Home
Search
Study Topics
Glossary
|
|
|
|
|
|
Sponsors and Collaborators: |
Gynecologic Oncology Group National Cancer Institute (NCI) |
---|---|
Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00814086 |
RATIONALE: Drugs used in chemotherapy, such as cisplatin and paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) 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 cisplatin given together with paclitaxel in treating patients with stage IIB, stage IIC, stage III, or stage IV ovarian epithelial cancer, fallopian tube cancer, or primary peritoneal cavity cancer.
Condition | Intervention | Phase |
---|---|---|
Cancer-Related Problem/Condition Endometrial Cancer Fallopian Tube Cancer Ovarian Cancer Peritoneal Cavity Cancer |
Drug: cisplatin Drug: paclitaxel Procedure: assessment of therapy complications |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment, Open Label |
Official Title: | A Phase I Feasibility Trial IP Cisplatin and IV Paclitaxel on Day One Followed by IP Paclitaxel on Day 8 Every 21 Days as Front-Line Treatment of Ovarian, Fallopian Tube and Primary Peritoneal Carcinoma |
Estimated Enrollment: | 40 |
Study Start Date: | March 2009 |
Estimated Primary Completion Date: | August 2010 (Final data collection date for primary outcome measure) |
OBJECTIVES:
Primary
Secondary
OUTLINE: This is a multicenter study.
Patients receive paclitaxel IV over 3 hours and cisplatin intraperitoneally (IP) on day 1 and paclitaxel IP on day 8. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
After completion of study therapy, patients are followed every 3 months for 1 year.
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed ovarian epithelial, fallopian tube, or primary peritoneal cavity cancer
Optimal or suboptimal residual disease after debulking surgery within the past 12 weeks
The following histologic epithelial cell types are eligible:
No synchronous primary endometrial cancer or a history of primary endometrial cancer unless all of the following conditions are met:
PATIENT CHARACTERISTICS:
None of the following:
No unstable angina or myocardial infarction within the past 6 months
PRIOR CONCURRENT THERAPY:
No prior targeted therapy for the management of ovarian epithelial or primary peritoneal cavity cancer including, but not limited to, the following:
Study ID Numbers: | CDR0000629746, GOG-9921 |
Study First Received: | December 20, 2008 |
Last Updated: | January 14, 2009 |
ClinicalTrials.gov Identifier: | NCT00814086 |
Health Authority: | Unspecified |
neurotoxicity chemotherapeutic agent toxicity gastrointestinal complications stage II ovarian epithelial cancer stage III ovarian epithelial cancer stage IV ovarian epithelial cancer fallopian tube cancer peritoneal cavity cancer |
ovarian serous cystadenocarcinoma endometrial adenocarcinoma ovarian mucinous cystadenocarcinoma ovarian undifferentiated adenocarcinoma ovarian clear cell cystadenocarcinoma ovarian mixed epithelial carcinoma Brenner tumor |
Cystadenocarcinoma, Serous Tooth Diseases Neurotoxicity Syndromes Gonadal Disorders Urogenital Neoplasms Ovarian Diseases Ovarian epithelial cancer Dental Caries Genital Diseases, Female Endometrial Neoplasms Cisplatin Peritoneal Diseases Uterine Neoplasms Endometrial cancer Endocrine Gland Neoplasms |
Ovarian cancer Ovarian Neoplasms Digestive System Neoplasms Neurotoxicity syndromes Genital Neoplasms, Female Uterine Diseases Endocrine System Diseases Abdominal Neoplasms Fallopian Tube Neoplasms Carcinoma Fallopian Tube Diseases Digestive System Diseases Paclitaxel Gastrointestinal Neoplasms Endocrinopathy |
Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Physiological Effects of Drugs Mitosis Modulators Antimitotic Agents Tooth Demineralization Pharmacologic Actions |
Adnexal Diseases Neoplasms Neoplasms by Site Radiation-Sensitizing Agents Therapeutic Uses Tubulin Modulators Antineoplastic Agents, Phytogenic |