Doxorubicin Hydrochloride, Cisplatin, and Paclitaxel or Carboplatin and Paclitaxel in Treating Patients With Stage III-IV or Recurrent Endometrial Cancer
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| ClinicalTrials.gov Identifier: NCT00063999 |
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Recruitment Status
:
Active, not recruiting
First Posted
: July 9, 2003
Last Update Posted
: October 28, 2016
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Sponsor:
Gynecologic Oncology Group
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Gynecologic Oncology Group
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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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| 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 | Drug: Carboplatin Drug: Cisplatin Drug: Doxorubicin Hydrochloride Biological: Filgrastim Other: Laboratory Biomarker Analysis Drug: Paclitaxel Biological: Pegfilgrastim Other: Quality-of-Life Assessment | Phase 3 |
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 (Clinical Trial) |
| Actual Enrollment : | 1331 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| 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 |
| Study Start Date : | August 2003 |
| Actual Primary Completion Date : | June 2013 |
Resource links provided by the National Library of Medicine
Drug Information available for:
Cisplatin
Doxorubicin
Doxorubicin hydrochloride
Paclitaxel
Carboplatin
U.S. FDA Resources
| Arm | Intervention/treatment |
|---|---|
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Active Comparator: Arm I (doxorubicin hydrochloride, cisplatin, paclitaxel)
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.
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Drug: Cisplatin
Given IV
Other Names:
Drug: Doxorubicin Hydrochloride
Given IV
Other Names:
Biological: Filgrastim
Given SC
Other Names:
Other: Laboratory Biomarker Analysis
Correlative studies
Drug: Paclitaxel
Given IV
Other Names:
Biological: Pegfilgrastim
Given SC
Other Names:
Other: Quality-of-Life Assessment
Ancillary studies
Other Name: Quality of Life Assessment
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Experimental: Arm II (paclitaxel, carboplatin)
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.
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Drug: Carboplatin
Given IV
Other Names:
Other: Laboratory Biomarker Analysis
Correlative studies
Drug: Paclitaxel
Given IV
Other Names:
Other: Quality-of-Life Assessment
Ancillary studies
Other Name: Quality of Life Assessment
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Primary Outcome Measures
:
- Duration of overall survival [ Time Frame: From entry into the study to death or the date of last contact, assessed up to 10 years ]A log hazard ratio with 90% confidence intervals will be used.
Secondary Outcome Measures
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- Change in functional well-being assessed using the FACT/GOG Neurotoxicity subscale [ Time Frame: Baseline to up to 26 weeks ]The difference in time-averaged total score from the subscale will be compared between treatment arms.
- Change in physical well-being assessed using the Functional Assessment of Cancer Therapy (FACT)-Endometrial subscale [ Time Frame: Baseline to up to 26 weeks ]The difference in time-averaged total score from the subscale will be compared between treatment arms.
- Duration of progression-free survival [ Time Frame: From study entry until disease progression, death, or date of last contact, assessed up to 10 years ]A logrank test or a proportional hazards model will be used to assess the equality of hazard rates between the two regimens.
- Estrogen and progesterone receptor status (positive or negative) [ Time Frame: Baseline ]This study will investigate the prognostic significance of estrogen and progesterone receptors in patients treated with combination chemotherapy. A proportional hazards model adjusted for performance status and treatment will be used to explore the relationship between receptor status and progression-free survival or survival.
- Incidence of adverse events [ Time Frame: Up to 3 weeks after completion of study treatment ]The frequency and severity of AEs was graded by CTC version 2.0, until April 1, 2010 when the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 began being utilized for AE reporting.
- Number of courses of study therapy administered (for those not completing the prescribed study therapy) [ Time Frame: Up to 21 weeks ]Will be recorded with the reason for discontinuation.
- Sites of disease and tumor grade [ Time Frame: Baseline ]The relationship between receptor status and histologic tumor grade will also be explored.
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| Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
| Sexes Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
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
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00063999
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Sponsors and Collaborators
Gynecologic Oncology Group
National Cancer Institute (NCI)
Investigators
| Principal Investigator: | David Miller | NRG Oncology |
| Responsible Party: | Gynecologic Oncology Group |
| ClinicalTrials.gov Identifier: | NCT00063999 History of Changes |
| Other Study ID Numbers: |
GOG-0209 NCI-2009-00584 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) ) CDR0000305940 GOG-0209 ( Other Identifier: NRG Oncology ) GOG-0209 ( Other Identifier: CTEP ) U10CA180868 ( U.S. NIH Grant/Contract ) U10CA027469 ( U.S. NIH Grant/Contract ) |
| First Posted: | July 9, 2003 Key Record Dates |
| Last Update Posted: | October 28, 2016 |
| Last Verified: | October 2016 |
Additional relevant MeSH terms:
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Endometrial Neoplasms Uterine Neoplasms Genital Neoplasms, Female Urogenital Neoplasms Neoplasms by Site Neoplasms Uterine Diseases Genital Diseases, Female Paclitaxel Liposomal doxorubicin Albumin-Bound Paclitaxel Cisplatin Carboplatin Doxorubicin |
Lenograstim Antineoplastic Agents, Phytogenic Antineoplastic Agents Tubulin Modulators Antimitotic Agents Mitosis Modulators Molecular Mechanisms of Pharmacological Action Antibiotics, Antineoplastic Topoisomerase II Inhibitors Topoisomerase Inhibitors Enzyme Inhibitors Adjuvants, Immunologic Immunologic Factors Physiological Effects of Drugs |