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Ovarian CancerPhase 2NCT00023907

Paclitaxel in Treating Patients With Ovarian Epithelial Cancer or Primary Peritoneal Cancer

A Phase 2 study testing paclitaxel in people with Ovarian Cancer and Primary Peritoneal Cavity Cancer, run by Gynecologic Oncology Group at 44 sites in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

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 paclitaxel in treating patients who have recurrent or persistent ovarian epithelial cancer or primary peritoneal cancer. Read more about this study

Who is it for?
Any age, women only
What is being tested?
paclitaxel
How many people
Not given
Where
44 sitesUnited States
Study dates
Jul 2001to Apr 2006
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 persistent ovarian epithelial or primary peritoneal cancer
  • Measurable disease
  • At least 1 lesion measured in at least 1 dimension
  • At least 20 mm by conventional techniques OR
  • At least 10 mm by spiral CT scan
  • At least 1 target lesion
  • Tumors within a previously irradiated field considered non-target lesions
  • Paclitaxel resistant
  • Treatment-free interval of less than 6 months duration after treatment with prior paclitaxel OR
  • Progression during prior paclitaxel-based therapy
  • Platinum resistant or refractory
  • Treatment-free interval of less than 6 months duration after treatment with prior platinum OR
  • Progression during prior platinum-based therapy
  • Ineligible for higher priority GOG protocol (any active GOG phase III protocol for the same patient population)

PATIENT CHARACTERISTICS:

Age:

  • Any age

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 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

Other:

  • Not pregnant
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • No active infection requiring antibiotics
  • No other prior invasive malignancy within the past 5 years except nonmelanoma skin cancer
  • No grade 2 or greater neuropathy (sensory and motor)

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • At least 3 weeks since prior biologic or immunologic agents for cancer

Chemotherapy:

  • See Disease Characteristics
  • At least 3 weeks since prior chemotherapy for cancer and recovered
  • Received at least 1 but no more than 2 prior platinum-based chemotherapy regimens containing carboplatin, cisplatin, or other organoplatinum compound for primary or recurrent disease
  • Initial treatment may include high-dose therapy, consolidation, or extended therapy
  • Received at least 1 prior paclitaxel-based chemotherapy regimen
  • No prior paclitaxel or docetaxel with a schedule of less than a 3-week interval between doses
  • No additional prior cytotoxic chemotherapy for recurrent or persistent disease, including retreatment with initial chemotherapy regimens

Endocrine therapy:

  • At least 1 week since prior hormonal therapy for cancer
  • Concurrent hormone replacement therapy allowed

Radiotherapy:

  • See Disease Characteristics
  • At least 3 weeks since prior radiotherapy for cancer and recovered
  • No prior radiotherapy to site(s) of measurable disease
  • No prior radiotherapy to more than 25% of marrow-bearing areas

Surgery:

  • At least 3 weeks since prior surgery for cancer and recovered

Other:

  • At least 3 weeks since other prior therapy for cancer
  • No prior anticancer treatment that would preclude study
  • No concurrent amifostine or other protective reagents

Trial locations and contacts

44 sites in 1 country.

