Intraperitoneal Paclitaxel, Doxorubicin Hydrochloride, and Cisplatin in Treating Patients With Stage III-IV Endometrial Cancer
NCT ID: NCT00575952
Last Updated: 2017-08-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
27 participants
INTERVENTIONAL
2008-01-17
2016-07-16
Brief Summary
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Detailed Description
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I. To determine the maximum tolerated dose of intraperitoneal (IP) paclitaxel when given concurrently with fixed dose intravenous (IV) doxorubicin (doxorubicin hydrochloride) and IV cisplatin.
II. To determine the maximum tolerated dose of IP paclitaxel when given concurrently with fixed dose IV doxorubicin hydrochloride and IP cisplatin.
III. To determine the feasibility of an IV/IP based doxorubicin hydrochloride, paclitaxel, and cisplatin chemotherapy regimen in patients with advanced endometrial cancer.
OUTLINE: This is a dose-escalation study of paclitaxel.
Patients receive doxorubicin hydrochloride IV over 30 minutes followed by cisplatin IV over 1 hour 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. Treatment repeats every 21 days for up to 2 courses in the absence of disease progression or unacceptable toxicity.
Patients then receive doxorubicin hydrochloride IV and cisplatin IV or IP on day 1, and paclitaxel IP on days 1 or 8. Treatment repeats every 21 days for up to 4 courses in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up every 3 months for 1 year.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Treatment (doxorubicin hydrochloride, cisplatin, paclitaxel)
Patients receive doxorubicin hydrochloride IV over 30 minutes followed by cisplatin IV over 1 hour 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 up to 2 courses in the absence of disease progression or unacceptable toxicity.
Patients then receive doxorubicin hydrochloride IV and cisplatin IV or IP on day 1, and paclitaxel IP on days 1 or 8. Treatment repeats every 21 days for up to 4 courses in the absence of disease progression or unacceptable toxicity.
Cisplatin
Given IV or IP
Doxorubicin Hydrochloride
Given IV
Filgrastim
Given SC
Paclitaxel
Given IV or IP
Pegfilgrastim
Given SC
Interventions
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Cisplatin
Given IV or IP
Doxorubicin Hydrochloride
Given IV
Filgrastim
Given SC
Paclitaxel
Given IV or IP
Pegfilgrastim
Given SC
Eligibility Criteria
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Inclusion Criteria
* Patients must be optimally cytoreduced with less than or equal to 2 cm residual disease
* Absolute neutrophil count (ANC) greater than or equal to 1,500/mm\^3, equivalent to Common Toxicity Criteria (Common Terminology Criteria for Adverse Events \[CTCAE\] version 3.0 \[v3.0\]) grade 1
* Platelets greater than or equal to 100,000/mm\^3 (CTCAE v3.0 grade 0-1)
* Hemoglobin greater than or equal to 10 g/dl (CTCAE v3.0 grade 1)
* Creatinine less than or equal to 2 mg/% or 24 hour creatinine clearance \> 50 ml/min
* Bilirubin less than or equal to 1.5 x upper limit of normal (ULN) (CTCAE v3.0 grade 1)
* Serum glutamic oxaloacetic transaminase (SGOT) less than or equal to 2.5 x ULN (CTCAE v3.0 grade 1)
* Neuropathy (sensory and motor) less than or equal to CTCAE v3.0 grade 1
* Patients must have normal ejection fraction
* Patients must be enrolled within 8 weeks of surgery
* Patients who have met the pre-entry requirements
* Patients must have signed an approved informed consent and authorization permitting release of personal health information
* Patients must have a Gynecologic Oncology Group (GOG) performance status of 0, 1, or 2
Exclusion Criteria
* Patients with GOG performance grade of 3 or 4
* Patients with concomitant medical illness such as serious uncontrolled infection, uncontrolled angina, or serious peripheral neuropathy, which in the opinion of the treating physician, makes the protocol prescribed treatments hazardous to the patient
* Patients with 3rd degree or complete heart block are not eligible unless a pacemaker is in place; patients who are on medications which alter cardiac conduction (digitalis, beta blockers, calcium channel blockers) or who have other cardiac conduction abnormalities may be placed on study at the discretion of the investigator
* Patients with a history of other invasive malignancies, with the exception of non-melanoma skin cancer, are excluded if there is any evidence of other malignancy being present within the last five years; patients are also excluded if their previous cancer treatment contraindicates this protocol therapy
* Patients who have received prior radiation or chemotherapy for the cancer being treated in this study
FEMALE
No
Sponsors
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National Cancer Institute (NCI)
NIH
Gynecologic Oncology Group
NETWORK
Responsible Party
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Principal Investigators
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D. McMeekin
Role: PRINCIPAL_INVESTIGATOR
NRG Oncology
Locations
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Hartford Hospital
Hartford, Connecticut, United States
The Hospital of Central Connecticut
New Britain, Connecticut, United States
University of Chicago Comprehensive Cancer Center
Chicago, Illinois, United States
University of Iowa/Holden Comprehensive Cancer Center
Iowa City, Iowa, United States
Washington University School of Medicine
St Louis, Missouri, United States
Cooper Hospital University Medical Center
Camden, New Jersey, United States
Case Western Reserve University
Cleveland, Ohio, United States
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, United States
Women and Infants Hospital
Providence, Rhode Island, United States
Countries
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Other Identifiers
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NCI-2009-00623
Identifier Type: REGISTRY
Identifier Source: secondary_id
GOG-9920
Identifier Type: -
Identifier Source: secondary_id
CDR0000580419
Identifier Type: -
Identifier Source: secondary_id
GOG-9920
Identifier Type: OTHER
Identifier Source: secondary_id
GOG-9920
Identifier Type: OTHER
Identifier Source: secondary_id
GOG-9920
Identifier Type: -
Identifier Source: org_study_id
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