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

Primary Purpose

Endometrial Adenosquamous Carcinoma, Endometrial Clear Cell Adenocarcinoma, Endometrial Mixed Adenocarcinoma

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Cisplatin
Doxorubicin Hydrochloride
Filgrastim
Paclitaxel
Pegfilgrastim
Sponsored by
Gynecologic Oncology Group
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Endometrial Adenosquamous Carcinoma

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Sites / Locations

  • Hartford Hospital
  • The Hospital of Central Connecticut
  • University of Chicago Comprehensive Cancer Center
  • University of Iowa/Holden Comprehensive Cancer Center
  • Washington University School of Medicine
  • Cooper Hospital University Medical Center
  • Case Western Reserve University
  • University of Oklahoma Health Sciences Center
  • Women and Infants Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Treatment (doxorubicin hydrochloride, cisplatin, paclitaxel)

Arm Description

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.

Outcomes

Primary Outcome Measures

Incidence of observed DLTs, defined as grade 3-4 hematologic or non-hematologic toxicity graded using CTCAE v3.0
Maximum tolerated dose (MTD) of IP paclitaxel with fixed dose IV doxorubicin hydrochloride and IV cisplatin, determined according to dose-limiting toxicities (DLTs) graded using CTCAE v3.0
MTD of IP paclitaxel with fixed dose IV doxorubicin hydrochloride and IP cisplatin, determined according to DLTs graded using CTCAE v3.0

Secondary Outcome Measures

Full Information

First Posted
December 15, 2007
Last Updated
August 23, 2017
Sponsor
Gynecologic Oncology Group
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00575952
Brief Title
Intraperitoneal Paclitaxel, Doxorubicin Hydrochloride, and Cisplatin in Treating Patients With Stage III-IV Endometrial Cancer
Official Title
A Phase I Study of IV Doxorubicin Plus Intraperitoneal (IP) Paclitaxel and IV or IP Cisplatin in Endometrial Cancer Patients at High Risk for Peritoneal Failure
Study Type
Interventional

2. Study Status

Record Verification Date
August 2017
Overall Recruitment Status
Completed
Study Start Date
January 17, 2008 (Actual)
Primary Completion Date
July 16, 2016 (Actual)
Study Completion Date
July 16, 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Gynecologic Oncology Group
Collaborators
National Cancer Institute (NCI)

4. Oversight

5. Study Description

Brief Summary
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.
Detailed Description
PRIMARY OBJECTIVES: 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
27 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Treatment (doxorubicin hydrochloride, cisplatin, paclitaxel)
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Cisplatin
Intervention Description
Given IV or IP
Intervention Type
Drug
Intervention Name(s)
Doxorubicin Hydrochloride
Intervention Description
Given IV
Intervention Type
Biological
Intervention Name(s)
Filgrastim
Intervention Description
Given SC
Intervention Type
Drug
Intervention Name(s)
Paclitaxel
Intervention Description
Given IV or IP
Intervention Type
Biological
Intervention Name(s)
Pegfilgrastim
Intervention Description
Given SC
Primary Outcome Measure Information:
Title
Incidence of observed DLTs, defined as grade 3-4 hematologic or non-hematologic toxicity graded using CTCAE v3.0
Time Frame
18 weeks
Title
Maximum tolerated dose (MTD) of IP paclitaxel with fixed dose IV doxorubicin hydrochloride and IV cisplatin, determined according to dose-limiting toxicities (DLTs) graded using CTCAE v3.0
Time Frame
12 weeks
Title
MTD of IP paclitaxel with fixed dose IV doxorubicin hydrochloride and IP cisplatin, determined according to DLTs graded using CTCAE v3.0
Time Frame
12 weeks

10. Eligibility

Sex
Female
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
D. McMeekin
Organizational Affiliation
NRG Oncology
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hartford Hospital
City
Hartford
State/Province
Connecticut
ZIP/Postal Code
06102
Country
United States
Facility Name
The Hospital of Central Connecticut
City
New Britain
State/Province
Connecticut
ZIP/Postal Code
06050
Country
United States
Facility Name
University of Chicago Comprehensive Cancer Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States
Facility Name
University of Iowa/Holden Comprehensive Cancer Center
City
Iowa City
State/Province
Iowa
ZIP/Postal Code
52242
Country
United States
Facility Name
Washington University School of Medicine
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
Cooper Hospital University Medical Center
City
Camden
State/Province
New Jersey
ZIP/Postal Code
08103
Country
United States
Facility Name
Case Western Reserve University
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106
Country
United States
Facility Name
University of Oklahoma Health Sciences Center
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73104
Country
United States
Facility Name
Women and Infants Hospital
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02905
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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