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Ovarian CancerPhase 2NCT00005836

Oxaliplatin in Treating Patients With Recurrent or Refractory Ovarian Epithelial Cancer or Primary Peritoneal Cancer That Has Not Responded to Platinum- Based Chemotherapy

A Phase 2 study testing oxaliplatin in people with Ovarian Cancer and Primary Peritoneal Cavity Cancer, run by Gynecologic Oncology Group at 74 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

RATIONALE: Drugs used in chemotherapy use 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 recurrent or refractory ovarian epithelial cancer or primary peritoneal cancer that has not responded… Read more about this study

Who is it for?
Any age, women only
What is being tested?
oxaliplatin
How many people
Not given
Where
74 sitesin 2 countries
Study dates
Feb 2000to Jul 2004
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • Women only
  • No healthy volunteers
  • Child, Adult, Older adult

DISEASE CHARACTERISTICS: Histologically confirmed recurrent or refractory ovarian epithelial or primary peritoneal carcinoma Bidimensionally measurable disease Ascites and pleural effusions are not considered measurable disease Sonography acceptable provided lesions are clearly defined on initial examination and bidimensionally measurable Must have had 1 prior platinum based chemotherapy regimen containing carboplatin, cisplatin, or another organoplatinum compound for management of primary disease Initial treatment may include high dose therapy, consolidation, or extended therapy administered after surgical or nonsurgical assessment No additional cytotoxic chemotherapy for management of recurrent or persistent disease, including retreatment with initial chemotherapy regimens Must be considered platinum resistant or refractory Treatment free interval of less than 6 months following platinum or progression during platinum based therapy No known brain metastases Must not be eligible for a higher priority GOG protocol

PATIENT CHARACTERISTICS: Age: Not specified Performance status: GOG 0-2 Life expectancy: Not specified Hematopoietic: Absolute neutrophil count at least 1,500/mm3 Platelet count at least lower limit of normal 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 No unstable angina pectoris No cardiac arrhythmia Other: Not pregnant or nursing Fertile patients must use effective contraception No active infection requiring antibiotics No evidence of preexisting peripheral sensory neuropathy greater than grade 1, including residual neuropathy attributed to prior chemotherapy and other chronic conditions (e.g., diabetes, venous stasis, and carpal tunnel syndrome) No history of allergy to platinum compounds or to antiemetics appropriate for administration in conjunction with protocol directed chemotherapy No other uncontrolled concurrent illness (e.g., ongoing or active infection) No other malignancy within the past 5 years except nonmelanoma skin cancer and no other prior malignancy whose prior cancer treatment contraindicates this protocol therapy

PRIOR CONCURRENT THERAPY: Biologic therapy: At least 3 weeks since prior biologic therapy At least 3 weeks since prior immunotherapy No concurrent colony stimulating factors (CSFs) during first course of therapy At least 24 hours since prior CSFs during subsequent courses of therapy Chemotherapy: See Disease Characteristics No prior oxaliplatin No more than 1 prior chemotherapy regimen If initial therapy did not include paclitaxel, a second regimen including paclitaxel is allowed At least 3 weeks since prior chemotherapy and recovered Endocrine therapy: At least 1 week since prior hormonal therapy directed at malignant tumor Concurrent continuation of hormone replacement therapy allowed Radiotherapy: At least 3 weeks since prior radiotherapy and recovered No prior radiotherapy to sites of measurable disease used on this trial No prior radiotherapy to greater than 25% of bone marrow Surgery: At least 3 weeks since prior surgery and recovered Other: No other concurrent investigational agents No concurrent antiretroviral therapy (HAART)

Trial locations and contacts

74 sites in 2 countries.

