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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
1,381
Given IV
Given IV
Given IV
Given SC
Correlative studies
Given IV
Given SC
Ancillary studies
University of Alabama at Birmingham Cancer Center
Birmingham, Alabama, United States
Clearview Cancer Institute
Huntsville, Alabama, United States
Mobile Infirmary Medical Center
Mobile, Alabama, United States
Providence Hospital
Mobile, Alabama, United States
Providence Alaska Medical Center
Anchorage, Alaska, United States
Number of Participants Alive at Time of Last Follow-up.
The time alive in months from study entry to last contact or death.
Time frame: Patients were assessed during treatment. Following completion of treatment, follow up was assessed every 3 months for 2 years, then every 6 months for 3 years and annually after for a maximum of 10 years.
Patient-reported Neurotoxicity (Ntx) as Measured by the FACT/GOG-Ntx Subscale (Short)
The FACT/GOG-Ntx subscale (short version) contains 4 items measuring sensory neuropathy. Each item is scored using a 5-point Likert scale (0=not at all; 1= a little bit; 2=somewhat; 3=quite a bit; 4=very much). For east item, reversal was performed prior to score calculation so that a large score suggests less symptom. according to the FACIT measurement system, the subscale score was calculated as the summation of the individual item scores if more than 50% of subscale items were answered. When unanswered items existed, a subscale score was prorated by multiplying the mean of the answered item scores by the number of items in the subscale. The Ntx subscale score ranges 0-16 with a large subscale score suggests less symptom or better QOL (Quality of Life).
Time frame: Baseline, 6 weeks post treatment start, 15 weeks post treatment start and 26 weeks post treatment start
Patient Reported Quality of Life as Measured With the Combination of Physical Well-being (PWB) Subscale and Functional Well-being (FWB) Subscale From the FACT-G
The FACT-G contains 4 subscales: Physical Well Being (7 items), Social Well Being (7 items), Emotional Well Being (6 items), Functional Well Being (7 items). The combination (14 items) of the physical well-being (PWB) and functional well-being (FWB) subscales was used to measure the HRQOL (Health Related Quality of Life). Each item is scored using a 5-point Likert scale (0=not at all; 1=a little bit; 2=somewhat; 3=quite a bit; 4=very much). for each negative item, reversal was performed prior to score calculation so that a large score suggests better QOL. A subscale score was calculated as the summation of the individual item scores if more than 50% of subscale items were answered. When unanswered items existed, a subscale score was prorated by multiplying the mean of the answred item scores by the number of items in the subscale. The QOL was measured with the summation of the PWB and FWBsubscale score and ranges 0-56 with a large score suggests better QOL.
Time frame: Pre-treatment, 6 weeks post starting treatment (prior to cycle 3), 15 weeks post starting treatment (prior to cycle 6), 26 weeks post starting treatment
Number of Participants Alive at Time of Last Follow-up by Estrogen or Progesterone Receptor Status (Positive or Negative)
The time alive in months from study entry to last contact or death.
Time frame: Patients were assessed during treatment. Following completion of treatment, follow up was assessed every 3 months for 2 years, then every 6 months for 3 years and annually thereafter, for a maximum of 10 years.
Number of Participants With Indicated Severity of CTCAE v2 Graded Neurotoxicity and Infection
Maximum grade of physician assessed neurotoxicity and infection
Time frame: Assessed throughout the treatment period and for 30 days after discontinuation of treatment.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Mayo Clinic in Arizona
Scottsdale, Arizona, United States
Highlands Oncology Group PA - Fayetteville
Fayetteville, Arkansas, United States
Washington Regional Medical Center - Fayetteville
Fayetteville, Arkansas, United States
University of Arkansas for Medical Sciences
Little Rock, Arkansas, United States
Providence Saint Joseph Medical Center/Disney Family Cancer Center
Burbank, California, United States
...and 640 more locations