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

This study has been terminated.
National Cancer Institute (NCI)
Information provided by:
Gynecologic Oncology Group Identifier:
First received: September 13, 2001
Last updated: April 10, 2013
Last verified: May 2004

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 Intervention Phase
Ovarian Cancer Primary Peritoneal Cavity Cancer Drug: paclitaxel Phase 2

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:

Further study details as provided by Gynecologic Oncology Group:

Study Start Date: July 2001
Primary Completion Date: April 2006 (Final data collection date for primary outcome measure)
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.


Ages Eligible for Study:   Child, Adult, Senior
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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00023907

  Show 44 Study Locations
Sponsors and Collaborators
Gynecologic Oncology Group
National Cancer Institute (NCI)
Study Chair: Maurie Markman, MD The Cleveland Clinic
  More Information

Publications: Identifier: NCT00023907     History of Changes
Other Study ID Numbers: CDR0000068875
Study First Received: September 13, 2001
Last Updated: April 10, 2013

Keywords provided by Gynecologic Oncology Group:
recurrent ovarian epithelial cancer
primary peritoneal cavity cancer

Additional relevant MeSH terms:
Peritoneal Neoplasms
Abdominal Neoplasms
Neoplasms by Site
Digestive System Neoplasms
Digestive System Diseases
Peritoneal Diseases
Albumin-Bound Paclitaxel
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action processed this record on August 18, 2017