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A Phase II Evaluation of Weekly Paclitaxel in the Treatment of Recurrent or Persistent Platinum and Paclitaxel-Resistant Ovarian or Primary Peritoneal Cancer

Phase 2
Not Enrolling
Ovarian Cancer, Primary Peritoneal Cavity Cancer

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Trial Information

A Phase II Evaluation of Weekly Paclitaxel in the Treatment of Recurrent or Persistent Platinum and Paclitaxel-Resistant Ovarian or Primary Peritoneal Cancer


- 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

Inclusion Criteria


- 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

- 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

Type of Study:


Study Design:

Masking: Open Label, Primary Purpose: Treatment

Principal Investigator

Maurie Markman, MD

Investigator Role:

Study Chair

Investigator Affiliation:

The Cleveland Clinic


United States: Federal Government

Study ID:




Start Date:

July 2001

Completion Date:

Related Keywords:

  • Ovarian Cancer
  • Primary Peritoneal Cavity Cancer
  • recurrent ovarian epithelial cancer
  • primary peritoneal cavity cancer
  • Ovarian Neoplasms
  • Peritoneal Neoplasms
  • Neoplasms, Glandular and Epithelial



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