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Combination Chemotherapy in Treating Patients With Stage III, Stage IV, or Recurrent Endometrial Cancer
This study is currently recruiting participants.
Verified by University of Medicine and Dentistry New Jersey, June 2008
First Received: June 12, 2008   Last Updated: June 16, 2008   History of Changes
Sponsors and Collaborators: University of Medicine and Dentistry New Jersey
Gynecologic Oncology Group
National Cancer Institute (NCI)
Information provided by: University of Medicine and Dentistry New Jersey
ClinicalTrials.gov Identifier: NCT00698620
  Purpose

This study is being done on women who have cancer of the endometrium (lining of the womb), that cannot be cured with surgery or radiation therapy. In a previous study, women with an advanced stage of endometrium cancer showed improved chances of survival after receiving chemotherapy. In advanced or recurrent endometrial cancer, the Gynecologic Oncology Group (GOG) has used chemotherapy with the drugs cisplatin, doxorubicin and paclitaxel to treat these patients. Additionally, other doctors have used the drugs carboplatin and paclitaxel to treat similar patients. Both of these treatments have been shown to shrink tumors in patients with endometrial cancer.

The purpose of this study is to find out whether treatment with the two-drug combination of carboplatin and paclitaxel is as good as the current standard three-drug combination of cisplatin, doxorubicin, and paclitaxel. Side effect information will also be analyzed to see if there are any differences between the two-drug and three-drug chemotherapy combinations with regard to ease of treatment and patient tolerance. Lastly, there are no known treatments for endometrial cancer that have been shown to be better than these two chemotherapy regimens.


Condition Intervention Phase
Endometrial Cancer
Drug: paclitaxel
Drug: doxorubicin
Drug: cisplatin
Drug: filgrastim
Phase III

MedlinePlus related topics: Cancer
Drug Information available for: Cisplatin Doxorubicin Doxorubicin hydrochloride Paclitaxel Myocet Filgrastim Granulocyte colony-stimulating factor
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Open Label, Active Control, Crossover Assignment, Efficacy Study
Official Title: Randomized Phase III Trial Of Doxorubicin/Cisplatin/Paclitaxel And G-CSF Versus Carboplatin/Paclitaxel In Patients With Stage III & IV Or Recurrent Endometrial Cancer

Further study details as provided by University of Medicine and Dentistry New Jersey:

Primary Outcome Measures:
  • Duration of overall survival [ Time Frame: Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Duration of progression-free survival [ Time Frame: Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter. ] [ Designated as safety issue: No ]

Estimated Enrollment: 900
Study Start Date: August 2003
Estimated Primary Completion Date: January 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
I: Active Comparator
Patients receive doxorubicin IV over 15 minutes and cisplatin IV over 60-90 minutes on day 1; paclitaxel IV over 3 hours on day 2; and filgrastim (G-CSF) subcutaneously on days 3-12. Treatment repeats every 21 days for 7 courses in the absence of disease progression or unacceptable toxicity.
Drug: paclitaxel
paclitaxel IV over 3 hours on day 1. Treatment repeats every 21 days for 7 courses in the absence of disease progression or unacceptable toxicity.
Drug: doxorubicin
Patients receive doxorubicin IV over 15 minutes on day 1
Drug: cisplatin
cisplatin IV over 60-90 minutes on day 1
Drug: filgrastim
filgrastim (G-CSF) subcutaneously on days 3-12
II: Active Comparator
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.
Drug: paclitaxel
paclitaxel IV over 3 hours on day 1. Treatment repeats every 21 days for 7 courses in the absence of disease progression or unacceptable toxicity.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Histologically confirmed endometrial carcinoma

    • FIGO stage III or IV or recurrent disease
  • Must know estrogen and progesterone status of the primary tumor
  • Poor potential for curative treatment by radiotherapy and/or surgery
  • At least 1 unidimensionally measurable lesion (for patients with stage III disease only)

    • At least 20 mm by conventional techniques (e.g., palpation, plain x-ray, CT scan, or MRI) OR at least 10 mm by spiral CT scan
    • Disease in a previously irradiated field acceptable as the only site of measurable disease only if there has been clear progression since completion of radiotherapy

PATIENT CHARACTERISTICS:

