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

Completed · Phase 1

Conditions studied: Endometrial Adenosquamous Carcinoma, Endometrial Clear Cell Adenocarcinoma, Endometrial Mixed Adenocarcinoma, Endometrial Serous Adenocarcinoma, Endometrial Squamous Cell Carcinoma, Endometrial Undifferentiated Carcinoma, Recurrent Uterine Corpus Carcinoma, Stage IIIA Uterine Corpus Cancer, Stage IIIC Uterine Corpus Cancer, Stage IVA Uterine Corpus Cancer, Stage IVB Uterine Corpus Cancer

In brief

This phase I trial studies the side effects and best dose of intraperitoneal paclitaxel when given together with doxorubicin hydrochloride and cisplatin in treating patients with stage III-IV endometrial cancer. Drugs used in chemotherapy, such as paclitaxel, doxorubicin hydrochloride, and cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) and giving them in different ways may kill more tumor cells.

Key facts

Study ID

NCT00575952

Run by

Gynecologic Oncology Group

People needed

27

Starts

2008-01-17

Expected to finish

2016-07-16

Last updated by the study team

2017-08-24

Who can join

Age: any. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• Patients with stage IIIA, or stage IIIC with positive cytologic washings/ascites, adnexal spread, or serosal involvement, or stage IV (by virtue of intraperitoneal disease spread) histologically confirmed endometrial cancer (endometrioid, serous, clear cell, squamous/adenosquamous, undifferentiated, or mixed histologies)
• 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

You may not qualify if…

• Metastatic disease involving lung or liver parenchyma, bone or inguinal or scalene lymph nodes
• 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

Where it is running

• 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

Full record on ClinicalTrials.gov

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