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Phase II Trial of Paclitaxel and Carboplatin With Amifostine in Advanced Recurrent or Refractory Endometrial Adenocarcinoma

Phase 2
16 Years
Not Enrolling
Endometrial Cancer

Thank you

Trial Information

Phase II Trial of Paclitaxel and Carboplatin With Amifostine in Advanced Recurrent or Refractory Endometrial Adenocarcinoma

OBJECTIVES: I. Evaluate the efficacy of paclitaxel and carboplatin with amifostine on
progression free survival and overall survival in patients with metastatic or recurrent
epithelial endometrial carcinoma not amenable to surgery or radiotherapy. II. Evaluate
response (confirmed and unconfirmed partial response and complete response) rate to this
regimen in this patient population. III. Assess the nature and degree of toxicity of this
regimen in these patients.

OUTLINE: Patients receive paclitaxel IV over 3 hours, then amifostine IV over 10 minutes,
followed fifteen minutes later by carboplatin IV over 30-60 minutes on day 1. Courses repeat
every 28 days. Treatment continues for 6 courses in the absence of disease progression.
Patients are followed every 6 months for 2 years, then annually thereafter.

PROJECTED ACCRUAL: A total of 35 to 50 patients will be accrued for this study.

Inclusion Criteria

DISEASE CHARACTERISTICS: Histologically confirmed metastatic, recurrent, or refractory
epithelial endometrial carcinoma Must be one of the following histologic types:
Endometrioid adenocarcinoma Villoglandular Secretory Ciliated Endometrioid adenocarcinoma
with squamous differentiation Serous carcinoma Clear cell carcinoma Mucinous carcinoma
Squamous carcinoma Mixed types of carcinoma Undifferentiated carcinoma Must not be
amenable to surgery or radiotherapy Documented evidence of progression at site if the only
site of measurable disease has been irradiated Metastatic sites need not be biopsied
Measurable disease

PATIENT CHARACTERISTICS: Age: 16 and over Performance status: SWOG 0-2 Life expectancy:
Not specified Hematopoietic: Absolute granulocyte count at least 1,500/mm3 Platelet count
at least 100,000/mm3 Hepatic: Bilirubin no greater than 2 times upper limit of normal
(ULN) SGOT no greater than 2 times ULN Renal: Creatinine no greater than 2.0 mg/dL
Creatinine clearance at least 25 mL/min Other: At least 5 years since other prior
malignancy except adequately treated basal cell or squamous cell skin cancer, carcinoma in
situ of the cervix, or adequately treated stage I or II cancer in complete remission Not
pregnant or nursing Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY: Biologic therapy: No concurrent immunotherapy No more than 1
prior biologic therapy regimen Chemotherapy: No concurrent chemotherapy No prior taxane
for any reason No more than 2 prior chemotherapy courses used for the sole purpose of
radiosensitization during primary definitive therapy allowed No other prior chemotherapy
Endocrine therapy: No concurrent hormonal therapy Prior hormonal or other endocrine
therapy allowed Radiotherapy: No concurrent radiotherapy except to sites of bone
metastases for palliative control of pain Prior radiotherapy to no more than 30% of bone
marrow allowed At least 4 weeks since radiotherapy and recovered Surgery: Prior surgery
allowed Must have recovered from surgery and any complication therefrom

Type of Study:


Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Progression free survival

Outcome Description:

from date of registration to date of first observation of progressive disease, deathe due to any cause, or early discontinuation of treatment.

Outcome Time Frame:

6 months

Safety Issue:


Principal Investigator

Sidney A. Scudder, MD

Investigator Role:

Study Chair

Investigator Affiliation:

University of California, Davis


United States: Federal Government

Study ID:




Start Date:

February 1998

Completion Date:

July 2004

Related Keywords:

  • Endometrial Cancer
  • stage IV endometrial carcinoma
  • recurrent endometrial carcinoma
  • endometrial adenocarcinoma
  • endometrial adenosquamous cell carcinoma
  • endometrial clear cell carcinoma
  • Adenocarcinoma
  • Endometrial Neoplasms
  • Sarcoma, Endometrial Stromal
  • Adenoma



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University of Colorado Cancer Center Denver, Colorado  80262
Albert B. Chandler Medical Center, University of Kentucky Lexington, Kentucky  40536-0084
Barbara Ann Karmanos Cancer Institute Detroit, Michigan  48201
University of Mississippi Medical Center Jackson, Mississippi  39216-4505
Barrett Cancer Center, The University Hospital Cincinnati, Ohio  45219
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University of California Davis Medical Center Sacramento, California  95817
Tripler Army Medical Center Honolulu, Hawaii  96859-5000
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Henry Ford Hospital Detroit, Michigan  48202
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St. Louis University Health Sciences Center Saint Louis, Missouri  63110-0250
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CCOP - Dayton Kettering, Ohio  45429
CCOP - Columbia River Program Portland, Oregon  97213
CCOP - Greenville Greenville, South Carolina  29615
University of Texas Medical Branch Galveston, Texas  77555-1329
Swedish Cancer Institute Seattle, Washington  98104
MBCCOP - University of New Mexico HSC Albuquerque, New Mexico  87131
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Cancer Research Center of Hawaii Honolulu, Hawaii  96813
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University of Kansas Medical Center Kansas City, Kansas  66160-7353
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Herbert Irving Comprehensive Cancer Center New York, New York  10032
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Oklahoma Medical Research Foundation Oklahoma City, Oklahoma  73104
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Brooke Army Medical Center Fort Sam Houston, Texas  78234-6200
Texas Tech University Health Science Center Lubbock, Texas  79415
Veterans Affairs Medical Center - San Antonio (Murphy) San Antonio, Texas  78284
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CCOP - Grand Rapids Clinical Oncology Program Grand Rapids, Michigan  49503
Oregon Cancer Center at Oregon Health Sciences University Portland, Oregon  97201-3098
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Veterans Affairs Medical Center - Dallas Dallas, Texas  75216
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