Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Published Results
Trial Contact Information
Registry Information

Alternate Title

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

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase II	Treatment	Completed	Any age	NCI	GOG-0126N NCT00023907

Objectives

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

Entry Criteria

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)

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

Patient Characteristics:

Age:

• Any age

Performance status:

• GOG 0-2

Life expectancy:

• Not specified

Hematopoietic:

• Absolute neutrophil count at least 1,500/mm³
• Platelet count at least 100,000/mm³

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)

Expected Enrollment

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

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.

Markman M, Blessing J, Rubin SC, et al.: 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 101 (3): 436-40, 2006.[PUBMED Abstract]

Trial Contact Information

Trial Lead Organizations

Gynecologic Oncology Group

Maurie Markman, MD, Protocol chair(Contact information may not be current)		Ph: 216-445-6888; 800-862-7798

Registry Information
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
Trial Start Date		2001-07-02
Registered in ClinicalTrials.gov		NCT00023907
Date Submitted to PDQ		2001-07-10
Information Last Verified		2004-05-10
NCI Grant/Contract Number		CA27469

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