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| Sponsor: | Gynecologic Oncology Group |
|---|---|
| Collaborator: |
National Cancer Institute (NCI) |
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00085358 |
Purpose
RATIONALE: Drugs used in chemotherapy, such as carboplatin, docetaxel, and paclitaxel, work in different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug and giving them in different ways may kill more tumor cells.
PURPOSE: This phase I trial is studying the side effects and best dose of intraperitoneal infusions of carboplatin when given together with intravenous infusions of either docetaxel or paclitaxel followed by intraperitoneal paclitaxel in treating patients with stage II, stage III, or stage IV ovarian epithelial, fallopian tube, or primary peritoneal cavity carcinoma (cancer).
| Condition | Intervention | Phase |
|---|---|---|
|
Fallopian Tube Cancer Ovarian Cancer Primary Peritoneal Cavity Cancer |
Biological: bevacizumab Drug: carboplatin Drug: docetaxel Drug: paclitaxel |
Phase I |
| Study Type: | Interventional |
| Study Design: | Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Phase I Trial Of Intravenous Paclitaxel Intraperitoneal Carboplatin And Intraperitoneal Paclitaxel Or Intravenous Docetaxel, Intraperitoneal Carboplatin, And Intraperitoneal Paclitaxel Or Intravenous Paclitaxel, Intraperitoneal Carboplatin, Intraperitoneal Paclitaxel And CTEP-Supplied Agent Bevacizumab (NSC 704865, IND 7921) In Patients With Previously Untreated Ovarian, Fallopian Tube Or Primary Peritoneal Carcinoma |
| Estimated Enrollment: | 40 |
| Study Start Date: | June 2004 |
| Primary Completion Date: | May 2011 (Final data collection date for primary outcome measure) |
OBJECTIVES:
OUTLINE: This is a multicenter, dose-escalation study of intraperitoneal (IP) carboplatin. Patients in the dose-escalation phase are not eligible to enter the feasibility phase.
Patients are followed every 3 months for 1 year.
PROJECTED ACCRUAL: A total of 3-40 patients will be accrued for this study (3-20 in the dose-escalation phase and 20 in the feasibility phase).
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed fallopian tube, ovarian epithelial, or primary peritoneal carcinoma
The following epithelial cell types are allowed:
Must have undergone prior surgery for ovarian or peritoneal carcinoma within the past 12 weeks
Synchronous primary endometrial cancer or prior endometrial cancer allowed provided the following criteria are met:
PATIENT CHARACTERISTICS:
No clinically significant proteinuria
No clinically significant cardiovascular disease, including any of the following (applies to part C only):
PRIOR CONCURRENT THERAPY:
No prior chemotherapy
No anticipation of invasive procedures, including any of the following (applies to part C only):
Contacts and Locations| United States, California | |
| Chao Family Comprehensive Cancer Center at University of California Irvine Medical Center | |
| Orange, California, United States, 92868 | |
| United States, Illinois | |
| University of Chicago Cancer Research Center | |
| Chicago, Illinois, United States, 60637-1470 | |
| United States, Iowa | |
| Holden Comprehensive Cancer Center at University of Iowa | |
| Iowa City, Iowa, United States, 52242-1002 | |
| United States, Missouri | |
| Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis | |
| Saint Louis, Missouri, United States, 63110 | |
| United States, New Jersey | |
| Cancer Institute of New Jersey at Cooper - Voorhees | |
| Voorhees, New Jersey, United States, 08043 | |
| United States, Oklahoma | |
| Oklahoma University Cancer Institute | |
| Oklahoma City, Oklahoma, United States, 73104 | |
| United States, Rhode Island | |
| Women and Infants Hospital of Rhode Island | |
| Providence, Rhode Island, United States, 02905 | |
| Study Chair: | Joan L. Walker, MD | Oklahoma University Cancer Institute |
| Investigator: | Natalie Gould, MD | Rocky Mountain Cancer Centers - Denver Midtown |
More Information
| ClinicalTrials.gov Identifier: | NCT00085358 History of Changes |
| Other Study ID Numbers: | CDR0000368755, GOG-9916 |
| Study First Received: | June 10, 2004 |
| Last Updated: | May 10, 2011 |
| Health Authority: | United States: Federal Government |
|
stage III ovarian epithelial cancer stage IV ovarian epithelial cancer stage II ovarian epithelial cancer fallopian tube cancer primary peritoneal cavity cancer ovarian serous cystadenocarcinoma ovarian endometrioid adenocarcinoma |
ovarian mucinous cystadenocarcinoma ovarian undifferentiated adenocarcinoma ovarian mixed epithelial carcinoma Brenner tumor ovarian clear cell cystadenocarcinoma ovarian carcinosarcoma |
|
Carcinoma Ovarian Neoplasms Peritoneal Neoplasms Fallopian Tube Neoplasms Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms Endocrine Gland Neoplasms Neoplasms by Site 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 Fallopian Tube Diseases Docetaxel Bevacizumab Carboplatin Paclitaxel Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Tubulin Modulators Antimitotic Agents |