74 sites in 2 countries

United States73 sites

  • Abington Memorial Hospital

    Abington, Pennsylvania, 19001

  • Cancer Center of Albany Medical Center

    Albany, New York, 12208

  • CCOP - Ann Arbor Regional

    Ann Arbor, Michigan, 48106

  • Emory University Hospital - Atlanta

    Atlanta, Georgia, 30322

  • Johns Hopkins Oncology Center

    Baltimore, Maryland, 21287

  • Medicine Branch

    Bethesda, Maryland, 20892

  • Radiation Oncology Branch

    Bethesda, Maryland, 20892

  • CCOP - Montana Cancer Consortium

    Billings, Montana, 59101

  • University of Alabama Comprehensive Cancer Center

    Birmingham, Alabama, 35294

  • Tufts University School of Medicine

    Boston, Massachusetts, 02111

  • State University of New York Health Science Center at Brooklyn

    Brooklyn, New York, 11203

  • Cooper Hospital/University Medical Center

    Camden, New Jersey, 08103

  • Lineberger Comprehensive Cancer Center, UNC

    Chapel Hill, North Carolina, 27599-7295

  • Medical University of South Carolina

    Charleston, South Carolina, 29425-0721

  • Cancer Center, University of Virginia HSC

    Charlottesville, Virginia, 22908

  • MBCCOP - University of Illinois at Chicago

    Chicago, Illinois, 60612-7323

  • Rush-Presbyterian-St. Luke's Medical Center

    Chicago, Illinois, 60612

  • University of Chicago Cancer Research Center

    Chicago, Illinois, 60637

  • Barrett Cancer Center, The University Hospital

    Cincinnati, Ohio, 45219

  • Ireland Cancer Center

    Cleveland, Ohio, 44106-5065

  • Cleveland Clinic Cancer Center

    Cleveland, Ohio, 44195

  • Ellis Fischel Cancer Center

    Columbia, Missouri, 65203

  • Arthur G. James Cancer Hospital - Ohio State University

    Columbus, Ohio, 43210

  • Simmons Cancer Center - Dallas

    Dallas, Texas, 75235-9154

  • University of Colorado Cancer Center

    Denver, Colorado, 80262

  • CCOP - Iowa Oncology Research Association

    Des Moines, Iowa, 10309-1016

  • Barbara Ann Karmanos Cancer Institute

    Detroit, Michigan, 48201

  • Duke Comprehensive Cancer Center

    Durham, North Carolina, 27710

  • CCOP - Evanston

    Evanston, Illinois, 60201

  • CCOP - Greenville

    Greenville, South Carolina, 29615

  • Milton S. Hershey Medical Center

    Hershey, Pennsylvania, 17033

  • MBCCOP - Hawaii

    Honolulu, Hawaii, 96813

  • University of Texas - MD Anderson Cancer Center

    Houston, Texas, 77030

  • Indiana University Cancer Center

    Indianapolis, Indiana, 46202-5265

  • University of Iowa Hospitals and Clinics

    Iowa City, Iowa, 52242

  • University of Mississippi Medical Center

    Jackson, Mississippi, 39216-4505

  • CCOP - Kansas City

    Kansas City, Missouri, 64131

  • Keesler Medical Center - Keesler AFB

    Keesler Air Force Base, Mississippi, 39534-2576

  • CCOP - Southern Nevada Cancer Research Foundation

    Las Vegas, Nevada, 89106

  • Albert B. Chandler Medical Center, University of Kentucky

    Lexington, Kentucky, 40536-0084

  • USC/Norris Comprehensive Cancer Center

    Los Angeles, California, 90033-0800

  • Jonsson Comprehensive Cancer Center, UCLA

    Los Angeles, California, 90095-1781

  • North Shore University Hospital

    Manhasset, New York, 11030

  • CCOP - Baptist Cancer Institute

    Memphis, Tennessee, 38117

  • University of Minnesota Cancer Center

    Minneapolis, Minnesota, 55455

  • Memorial Sloan-Kettering Cancer Center

    New York, New York, 10021

  • University of Oklahoma College of Medicine

    Oklahoma City, Oklahoma, 73190

  • CCOP - Missouri Valley Cancer Consortium

    Omaha, Nebraska, 68131

  • Chao Family Comprehensive Cancer Center

    Orange, California, 92868

  • Women's Cancer Center

    Palo Alto, California, 94304

  • University of Pennsylvania Cancer Center

    Philadelphia, Pennsylvania, 19104

  • Kimmel Cancer Center of Thomas Jefferson University - Philadelphia

    Philadelphia, Pennsylvania, 19107