AGE

  • 18 and over PERFORMANCE STATUS
  • GOG 0-2 LIFE EXPECTANCY
  • Not specified HEMATOPOIETIC
  • Absolute neutrophil count at least 1,500/mm^3
  • Platelet count at least 100,000/mm^3 HEPATIC
  • Bilirubin normal
  • ALT no greater than 3 times upper limit of normal RENAL
  • Creatinine no greater than 1.6 mg/dL CARDIOVASCULAR
  • LVEF at least 50%
  • Cardiac conduction abnormalities or dysfunction allowed at the investigator's discretion
  • No third-degree or complete heart block without a pacemaker
  • No uncontrolled angina
  • No myocardial infarction within the past 6 months
  • No New York Heart Association class II -IV heart failure
  • No symptoms of congestive heart failure OTHER
  • Not pregnant or nursing
  • Fertile patients must use effective non-hormonal contraception during and for at least 2 months after study participation
  • No other invasive malignancy within the past 5 years except patients who have nonmelanoma skin cancer or have received prior chemotherapy for that malignancy
  • No serious uncontrolled infection
  • No serious peripheral neuropathy
  • No other concurrent medical illness that would preclude study therapy
  • No circumstances that would preclude study completion or follow-up
  • No sensitivity to Escherichia coli-derived drug preparations
  • No uterine carcinosarcoma or other non-epithelial uterine malignancy

PRIOR CONCURRENT THERAPY:

BIOLOGIC THERAPY

  • Prior biologic therapy allowed
  • No concurrent biologic therapy CHEMOTHERAPY
  • No prior cytotoxic chemotherapy (including radiotherapy sensitization) for this or any other malignancy ENDOCRINE THERAPY
  • Prior hormonal therapy allowed
  • No concurrent hormonal therapy RADIOTHERAPY
  • See Disease Characteristics
  • At least 4 weeks since prior radiotherapy to the whole pelvis or over 50% of the spine
  • No concurrent radiotherapy SURGERY
  • Not specified OTHER
  • Concurrent medications that alter cardiac conduction (e.g., digitalis, beta blockers, or calcium channel blockers) are allowed at the investigator's discretion
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00698620

Contacts
Contact: Bernadette Cracchiolo, MD, MPH 973-972-5055 cracchbm@umdnj.edu
Contact: Yasmeen S Barber, BA 9739727789 barberys@umdnj.edu

Locations
United States, New Jersey
University of Medicine and Dentistry of New Jersey Recruiting
Newark, New Jersey, United States, 07101
Contact: Yasmeen S Barber, BA     973-972-7789     barberys@umdnj.edu    
Principal Investigator: Baernadette Cracchiolo, MD, MPH            
Sub-Investigator: Debra Heller, MD            
Sub-Investigator: Margarette Bryan, MD            
Sponsors and Collaborators
University of Medicine and Dentistry New Jersey
Gynecologic Oncology Group
Investigators
Study Chair: David S. Miller, MD Simmons Cancer Center
  More Information

No publications provided

Responsible Party: Gynecologic Oncology Group ( DAVID SCOTT MILLER, M.D. Study Chair )
Study ID Numbers: 0120040379
Study First Received: June 12, 2008
Last Updated: June 16, 2008
ClinicalTrials.gov Identifier: NCT00698620     History of Changes
Health Authority: United States: Institutional Review Board

Study placed in the following topic categories:
Genital Neoplasms, Female
Uterine Diseases
Urogenital Neoplasms
Endometrial Cancer
Antimitotic Agents
Carboplatin
Recurrence
Doxorubicin
Genital Diseases, Female
Anti-Bacterial Agents
Endometrial Neoplasms
Cisplatin
Radiation-Sensitizing Agents
Paclitaxel
Tubulin Modulators
Uterine Neoplasms
Antineoplastic Agents, Phytogenic

Additional relevant MeSH terms:
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Mitosis Modulators
Physiological Effects of Drugs
Genital Neoplasms, Female
Uterine Diseases
Urogenital Neoplasms
Antimitotic Agents
Antibiotics, Antineoplastic
Pharmacologic Actions
Doxorubicin
Genital Diseases, Female
Endometrial Neoplasms
Neoplasms
Neoplasms by Site
Radiation-Sensitizing Agents
Cisplatin
Paclitaxel
Therapeutic Uses
Tubulin Modulators
Uterine Neoplasms
Antineoplastic Agents, Phytogenic

ClinicalTrials.gov processed this record on May 07, 2009