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

Ovarian Cancer Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00084448
• Other study ID #: GOG_0126P
• Status: Terminated
• Phase: Phase 2
• First received: June 10, 2004
• Last updated: July 8, 2013
• Start date: April 2004

Study information

• Verified date: June 2005
• Source: Gynecologic Oncology Group
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial Summary

RATIONALE: Drugs used in chemotherapy, such as paclitaxel, work in different ways to stop tumor cells from dividing so they stop growing or die. Celecoxib may stop the growth of cancer by stopping blood flow to the tumor and may increase the effectiveness of paclitaxel by making tumor cells more sensitive to the drug. Giving celecoxib together with paclitaxel may kill more tumor cells.

PURPOSE: This phase II trial is studying how well giving paclitaxel together with celecoxib works in treating patients with recurrent or persistent platinum-resistant ovarian epithelial or primary peritoneal cancer.

Description:

OBJECTIVES:

• 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 months.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 0
• Est. primary completion date: May 2005
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

PATIENT CHARACTERISTICS:

Age

• Not specified

Performance status

• GOG 0-2

Life expectancy

• Not specified

Hematopoietic

• Absolute neutrophil count = 1,500/mm^3

• Platelet count = 100,000/mm^3

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

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

Study Design

Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Ovarian Cancer
• Peritoneal Neoplasms
• Primary Peritoneal Cavity Cancer

Intervention

Drug:
• celecoxib

• paclitaxel

Locations

Country	Name	City	State
United States	Holden Comprehensive Cancer Center at University of Iowa	Iowa City	Iowa

Sponsors (2)

Lead Sponsor	Collaborator
Gynecologic Oncology Group	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Antitumor activity			No
Primary	Toxicity			Yes