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

Alternate Title

Paclitaxel and Celecoxib in Treating Patients With Recurrent or Persistent Platinum-Resistant Ovarian Epithelial or Primary Peritoneal Cancer

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase II	Treatment	Completed	18 and over	NCI	GOG-0126P NCT00084448

Objectives

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

Entry Criteria

Disease Characteristics:

• 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

Prior/Concurrent Therapy:

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 transduction]

Chemotherapy

• 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

Radiotherapy

• See Disease Characteristics
• Recovered from prior radiotherapy
• No prior radiotherapy to more than 25% of marrow-bearing areas

Surgery

• See Disease Characteristics
• Recovered from prior surgery

Other

• 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

Patient Characteristics:

Age

• Not specified

Performance status

• GOG 0-2

Life expectancy

• Not specified

Hematopoietic

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

Hepatic

• SGOT ≤ 2.5 times upper limit of normal (ULN)
• Alkaline phosphatase ≤ 2.5 times ULN
• Bilirubin ≤ 1.5 times ULN

Renal

• Creatinine ≤ 1.5 times ULN

Other

• 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

Expected Enrollment

A total of 19-51 patients will be accrued for this study within 11-22 months.

Outcomes

Antitumor activity
Toxicity

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.

Trial Contact Information

Trial Lead Organizations

Gynecologic Oncology Group

Brigitte Miller, MD, Protocol chair		Ph: 336-716-6673; 800-446-2255 Email: bemiller@wfubmc.edu
Adnan Munkarah, MD, Protocol co-chair		Ph: 313-745-0735; 800-527-6266 Email: amunkara@med.wayne.edu

Registry Information
Official Title		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
Trial Start Date		2004-04-05
Registered in ClinicalTrials.gov		NCT00084448
Date Submitted to PDQ		2004-03-30
Information Last Verified		2005-06-23
NCI Grant/Contract Number		CA27469

Back to Top