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Eligibility
for females ages 18 years and up
Location
at San Francisco, California and other locations
Dates
study started

Description

Summary

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

Details

PRIMARY OBJECTIVES:

I. 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.

Keywords

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 Liposomal doxorubicin Cisplatin Paclitaxel Albumin-Bound Paclitaxel Carboplatin Doxorubicin Lenograstim Succinylcholine

Eligibility

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

Locations

  • 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
  • Kaiser Permanente-Stockton
    Stockton, California, 95210, United States
  • Kaiser Permanente-South Sacramento
    Sacramento, California, 95823, United States
  • University of California Davis Comprehensive Cancer Center
    Sacramento, California, 95817, United States
  • Doctors Medical Center
    Modesto, California, 95350, United States
  • Kaiser Permanente - Sacramento
    Sacramento, California, 95825, United States
  • Memorial Medical Center
    Modesto, California, 95355, United States
  • Salinas Valley Memorial
    Salinas, California, 93901, United States
  • Kaiser Permanente-Roseville
    Roseville, California, 95661, United States
  • Olive View-University of California Los Angeles Medical Center
    Sylmar, California, 91342, United States
  • Center of Hope at Renown Medical Center
    Reno, Nevada, 89502, United States
  • Renown Regional Medical Center
    Reno, Nevada, 89502, United States
  • Women's Cancer Center at Washoe
    Reno, Nevada, 89502, United States
  • Saint Mary's Regional Medical Center
    Reno, Nevada, 89503, United States
  • Providence Saint Joseph Medical Center/Disney Family Cancer Center
    Burbank, California, 91505, United States
  • Kaiser Permanente Los Angeles Medical Center
    Los Angeles, California, 90027, United States
  • Cedars-Sinai Medical Center
    Los Angeles, California, 90048, United States
  • City of Hope Comprehensive Cancer Center
    Duarte, California, 91010, United States
  • Long Beach Memorial Medical Center-Todd Cancer Institute
    Long Beach, California, 90806, United States
  • UC Irvine Health/Chao Family Comprehensive Cancer Center
    Orange, California, 92868, United States
  • University Medical Center of Southern Nevada
    Las Vegas, Nevada, 89102, United States
  • Nevada Cancer Research Foundation CCOP
    Las Vegas, Nevada, 89106, United States

Details

Status
in progress, not accepting new patients
Start Date
Sponsor
Gynecologic Oncology Group
ID
NCT00063999
Phase
Phase 3
Study Type
Interventional
Last Updated
October 1, 2016