44 sites in 1 country

United States44 sites

  • Abington Memorial Hospital

    Abington, Pennsylvania, 19001-3788

  • CCOP - Michigan Cancer Research Consortium

    Ann Arbor, Michigan, 48106

  • Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support

    Bethesda, Maryland, 20892-1182

  • Roswell Park Cancer Institute

    Buffalo, New York, 14263-0001

  • Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill

    Chapel Hill, North Carolina, 27599-7295

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

    Chicago, Illinois, 60612-3824

  • MBCCOP - University of Illinois at Chicago

    Chicago, Illinois, 60612

  • Charles M. Barrett Cancer Center at University Hospital

    Cincinnati, Ohio, 45267-0526

  • Ireland Cancer Center

    Cleveland, Ohio, 44106

  • Cleveland Clinic Taussig Cancer Center

    Cleveland, Ohio, 44195

  • Ellis Fischel Cancer Center at University of Missouri - Columbia

    Columbia, Missouri, 65203

  • Arthur G. James Cancer Hospital - Ohio State University

    Columbus, Ohio, 43210-1240

  • CCOP - Geisinger Clinic and Medical Center

    Danville, Pennsylvania, 17822-2001

  • Duke Comprehensive Cancer Center

    Durham, North Carolina, 27710

  • CCOP - Evanston

    Evanston, Illinois, 60201

  • University of Texas Medical Branch

    Galveston, Texas, 77555-0587

  • CCOP - Grand Rapids

    Grand Rapids, Michigan, 49503

  • Penn State Cancer Institute at Milton S. Hershey Medical Center

    Hershey, Pennsylvania, 17033-0850

  • MBCCOP - Hawaii

    Honolulu, Hawaii, 96813

  • Indiana University Cancer Center

    Indianapolis, Indiana, 46202-5289

  • Holden Comprehensive Cancer Center at University of Iowa

    Iowa City, Iowa, 52242-1002

  • CCOP - Kalamazoo

    Kalamazoo, Michigan, 49007-3731

  • CCOP - Kansas City

    Kansas City, Missouri, 64131

  • Keesler Medical Center - Keesler Air Force Base

    Keesler Air Force Base, Mississippi, 39534-2576

  • Southeast Gynecologic Oncology Associates

    Knoxville, Tennessee, 37917

  • Markey Cancer Center at University of Kentucky Chandler Medical Center

    Lexington, Kentucky, 40536-0084

  • Women's Cancer Center at Community Hospital of Los Gatos

    Los Gatos, California, 95032

  • CCOP - Marshfield Clinic Research Foundation

    Marshfield, Wisconsin, 54449

  • Genecologic Oncology Network

    Nashville, Tennessee, 37203

  • Vanderbilt-Ingram Cancer Center at Vanderbilt Medical Center

    Nashville, Tennessee, 37232-2516

  • CCOP - Christiana Care Health Services

    Newark, Delaware, 19713

  • CCOP - Missouri Valley Cancer Consortium

    Omaha, Nebraska, 68106

  • Chao Family Comprehensive Cancer Center at University of California Irvine Cancer Center

    Orange, California, 92868

  • Fox Chase Cancer Center

    Philadelphia, Pennsylvania, 19111

  • CCOP - Western Regional, Arizona

    Phoenix, Arizona, 85006-2726

  • Magee-Womens Hospital

    Pittsburgh, Pennsylvania, 15213-3180

  • CCOP - Columbia River Oncology Program

    Portland, Oregon, 97225

  • CCOP - Metro-Minnesota

    Saint Louis Park, Minnesota, 55416

  • Saint Joseph Regional Medical Center

    South Bend, Indiana, 46617

  • Memorial Medical Center

    Springfield, Illinois, 62794-9640

  • CCOP - Cancer Research for the Ozarks

    Springfield, Missouri, 65807

  • CCOP - Scott and White Hospital

    Temple, Texas, 76508

  • CCOP - Carle Cancer Center

    Urbana, Illinois, 61801

  • Comprehensive Cancer Center at Wake Forest University

    Winston-Salem, North Carolina, 27157-1065

Other trials in United States

About this study

Official title: A Phase II Evaluation of Weekly Paclitaxel in the Treatment of Recurrent or Persistent Platinum and Paclitaxel-Resistant Ovarian or Primary Peritoneal 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 paclitaxel in treating patients who have recurrent or persistent ovarian epithelial cancer or primary peritoneal cancer.

Read the detailed description

OBJECTIVES:

  • Determine the antitumor activity of paclitaxel in patients with recurrent or persistent platinum- and paclitaxel-resistant ovarian epithelial or primary peritoneal cancer.
  • Determine the nature and degree of toxicity of this drug in these patients.

OUTLINE: Patients receive paclitaxel IV over 1 hour once weekly for 4 weeks. Treatment repeats every 4 weeks in the absence of disease progression or unacceptable toxicity.

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

PROJECTED ACCRUAL: Approximately 19-51 patients will be accrued for this study within 6-12 months.

Being tested
paclitaxel
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 posted9 Jul 2003 (estimated)
  2. Study startJul 2001
  3. Primary completionApr 2006

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
Masking
None (open label)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00023907
Sponsor's protocol ID
CDR0000068875
Other IDs
GOG-0126N
Status last verified
May 2004
First submitted
13 Sep 2001
Last updated
11 Apr 2013
Results posted
No

Publications

  • Gynecologic Oncology Group; Markman M, Blessing J, Rubin SC, Connor J, Hanjani P, Waggoner S. Phase II trial of weekly paclitaxel (80 mg/m2) in platinum and paclitaxel-resistant ovarian and primary peritoneal cancers: a Gynecologic Oncology Group study. Gynecol Oncol. 2006 Jun;101(3):436-40. doi: 10.1016/j.ygyno.2005.10.036. Epub 2005 Dec 2.

    PubMed 16325893

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing paclitaxel in people with Ovarian Cancer and Primary Peritoneal Cavity Cancer, run by Gynecologic Oncology Group at 44 sites in United States.

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

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 11 Apr 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 44 sites in United States. 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 was stopped early. Results are not available in the source record.

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 NCT00023907, which also lists 1 linked publication.

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 11 Apr 2013; AzTrials last refreshed its copy on 8 Nov 2026.

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