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| Sponsor: | Gynecologic Oncology Group |
|---|---|
| Collaborator: |
National Cancer Institute (NCI) |
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00084448 |
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Ovarian Cancer Primary Peritoneal Cavity Cancer |
Drug: celecoxib Drug: paclitaxel |
Phase II |
| Study Type: | Interventional |
| Study Design: | Masking: Open Label Primary Purpose: Treatment |
| 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 |
| Study Start Date: | April 2004 |
OBJECTIVES:
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed ovarian epithelial or primary peritoneal cancer
Measurable disease
Must have received 1 prior platinum-based chemotherapy regimen for primary disease containing carboplatin, cisplatin, or another organoplatinum compound
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
Contacts and Locations| United States, Iowa | |
| Holden Comprehensive Cancer Center at University of Iowa | |
| Iowa City, Iowa, United States, 52242-1002 | |
| Study Chair: | Brigitte E. Miller, MD | Comprehensive Cancer Center of Wake Forest University |
| Investigator: | Adnan Munkarah, MD | Barbara Ann Karmanos Cancer Institute |
More Information
| ClinicalTrials.gov Identifier: | NCT00084448 History of Changes |
| Other Study ID Numbers: | CDR0000365312, GOG-0126P |
| Study First Received: | June 10, 2004 |
| Last Updated: | April 23, 2011 |
| Health Authority: | United States: Federal Government |
|
recurrent ovarian epithelial cancer primary peritoneal cavity cancer |
|
Ovarian Neoplasms Peritoneal Neoplasms Endocrine Gland Neoplasms Neoplasms by Site Neoplasms Ovarian Diseases Adnexal Diseases Genital Diseases, Female Genital Neoplasms, Female Urogenital Neoplasms Endocrine System Diseases Gonadal Disorders Abdominal Neoplasms Digestive System Neoplasms Digestive System Diseases |
Peritoneal Diseases Paclitaxel Celecoxib Tubulin Modulators Antimitotic Agents Mitosis Modulators Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Antineoplastic Agents, Phytogenic Antineoplastic Agents Therapeutic Uses Cyclooxygenase 2 Inhibitors Cyclooxygenase Inhibitors Enzyme Inhibitors Anti-Inflammatory Agents, Non-Steroidal |