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| Sponsor: | Gynecologic Oncology Group |
|---|---|
| Collaborator: |
National Cancer Institute (NCI) |
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00079430 |
Purpose
RATIONALE: Drugs used in chemotherapy, such as carboplatin and paclitaxel, work in different ways to stop tumor cells from dividing so they stop growing or die. Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Bevacizumab may also stop the growth of tumor cells by blocking blood flow to the tumor. It is not yet known whether carboplatin, paclitaxel, and bevacizumab are more effective than carboplatin and paclitaxel in treating ovarian epithelial or primary peritoneal cancer, or fallopian tube cancer.
PURPOSE: This phase I trial is studying the side effects and best dose of adjuvant intraperitoneal carboplatin when given together with paclitaxel and bevacizumab in treating patients who have undergone debulking surgery for stage II , stage III, or stage IV ovarian epithelial, primary peritoneal, or fallopian tube cancer.
| Condition | Intervention | Phase |
|---|---|---|
|
Fallopian Tube Cancer Ovarian Cancer Peritoneal Cavity Cancer |
Biological: bevacizumab Drug: carboplatin Drug: paclitaxel Procedure: adjuvant therapy |
Phase I |
| Study Type: | Interventional |
| Study Design: | Treatment |
| Official Title: | A Dose Escalating Phase I Study With An Expanded Cohort To Assess The Feasibility Of Intraperitoneal Carboplatin (NSC #214240) And Intravenous Paclitaxel (NSC # 673089) And Intravenous Paclitaxel, Intraperitoneal Carboplatin And NCI Supplied Intravenous Bevacizumab (NSC #704865,IND #7921) In Patients With Previously Untreated Epithelial Ovarian, Primary Peritoneal, Or Fallopian Tube Carcinoma |
| Estimated Enrollment: | 64 |
| Study Start Date: | June 2004 |
| Estimated Primary Completion Date: | July 2005 (Final data collection date for primary outcome measure) |
OBJECTIVES:
Primary
Secondary
OUTLINE: This is a multicenter, dose-escalation study of intraperitoneal carboplatin.
Patients receive paclitaxel IV over 3 hours followed by intraperitoneal carboplatin over 15 minutes on day 1 in course 1. Beginning in course 2, patients also receive bevacizumab IV over 30-90 minutes on day 1. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
Cohorts of 3-6 patients receive escalating doses of carboplatin until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. Once the MTD is determined, an additional 20-40 patients are treated at that dose level.
Patients are followed every 3 months for 1 year.
PROJECTED ACCRUAL: A total of 3-64 patients (3-24 for dose escalation and 20-40 for feasibility) will be accrued for this study within 15 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, primary peritoneal, or fallopian tube cancer
The following histologic epithelial cell types are eligible:
Synchronous primary endometrial cancer OR prior history of endometrial cancer allowed provided all of the following are true:
No poorly differentiated subtypes, including the following:
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Cardiovascular
No clinically significant cardiovascular disease, including any of the following:
Other
No prior history of abdominal fistula or gastrointestinal perforation within the past 3-6 months
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
At least 3 years since prior adjuvant chemotherapy for localized breast cancer
Endocrine therapy
Radiotherapy
At least 3 years since prior radiotherapy for localized cancer of the breast, head and neck, or skin
Surgery
Other
Contacts and Locations| United States, Iowa | |
| Holden Comprehensive Cancer Center at University of Iowa | Recruiting |
| Iowa City, Iowa, United States, 52242-1002 | |
| Contact: Cancer Information Service 800-237-1225 | |
| United States, New Jersey | |
| Cancer Institute of New Jersey at Cooper - Voorhees | Recruiting |
| Voorhees, New Jersey, United States, 08043 | |
| Contact: Clinical Trials Office - Cancer Institute of New Jersey at Coo 856-325-6757 | |
| United States, Ohio | |
| Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical Center | Recruiting |
| Columbus, Ohio, United States, 43210-1240 | |
| Contact: Ohio State University Cancer Clinical Trial Matching Service 866-627-7616 osu@emergingmed.com | |
| Case Comprehensive Cancer Center | Recruiting |
| Cleveland, Ohio, United States, 44106-5065 | |
| Contact: Clinical Trials Office - Case Comprehensive Cancer Center 800-641-2422 | |
| United States, Oklahoma | |
| Cancer Care Associates - Saint Francis Campus | Recruiting |
| Tulsa, Oklahoma, United States, 74136-1929 | |
| Contact: Robert S. Mannel, MD 405-271-8787 | |
| Oklahoma University Cancer Institute | Recruiting |
| Oklahoma City, Oklahoma, United States, 73104 | |
| Contact: Robert S. Mannel, MD 405-271-8787 | |
| United States, Pennsylvania | |
| Fox Chase Cancer Center - Philadelphia | Recruiting |
| Philadelphia, Pennsylvania, United States, 19111-2497 | |
| Contact: Clinical Trials Office - Fox Chase Cancer Center - Philadelphi 215-728-4790 | |
| United States, Rhode Island | |
| Women and Infants Hospital of Rhode Island | Recruiting |
| Providence, Rhode Island, United States, 02905 | |
| Contact: Clinical Trials Office - Women and Infants Hospital of Rhode I 401-274-1122 | |
| United States, Washington | |
| Fred Hutchinson Cancer Research Center | Recruiting |
| Seattle, Washington, United States, 98104 | |
| Contact: Benjamin E. Greer, MD 206-685-2463 | |
| University Cancer Center at University of Washington Medical Center | Recruiting |
| Seattle, Washington, United States, 98195-6043 | |
| Contact: Clinical Trials Office - University Cancer Center at Universit 206-616-8289 | |
| Japan | |
| Saitama Medical University International Medical Center | Recruiting |
| Saitama, Japan, 350-1298 | |
| Contact: Keiichi Fujiwara, MD, PhD 81-42-984-4637 | |
| Study Chair: | Mark A. Morgan, MD, FACOG, FACS | Fox Chase Cancer Center |
More Information
| Study ID Numbers: | CDR0000355741, GOG-9917 |
| Study First Received: | March 8, 2004 |
| Last Updated: | October 29, 2009 |
| ClinicalTrials.gov Identifier: | NCT00079430 History of Changes |
| Health Authority: | Unspecified |
|
stage III ovarian epithelial cancer stage II ovarian epithelial cancer stage IV ovarian epithelial cancer fallopian tube cancer ovarian undifferentiated adenocarcinoma Brenner tumor |
ovarian clear cell cystadenocarcinoma ovarian endometrioid adenocarcinoma ovarian mixed epithelial carcinoma ovarian mucinous cystadenocarcinoma ovarian serous cystadenocarcinoma peritoneal cavity cancer |
|
Molecular Mechanisms of Pharmacological Action Immunologic Factors Antineoplastic Agents Gonadal Disorders Physiological Effects of Drugs Urogenital Neoplasms Ovarian Diseases Bevacizumab Genital Diseases, Female Neoplasms by Site Therapeutic Uses Peritoneal Diseases Growth Inhibitors Angiogenesis Modulating Agents Endocrine Gland Neoplasms |
Ovarian Neoplasms Digestive System Neoplasms Growth Substances Mitosis Modulators Genital Neoplasms, Female Adjuvants, Immunologic Endocrine System Diseases Antimitotic Agents Carboplatin Abdominal Neoplasms Angiogenesis Inhibitors Fallopian Tube Neoplasms Pharmacologic Actions Adnexal Diseases Fallopian Tube Diseases |