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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00023907
Recruitment Status : Terminated
First Posted : July 9, 2003
Last Update Posted : April 11, 2013
National Cancer Institute (NCI)
Information provided by:
GOG Foundation

Brief 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.

Condition or disease Intervention/treatment Phase
Ovarian Cancer Primary Peritoneal Cavity Cancer Drug: paclitaxel Phase 2

Detailed Description:


  • 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.

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Study Type : Interventional  (Clinical Trial)
Masking: None (Open Label)
Primary Purpose: Treatment
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
Study Start Date : July 2001
Actual Primary Completion Date : April 2006

Resource links provided by the National Library of Medicine

Drug Information available for: Paclitaxel

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No


  • 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)



  • Any age

Performance status:

  • GOG 0-2

Life expectancy:

  • Not specified


  • Absolute neutrophil count at least 1,500/mm^3
  • Platelet count at least 100,000/mm^3


  • 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


  • Creatinine no greater than 1.5 times ULN


  • 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)


Biologic therapy:

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


  • 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


  • 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


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


  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00023907

Show Show 44 study locations
Sponsors and Collaborators
Gynecologic Oncology Group
National Cancer Institute (NCI)
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Study Chair: Maurie Markman, MD The Cleveland Clinic
Publications of Results:
Layout table for additonal information Identifier: NCT00023907    
Other Study ID Numbers: CDR0000068875
First Posted: July 9, 2003    Key Record Dates
Last Update Posted: April 11, 2013
Last Verified: May 2004
Keywords provided by GOG Foundation:
recurrent ovarian epithelial cancer
primary peritoneal cavity cancer
Additional relevant MeSH terms:
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Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action