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Phase II Evaluation of Oxaliplatin in the Treatment of Recurrent or Persistent Endometrial Carcinoma


Phase 2
18 Years
N/A
Not Enrolling
Female
Endometrial Cancer

Thank you

Trial Information

Phase II Evaluation of Oxaliplatin in the Treatment of Recurrent or Persistent Endometrial Carcinoma


OBJECTIVES:

- Determine the antitumor activity of oxaliplatin in terms of response rate in patients
with persistent or recurrent endometrial carcinoma that is refractory to curative or
established therapy.

- Determine the nature and degree of toxicity of this treatment regimen in these
patients.

OUTLINE: This is a multicenter study.

Patients receive oxaliplatin IV over 2 hours on day 1. Treatment repeats every 3 weeks in
the absence of disease progression or unacceptable toxicity.

Patients are followed every 3 months for 2 years and then every 6 months for 3 years.

PROJECTED ACCRUAL: Approximately 19-51 patients will be accrued for this study.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Histologically confirmed endometrial carcinoma that is refractory to curative therapy
or established treatment

- Clinically and/or histologically confirmed persistent or recurrent disease

- Measurable disease by physical examination or medical imaging

- Sonography allowed if lesions are clearly defined on initial examination and
bidimensionally measurable

- Ascites or pleural effusions not considered measurable

- Must have received 1 prior cytotoxic therapy regimen

- May include high-dose therapy, consolidation, or extended therapy after surgical
or nonsurgical assessment

- 1 additional noncytotoxic regimen allowed

- Biologic or cytostatic agents include, but are not limited to:

- Monoclonal antibodies

- Cytokines

- Small-molecule inhibitors of signal transduction

- Ineligible for a higher priority GOG protocol

- No known brain metastases

PATIENT CHARACTERISTICS:

Age

- 18 and over

Performance status

- GOG 0-2 if received 1 prior therapy regimen

- GOG 0-1 if received 2 prior therapy regimens

Life expectancy

- Not specified

Hematopoietic

- Absolute neutrophil count at least 1,500/mm^3

- Platelet count at least 100,000/mm^3

Hepatic

- Bilirubin no greater than 1.5 times upper limit of normal (ULN)

- SGOT no greater than 2.5 times ULN

- Alkaline phosphatase no greater than 2.5 times ULN

Renal

- Creatinine no greater than 1.5 times ULN

Cardiovascular

- No symptomatic congestive heart failure, unstable angina pectoris, or cardiac
arrhythmia

Neurologic

- No sensory or motor neuropathy greater than grade 1

- No residual neuropathy attributed to prior chemotherapy or other chronic conditions
(e.g., diabetes, venous stasis, or carpal tunnel syndrome)

Other

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception

- No history of allergy to platinum compounds or antiemetics

- No active infection requiring antibiotics

- No other uncontrolled illness

- No other invasive malignancies within the past 5 years except nonmelanomatous skin
cancer

PRIOR CONCURRENT THERAPY:

Biologic therapy

- See Disease Characteristics

- At least 14 days since prior pegfilgrastim

- At least 24 hours since other prior growth factors

- At least 3 weeks since prior biologic or immunologic therapy

- No concurrent growth factors during first course of study therapy

Chemotherapy

- See Disease Characteristics

- At least 4 weeks since prior chemotherapy and recovered

- No more than 1 prior cytotoxic chemotherapy regimen, either single or combination
cytotoxic drug therapy

- No prior oxaliplatin

Endocrine therapy

- At least 1 week since prior hormonal therapy directed at tumor

- Concurrent hormone replacement therapy allowed

Radiotherapy

- At least 4 weeks since prior radiotherapy and recovered

Surgery

- Recovered from any recent surgery

Other

- At least 3 weeks since prior therapy for endometrial cancer

- No other concurrent investigational agents

- No prior anticancer therapy that would preclude study participation

Type of Study:

Interventional

Study Design:

Masking: Open Label, Primary Purpose: Treatment

Principal Investigator

Paula M. Fracasso, MD, PhD

Investigator Role:

Study Chair

Investigator Affiliation:

Washington University Siteman Cancer Center

Authority:

United States: Federal Government

Study ID:

CDR0000068235

NCT ID:

NCT00071929

Start Date:

November 1999

Completion Date:

September 2007

Related Keywords:

  • Endometrial Cancer
  • recurrent endometrial carcinoma
  • Endometrial Neoplasms
  • Sarcoma, Endometrial Stromal
  • Adenoma

Name

Location

University of Chicago Cancer Research CenterChicago, Illinois  60637
University of Mississippi Medical CenterJackson, Mississippi  39216-4505
Ireland Cancer CenterCleveland, Ohio  44106-5065
University of Oklahoma College of MedicineOklahoma City, Oklahoma  73190
Abington Memorial HospitalAbington, Pennsylvania  19001
Fox Chase Cancer CenterPhiladelphia, Pennsylvania  19111
CCOP - Kansas CityKansas City, Missouri  64131
CCOP - Missouri Valley Cancer ConsortiumOmaha, Nebraska  68131
CCOP - Christiana Care Health ServicesWilmington, Delaware  19899
CCOP - Carle Cancer CenterUrbana, Illinois  61801
CCOP - KalamazooKalamazoo, Michigan  49007-3731
CCOP - Metro-MinnesotaSaint Louis Park, Minnesota  55416
CCOP - Michigan Cancer Research ConsortiumAnn Arbor, Michigan  48106
Penn State Cancer Institute at Milton S. Hershey Medical CenterHershey, Pennsylvania  17033-0850
University of Alabama at Birmingham Comprehensive Cancer CenterBirmingham, Alabama  35294-3300
CCOP - Central IllinoisSpringfield, Illinois  62526
CCOP - Cancer Research for the OzarksSpringfield, Missouri  65807
CCOP - Western Regional, ArizonaPhoenix, Arizona  85006-2726
Chao Family Comprehensive Cancer Center at University of California Irvine Cancer CenterOrange, California  92868
University of Colorado Cancer Center at University of Colorado Health Sciences CenterDenver, Colorado  80010
MBCCOP - University of Illinois at ChicagoChicago, Illinois  60612
CCOP - EvanstonEvanston, Illinois  60201
Saint Joseph Regional Medical CenterSouth Bend, Indiana  46617
CCOP - Grand RapidsGrand Rapids, Michigan  49503
Ellis Fischel Cancer Center at University of Missouri - ColumbiaColumbia, Missouri  65203
Long Island Cancer Center at Stony Brook University HospitalStony Brook, New York  11790-7775
Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel HillChapel Hill, North Carolina  27599-7570
CCOP - Columbia River Oncology ProgramPortland, Oregon  97225
CCOP - Geisinger Clinic and Medical CenterDanville, Pennsylvania  17822-2001
Southeast Gynecologic Oncology AssociatesKnoxville, Tennessee  37917
Vanderbilt-Ingram Cancer Center at Vanderbilt Medical CenterNashville, Tennessee  37232-2516
CCOP - Scott and White HospitalTemple, Texas  76508
Cleveland Clinic Taussig Cancer CenterCleveland, Ohio  44195
Kansas Masonic Cancer Research Institute at the University of Kansas Medical CenterKansas City, Kansas  66160-7353
SUNY Downstate Medical CenterBrooklyn, New York  11203
New Britain General HospitalNew Britain, Connecticut  06050
Mount Carmel West HospitalColumbus, Ohio  43222
Magee-Womens HospitalPittsburgh, Pennsylvania  15213-3180