Clinical trial NCT00071929: Oxaliplatin in Treating Patients With Persistent or Recurrent Endometrial Cancer
Official title: Phase II Evaluation of Oxaliplatin in the Treatment of Recurrent or Persistent Endometrial Carcinoma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Endometrial Cancer
Keywords: recurrent endometrial carcinoma
Lead sponsor: National Cancer Institute (NCI)
Sponsor class: NIH
Collaborators: name: National Cancer Institute (NCI)
First posted: 2003-11-06
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

Brief summary: RATIONALE: Drugs used in chemotherapy, such as oxaliplatin, work in different ways to stop tumor cells from dividing so they stop growing or die.

PURPOSE: Phase II trial to study the effectiveness of oxaliplatin in treating patients who have persistent or recurrent endometrial cancer.

Detailed description: 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.

Eligibility 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

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham Comprehensive Cancer Center
state: Alabama
city: Phoenix
country: United States
facility: CCOP - Western Regional, Arizona
state: Arizona
city: Orange
country: United States
facility: Chao Family Comprehensive Cancer Center at University of California Irvine Cancer Center
state: California
city: Denver
country: United States
facility: University of Colorado Cancer Center at University of Colorado Health Sciences Center
state: Colorado
city: New Britain
country: United States
facility: New Britain General Hospital
state: Connecticut
city: Newark
country: United States
facility: CCOP - Christiana Care Health Services
state: Delaware
city: Chicago
country: United States
facility: MBCCOP - University of Illinois at Chicago
state: Illinois
city: Chicago
country: United States
facility: University of Chicago Cancer Research Center
state: Illinois
city: Decatur
country: United States
facility: CCOP - Central Illinois
state: Illinois
city: Evanston
country: United States
facility: CCOP - Evanston
state: Illinois
city: Urbana
country: United States
facility: CCOP - Carle Cancer Center
state: Illinois
city: South Bend
country: United States
facility: Saint Joseph Regional Medical Center
state: Indiana
city: Kansas City
country: United States
facility: Kansas Masonic Cancer Research Institute at the University of Kansas Medical Center
state: Kansas
city: Ann Arbor
country: United States
facility: CCOP - Michigan Cancer Research Consortium
state: Michigan
city: Grand Rapids
country: United States
facility: CCOP - Grand Rapids
state: Michigan
city: Kalamazoo
country: United States
facility: CCOP - Kalamazoo
state: Michigan
city: Saint Louis Park
country: United States
facility: CCOP - Metro-Minnesota
state: Minnesota
city: Jackson
country: United States
facility: University of Mississippi Medical Center
state: Mississippi
city: Columbia
country: United States
facility: Ellis Fischel Cancer Center at University of Missouri - Columbia
state: Missouri
city: Kansas City
country: United States
facility: CCOP - Kansas City
state: Missouri
city: Springfield
country: United States
facility: CCOP - Cancer Research for the Ozarks
state: Missouri
city: Omaha
country: United States
facility: CCOP - Missouri Valley Cancer Consortium
state: Nebraska
city: Brooklyn
country: United States
facility: SUNY Downstate Medical Center
state: New York
city: Stony Brook
country: United States
facility: Long Island Cancer Center at Stony Brook University Hospital
state: New York
city: Chapel Hill
country: United States
facility: Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill
state: North Carolina
city: Cleveland
country: United States
facility: Ireland Cancer Center
state: Ohio
city: Cleveland
country: United States
facility: Cleveland Clinic Taussig Cancer Center
state: Ohio
city: Columbus
country: United States
facility: Mount Carmel West Hospital
state: Ohio
city: Oklahoma City
country: United States
facility: University of Oklahoma College of Medicine
state: Oklahoma
city: Portland
country: United States
facility: CCOP - Columbia River Oncology Program
state: Oregon
city: Abington
country: United States
facility: Abington Memorial Hospital
state: Pennsylvania
city: Danville
country: United States
facility: CCOP - Geisinger Clinic and Medical Center
state: Pennsylvania
city: Hershey
country: United States
facility: Penn State Cancer Institute at Milton S. Hershey Medical Center
state: Pennsylvania
city: Philadelphia
country: United States
facility: Fox Chase Cancer Center
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Magee-Womens Hospital
state: Pennsylvania
city: Knoxville
country: United States
facility: Southeast Gynecologic Oncology Associates
state: Tennessee
city: Nashville
country: United States
facility: Vanderbilt-Ingram Cancer Center at Vanderbilt Medical Center
state: Tennessee
city: Temple
country: United States
facility: CCOP - Scott and White Hospital
state: Texas
Study officials:
affiliation: Washington University Siteman Cancer Center
name: Paula M. Fracasso, MD, PhD
role: STUDY_CHAIR
References:
citation: Fracasso PM, Blessing JA, Molpus KL, Adler LM, Sorosky JI, Rose PG. Phase II study of oxaliplatin as second-line chemotherapy in endometrial carcinoma: a Gynecologic Oncology Group study. Gynecol Oncol. 2006 Nov;103(2):523-6. doi: 10.1016/j.ygyno.2006.03.043. Epub 2006 May 19.