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A Phase II Evaluation of Weekly Paclitaxel (NSC #673089) and Celecoxib (Celebrex®, NSC #719627) in the Treatment of Recurrent or Persistent Platinum-Resistant Epithelial Ovarian or Primary Peritoneal Cancer

Phase 2
18 Years
Not Enrolling
Ovarian Cancer, Primary Peritoneal Cavity Cancer

Thank you

Trial Information

A Phase II Evaluation of Weekly Paclitaxel (NSC #673089) and Celecoxib (Celebrex®, NSC #719627) in the Treatment of Recurrent or Persistent Platinum-Resistant Epithelial Ovarian or Primary Peritoneal Cancer


- Determine the antitumor activity of paclitaxel and celecoxib in patients with recurrent
or persistent platinum-resistant ovarian epithelial or primary peritoneal cancer.

- Determine the nature and degree of toxicity of this regimen in these patients.

OUTLINE: This is a multicenter study.

Patients receive paclitaxel IV over 1 hour on days 1, 8, and 15 and oral celecoxib twice
daily on days 2-6, 9-13, and 16-27. Courses repeat every 28 days in the absence of disease
progression or unacceptable toxicity.

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

PROJECTED ACCRUAL: A total of 19-51 patients will be accrued for this study within 11-22

Inclusion Criteria


- Histologically confirmed ovarian epithelial or primary peritoneal cancer

- Recurrent or persistent disease

- Measurable disease

- At least 1 unidimensionally measurable lesion at least 20 mm by conventional
techniques OR at least 10 mm by spiral CT scan

- At least 1 target lesion not in a previously irradiated field

- Must have received 1 prior platinum-based chemotherapy regimen for primary disease
containing carboplatin, cisplatin, or another organoplatinum compound

- Initial treatment may have included high-dose therapy, consolidation, or
extended therapy administered after surgical or non-surgical assessment

- Platinum-resistant or refractory (i.e., had a treatment-free interval after
platinum therapy of less than 6 months OR disease progression during
platinum-based therapy)

- Patients who have not received a prior taxane may have received a second regimen
that included paclitaxel or docetaxel

- Must not be eligible for a higher priority GOG protocol



- Not specified

Performance status

- GOG 0-2

Life expectancy

- Not specified


- Absolute neutrophil count ≥ 1,500/mm^3

- Platelet count ≥ 100,000/mm^3


- SGOT ≤ 2.5 times upper limit of normal (ULN)

- Alkaline phosphatase ≤ 2.5 times ULN

- Bilirubin ≤ 1.5 times ULN


- Creatinine ≤ 1.5 times ULN


- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception

- No active infection requiring antibiotics

- No neuropathy (sensory and motor) > grade 1

- No history of peptic ulcer disease

- No allergies to sulfa or non-steroidal anti-inflammatory drugs

- No known hypersensitivity to paclitaxel or celecoxib

- No other invasive malignancy within the past 5 years except non-melanoma skin cancer


Biologic therapy

- At least 3 weeks since prior biologic or immunologic therapy

- One prior non-cytotoxic* regimen for recurrent or persistent disease allowed NOTE:
*Non-cytotoxic (biologic or cytostatic) agents include (but are not limited to)
monoclonal antibodies, cytokines, and small-molecule inhibitors of signal


- See Disease Characteristics

- Recovered from prior chemotherapy

- No other prior cytotoxic chemotherapy for recurrent or persistent disease, including
retreatment with initial chemotherapy regimen

Endocrine therapy

- At least 1 week since prior hormonal therapy for malignant tumor

- Concurrent hormone replacement therapy allowed


- See Disease Characteristics

- Recovered from prior radiotherapy

- No prior radiotherapy to more than 25% of marrow-bearing areas


- See Disease Characteristics

- Recovered from prior surgery


- At least 3 weeks since prior therapy for malignant tumor

- No prior celecoxib

- No prior therapy for a previous cancer that would preclude protocol therapy

- No concurrent amifostine or other protective agents

Type of Study:


Study Design:

Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Antitumor activity

Safety Issue:


Principal Investigator

Brigitte E. Miller, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Comprehensive Cancer Center of Wake Forest University


United States: Federal Government

Study ID:




Start Date:

April 2004

Completion Date:

Related Keywords:

  • Ovarian Cancer
  • Primary Peritoneal Cavity Cancer
  • recurrent ovarian epithelial cancer
  • primary peritoneal cavity cancer
  • Ovarian Neoplasms
  • Peritoneal Neoplasms



Holden Comprehensive Cancer Center at University of Iowa Iowa City, Iowa  52242-1002