine Corpus Cancer Stage IIIC Uterine Corpus Cancer Stage IVA Uterine Corpus Cancer Stage IVB Uterine Corpus Cancer Endometrial Neoplasms Uterine Neoplasms Paclitaxel Liposomal doxorubicin Albumin-Bound Paclitaxel Cisplatin Carboplatin Doxorubicin Lenograstim Doxorubicin Hydrochloride Filgrastim Laboratory Biomarker Analysis Pegfilgrastim Quality-of-Life Assessment
You can join if…
Open to females ages 18 years and up
- 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
You CAN'T join if...
- 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
- San Francisco General Hospital
San Francisco California 94110 United States
- UCSF Medical Center-Mount Zion
San Francisco California 94115 United States
- Kaiser Permanente-San Francisco
San Francisco California 94115 United States
- Kaiser Permanente-South San Francisco
South San Francisco California 94080 United States
- Marin Cancer Care Inc
Greenbrae California 94904 United States
- Kaiser Permanente-Richmond
Richmond California 94801 United States
- Kaiser Permanente-Oakland
Oakland California 94611 United States
- Kaiser Permanente San Leandro
San Leandro California 94577 United States
- Kaiser Permanente-San Rafael
San Rafael California 94903 United States
- Kaiser Permanente-Redwood City
Redwood City California 94063 United States
- Kaiser Permanente-Walnut Creek
Walnut Creek California 94596 United States
- John Muir Medical Center-Walnut Creek
Walnut Creek California 94598 United States
- John Muir Medical Center-Concord Campus
Concord California 94520 United States
- Stanford Cancer Institute
Palo Alto California 94304 United States
- Kaiser Permanente-Vallejo
Vallejo California 94589 United States
- Kaiser Permanente-Fremont
Fremont California 94538 United States
- Kaiser Permanente Medical Center - Santa Clara
Santa Clara California 95051 United States
- Community Hospital of Los Gatos
Los Gatos California 95032 United States
- Kaiser Permanente-Santa Teresa-San Jose
San Jose California 95119 United States
- Kaiser Permanente-Santa Rosa
Santa Rosa California 95403 United States
- in progress, not accepting new patients
- Start Date
- Gynecologic Oncology Group
- Phase 3
- Study Type
- Last Updated
- March 23, 2018