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NCT00063999 · CITED IN SOURCE DOCUMENTS

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

An NCI or FDA source cites this study. A citation does not establish that it applies to an individual diagnosis.

Phase
PHASE3
Status at capture
COMPLETED
Registry last update
2021-10-19

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.

Open the original ClinicalTrials.gov record → · Download preserved record

What did the study report?

Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.

flow

Participant flow

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baseline

Baseline characteristics

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outcome · POSTED

Number of Participants Alive at Time of Last Follow-up.

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outcome · POSTED

Patient-reported Neurotoxicity (Ntx) as Measured by the FACT/GOG-Ntx Subscale (Short)

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outcome · POSTED

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

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outcome · POSTED

Number of Participants Alive at Time of Last Follow-up by Estrogen or Progesterone Receptor Status (Positive or Negative)

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outcome · POSTED

Number of Participants With Indicated Severity of CTCAE v2 Graded Neurotoxicity and Infection

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adverse events

Adverse events

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more info

Limitations, agreements, and source contact

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Who could take part
eligibility Criteria
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
healthy Volunteers
false
minimum Age
18 Years
sex
FEMALE
std Ages
  1. ADULT
  2. OLDER_ADULT
Treatment arms and interventions
arm Groups
  1. description
    Patients receive doxorubicin hydrochloride 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 SC on days 3-12 or pegfilgrastim SC on day 3. Treatment repeats every 21 days for 7 courses in the absence of disease progression or unacceptable toxicity.
    intervention Names
    1. Drug: Cisplatin
    2. Drug: Doxorubicin Hydrochloride
    3. Biological: Filgrastim
    4. Other: Laboratory Biomarker Analysis
    5. Drug: Paclitaxel
    6. Biological: Pegfilgrastim
    7. Other: Quality-of-Life Assessment
    label
    Arm I (doxorubicin hydrochloride, cisplatin, paclitaxel)
    type
    ACTIVE_COMPARATOR
  2. description
    Patients receive paclitaxel IV over 3 hours and carboplatin IV over 30-60 minutes on day 1. Treatment repeats every 21 days for 7 courses in the absence of disease progression or unacceptable toxicity.
    intervention Names
    1. Drug: Carboplatin
    2. Other: Laboratory Biomarker Analysis
    3. Drug: Paclitaxel
    4. Other: Quality-of-Life Assessment
    label
    Arm II (paclitaxel, carboplatin)
    type
    EXPERIMENTAL
interventions
  1. arm Group Labels
    1. Arm II (paclitaxel, carboplatin)
    description
    Given IV
    name
    Carboplatin
    other Names
    1. Blastocarb
    2. Carboplat
    3. Carboplatin Hexal
    4. Carboplatino
    5. Carbosin
    6. Carbosol
    7. Carbotec
    8. CBDCA
    9. Displata
    10. Ercar
    11. JM-8
    12. Nealorin
    type
    DRUG
  2. arm Group Labels
    1. Arm I (doxorubicin hydrochloride, cisplatin, paclitaxel)
    description
    Given IV
    name
    Cisplatin
    other Names
    1. Abiplatin
    2. Blastolem
    3. Briplatin
    4. CDDP
    5. Cis-diammine-dichloroplatinum
    6. Cis-diamminedichloridoplatinum
    7. Cis-diamminedichloro Platinum (II)
    8. Cis-diamminedichloroplatinum
    9. Cis-dichloroammine Platinum (II)
    10. Cis-platinous Diamine Dichloride
    11. Cis-platinum
    12. Cis-platinum II
    type
    DRUG
  3. arm Group Labels
    1. Arm I (doxorubicin hydrochloride, cisplatin, paclitaxel)
    description
    Given IV
    name
    Doxorubicin Hydrochloride
    other Names
    1. 5,12-Naphthacenedione, 10-[(3-amino-2,3,6-trideoxy-alpha-L-lyxo-hexopyranosyl)oxy]-7,8, 9,10-tetrahydro-6,8,11-trihydroxy-8-(hydroxyacetyl)-1-methoxy-, hydrochloride, (8S-cis)- (9CI)
    2. ADM
    3. Adriacin
    4. Adriamycin
    5. Adriamycin Hydrochloride
    6. Adriamycin PFS
    7. Adriamycin RDF
    8. ADRIAMYCIN, HYDROCHLORIDE
    9. Adriamycine
    10. Adriblastina
    11. Adriblastine
    12. Adrimedac
    type
    DRUG
  4. arm Group Labels
    1. Arm I (doxorubicin hydrochloride, cisplatin, paclitaxel)
