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CompletedNCT00575952Updated Aug 24, 2017

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

A Phase 1 interventional study of Cisplatin and Doxorubicin Hydrochloride in Endometrial Adenosquamous Carcinoma, Endometrial Clear Cell Adenocarcinoma and Endometrial Mixed Adenocarcinoma, sponsored by Gynecologic Oncology Group. Completed at 9 sites in United States. Open to female participants. Per ClinicalTrials.gov, last updated 2017-08-24.

Sponsored by Gynecologic Oncology Group · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
27
Allocation
Not applicable
Sex
Female
01

Study 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.

Read the 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.

02

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
03

In context

Carcinoma

6,745 studies on the registry are indexed under Carcinoma; 1,163 are open to participants now.

This study's enrollment of 27 is below the median of 45 across 5,174 interventional studies indexed under Carcinoma.

Browse Carcinoma studies →

Lead sponsor

Gynecologic Oncology Group is the lead sponsor of 181 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
Female
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
27 participants (actual)

Study arms

  • Experimental
    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.

    Drug: Cisplatin · Drug: Doxorubicin Hydrochloride · Biological: Filgrastim · Drug: Paclitaxel · Biological: Pegfilgrastim

Interventions

  • DrugCisplatin

    Given IV or IP

  • DrugDoxorubicin Hydrochloride

    Given IV

  • BiologicalFilgrastim

    Given SC

  • DrugPaclitaxel

    Given IV or IP

  • BiologicalPegfilgrastim

    Given SC

06

What researchers measure

Primary outcomes

  1. Incidence of observed DLTs, defined as grade 3-4 hematologic or non-hematologic toxicity graded using CTCAE v3.0

    Time frame: 18 weeks

  2. 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

  3. 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

07

Study locations

9 sites
  • Hartford Hospital
    Hartford, Connecticut 06102, United States
  • The Hospital of Central Connecticut
    New Britain, Connecticut 06050, United States
  • University of Chicago Comprehensive Cancer Center
    Chicago, Illinois 60637, United States
  • University of Iowa/Holden Comprehensive Cancer Center
    Iowa City, Iowa 52242, United States
  • Washington University School of Medicine
    Saint Louis, Missouri 63110, United States
  • Cooper Hospital University Medical Center
    Camden, New Jersey 08103, United States
  • Case Western Reserve University
    Cleveland, Ohio 44106, United States
  • University of Oklahoma Health Sciences Center
    Oklahoma City, Oklahoma 73104, United States
  • Women and Infants Hospital
    Providence, Rhode Island 02905, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 24, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00575952
Lead sponsor
Gynecologic Oncology Group
Collaborators
National Cancer Institute (NCI)
Responsible party
Sponsor
First posted
Dec 18, 2007
Start date
Jan 17, 2008
Primary completion
Jul 16, 2016
Completion
Jul 16, 2016
Last update
Aug 24, 2017

Study contacts

D. McMeekin
principal investigator · NRG Oncology
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2017. You cannot join it, but the record below documents what was studied.

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