  • Pennsylvania Hospital

    Philadelphia, Pennsylvania, 19107

  • Fox Chase Cancer Center

    Philadelphia, Pennsylvania, 19111

  • CCOP - Greater Phoenix

    Phoenix, Arizona, 85006-2726

  • CCOP - Columbia River Program

    Portland, Oregon, 97213

  • University of Rochester Cancer Center

    Rochester, New York, 14642

  • University of Washington Medical Center

    Seattle, Washington, 98195-6043

  • CCOP - Upstate Carolina

    Spartanburg, South Carolina, 29303

  • CCOP - Central Illinois

    Springfield, Illinois, 62526

  • CCOP - Cancer Research for the Ozarks

    Springfield, Missouri, 65807

  • Washington University School of Medicine

    St Louis, Missouri, 63110

  • State University of New York Health Sciences Center - Stony Brook

    Stony Brook, New York, 11790-9832

  • Tacoma General Hospital

    Tacoma, Washington, 98405

  • H. Lee Moffitt Cancer Center and Research Institute

    Tampa, Florida, 33612

  • CCOP - Scott and White Hospital

    Temple, Texas, 76508

  • CCOP - St. Francis Hospital/Natalie Warren Bryant Cancer Center

    Tulsa, Oklahoma, 74136

  • Vincent T. Lombardi Cancer Research Center, Georgetown University

    Washington D.C., District of Columbia, 20007

  • Walter Reed Army Medical Center

    Washington D.C., District of Columbia, 20307-5000

  • Brookview Research, Inc.

    Winston-Salem, North Carolina, 27103

  • Comprehensive Cancer Center of Wake Forest University Baptist Medical Center

    Winston-Salem, North Carolina, 27157-1082

  • University of Massachusetts Memorial Medical Center

    Worcester, Massachusetts, 01655

  • CCOP - MainLine Health

    Wynnewood, Pennsylvania, 19096

Other trials in United States

Canada1 site

  • NCIC-Clinical Trials Group

    Kingston, Ontario, K7L 3N6

Other trials in Canada

About this study

Official title: Phase II Evaluation of Oxaliplatin in Recurrent, Platinum Resistant and Refractory Ovarian Cancer

RATIONALE: Drugs used in chemotherapy use 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 recurrent or refractory ovarian epithelial cancer or primary peritoneal cancer that has not responded to platinum-based chemotherapy.

Read the detailed description

OBJECTIVES: I. Determine the antitumor activity of oxaliplatin by measuring response rate in patients with recurrent or refractory, platinum resistant ovarian epithelial or primary peritoneal carcinoma who have failed on higher priority treatment protocols. II. Determine the nature and degree of toxicity of this drug in this patient population.

OUTLINE: Patients receive oxaliplatin IV over 2 hours. Treatment continues every 21 days for a maximum of 9 courses in the absence of unacceptable toxicity or disease progression. Patients are followed every 3 months for 2 years and then every 6 months for 3 years.

PROJECTED ACCRUAL: A total of 22-60 patients will be accrued for this study within 12-14 months.

Being tested
oxaliplatin
Keywords
recurrent ovarian epithelial cancer, primary peritoneal cavity cancer
Medical subject headings
Ovarian Neoplasms, Carcinoma, Ovarian Epithelial

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Apr 2003 (estimated)
  2. Study startFeb 2000
  3. Study completionJul 2004

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
IDs, dates and publications
ClinicalTrials.gov ID
NCT00005836
Sponsor's protocol ID
CDR0000067851
Other IDs
GOG-126K
Status last verified
Mar 2003
First submitted
2 Jun 2000
Last updated
21 Jun 2013
Results posted
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing oxaliplatin in people with Ovarian Cancer and Primary Peritoneal Cavity Cancer, run by Gynecologic Oncology Group at 74 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 21 Jun 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 74 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00005836.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jun 2013.

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