    description
    Given SC
    name
    Filgrastim
    other Names
    1. FILGRASTIM, LICENSE HOLDER UNSPECIFIED
    2. G-CSF
    3. Neupogen
    4. r-metHuG-CSF
    5. Recombinant Methionyl Human Granulocyte Colony Stimulating Factor
    6. rG-CSF
    7. Tevagrastim
    type
    BIOLOGICAL
  5. arm Group Labels
    1. Arm I (doxorubicin hydrochloride, cisplatin, paclitaxel)
    2. Arm II (paclitaxel, carboplatin)
    description
    Correlative studies
    name
    Laboratory Biomarker Analysis
    type
    OTHER
  6. arm Group Labels
    1. Arm I (doxorubicin hydrochloride, cisplatin, paclitaxel)
    2. Arm II (paclitaxel, carboplatin)
    description
    Given IV
    name
    Paclitaxel
    other Names
    1. Anzatax
    2. Asotax
    3. Bristaxol
    4. Praxel
    5. Taxol
    6. Taxol Konzentrat
    type
    DRUG
  7. arm Group Labels
    1. Arm I (doxorubicin hydrochloride, cisplatin, paclitaxel)
    description
    Given SC
    name
    Pegfilgrastim
    other Names
    1. Filgrastim SD-01
    2. filgrastim-SD/01
    3. Fulphila
    4. HSP-130
    5. Jinyouli
    6. Neulasta
    7. Neulastim
    8. Pegfilgrastim Biosimilar HSP-130
    9. SD-01
    10. SD-01 sustained duration G-CSF
    type
    BIOLOGICAL
  8. arm Group Labels
    1. Arm I (doxorubicin hydrochloride, cisplatin, paclitaxel)
    2. Arm II (paclitaxel, carboplatin)
    description
    Ancillary studies
    name
    Quality-of-Life Assessment
    other Names
    1. Quality of Life Assessment
    type
    OTHER
Study design
allocation
RANDOMIZED
intervention Model
PARALLEL
masking Info
masking
NONE
primary Purpose
TREATMENT
Enrollment
count
1381
type
ACTUAL
Registered outcome plans (not posted results)
primary Outcomes
  1. description
    The time alive in months from study entry to last contact or death.
    measure
    Number of Participants Alive at Time of Last Follow-up.
    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.
secondary Outcomes
  1. description
    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).
    measure
    Patient-reported Neurotoxicity (Ntx) as Measured by the FACT/GOG-Ntx Subscale (Short)
    time Frame
    Baseline, 6 weeks post treatment start, 15 weeks post treatment start and 26 weeks post treatment start
  2. description
    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.
    measure
    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
    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
  3. description
    The time alive in months from study entry to last contact or death.
    measure
    Number of Participants Alive at Time of Last Follow-up by Estrogen or Progesterone Receptor Status (Positive or Negative)
    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.
  4. description
    Maximum grade of physician assessed neurotoxicity and infection
    measure
    Number of Participants With Indicated Severity of CTCAE v2 Graded Neurotoxicity and Infection
    time Frame
    Assessed throughout the treatment period and for 30 days after discontinuation of treatment.
Full study description
brief 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.
detailed Description
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.
Source references
references
  1. citation
    Miller DS, Filiaci VL, Mannel RS, Cohn DE, Matsumoto T, Tewari KS, DiSilvestro P, Pearl ML, Argenta PA, Powell MA, Zweizig SL, Warshal DP, Hanjani P, Carney ME, Huang H, Cella D, Zaino R, Fleming GF. Carboplatin and Paclitaxel for Advanced Endometrial Cancer: Final Overall Survival and Adverse Event Analysis of a Phase III Trial (NRG Oncology/GOG0209). J Clin Oncol. 2020 Nov 20;38(33):3841-3850. doi: 10.1200/JCO.20.01076. Epub 2020 Sep 29.
    pmid
    33078978
    type
    DERIVED
Source notices and limitations
    Discovery and provenance
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      occurrences
      1. context exact
        nd measurable disease either after primary surgery or at recurrence.</p></li><li>The phase III, randomized, open-label, noninferiority <a href="/clinicaltrials/NCT00063999">GOG-0209</a> trial (NCT000063999) compared the combination of paclitaxel, doxorubicin, cisplatin (TAP), and G-CSF with carboplatin and paclitaxel (TC) in 1,3
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      source title
      Endometrial Cancer Treatment (PDQ®)–Health Professional Version
      source update dates
      1. context
        Updated: May 14, 2025
        datetime
        2025-05-14T12:00:00Z
        display
        May 14, 2025

    Preserved source evidence · Not medical advice