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Sponsors and Collaborators: |
Masonic Cancer Center, University of Minnesota National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00287885 |
RATIONALE: Drugs used in chemotherapy, such as docetaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Docetaxel may also stop the growth of tumor cells by blocking blood flow to the tumor. Giving daily doses of docetaxel may kill more tumor cells.
PURPOSE: This phase I trial is studying the side effects and best dose of docetaxel in treating patients with refractory or recurrent advanced gynecologic cancer.
Condition | Intervention | Phase |
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Cervical Cancer Endometrial Cancer Fallopian Tube Cancer Ovarian Cancer Peritoneal Cavity Cancer Sarcoma Vaginal Cancer Vulvar Cancer |
Drug: docetaxel |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment |
Official Title: | Phase I Study of Metronomic Daily Dosing of Docetaxel in Women With Progressive or Recurrent Gynecologic Cancer |
OBJECTIVES:
Primary
Secondary
OUTLINE: This is a dose-escalation study.
Patients receive docetaxel IV over 1-2 minutes daily for up to 6 months in the absence of unacceptable toxicity.
Cohorts of 3-6 patients receive escalating doses of docetaxel 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.
After completion of study treatment, patients are followed every 3 months.
PROJECTED ACCRUAL: A total of 25 patients will be accrued for this study.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Must have received prior chemotherapy
PATIENT CHARACTERISTICS:
Meets 1 of the following criteria:
PRIOR CONCURRENT THERAPY:
Study ID Numbers: | CDR0000450904, UMN-2003LS034, UMN-WCC-35 |
Study First Received: | February 6, 2006 |
Last Updated: | July 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00287885 History of Changes |
Health Authority: | United States: Federal Government |
recurrent cervical cancer stage III cervical cancer stage IVA cervical cancer stage IVB cervical cancer stage III endometrial carcinoma recurrent endometrial carcinoma stage IV endometrial carcinoma fallopian tube cancer stage III ovarian epithelial cancer stage IV ovarian epithelial cancer stage III ovarian germ cell tumor recurrent ovarian germ cell tumor stage IV ovarian germ cell tumor recurrent ovarian epithelial cancer |
recurrent uterine sarcoma stage III uterine sarcoma stage IV uterine sarcoma stage III vaginal cancer recurrent vaginal cancer stage IVA vaginal cancer stage IVB vaginal cancer stage III vulvar cancer recurrent vulvar cancer stage IV vulvar cancer ovarian sarcoma ovarian stromal cancer peritoneal cavity cancer |
Fallopian Tube Cancer Gonadal Disorders Vulvar Cancer Vaginal Cancer Endometrial Cancer Urogenital Neoplasms Vaginal Diseases Ovarian Diseases Docetaxel Genital Diseases, Female Neoplasms, Connective and Soft Tissue Soft Tissue Sarcomas Endometrial Neoplasms Vulvar Neoplasms Peritoneal Diseases |
Ovarian Cancer Uterine Neoplasms Endocrine Gland Neoplasms Vaginal Neoplasms Ovarian Neoplasms Digestive System Neoplasms Genital Neoplasms, Female Uterine Diseases Endocrine System Diseases Ovarian Epithelial Cancer Abdominal Neoplasms Recurrence Fallopian Tube Neoplasms Carcinoma Fallopian Tube Diseases |
Antineoplastic Agents Gonadal Disorders Urogenital Neoplasms Vaginal Diseases Ovarian Diseases Docetaxel Genital Diseases, Female Neoplasms, Connective and Soft Tissue Endometrial Neoplasms Neoplasms by Site Vulvar Neoplasms Therapeutic Uses Peritoneal Diseases Uterine Neoplasms Endocrine Gland Neoplasms |
Vaginal Neoplasms Neoplasms by Histologic Type Ovarian Neoplasms Digestive System Neoplasms Genital Neoplasms, Female Uterine Diseases Endocrine System Diseases Abdominal Neoplasms Pharmacologic Actions Fallopian Tube Neoplasms Adnexal Diseases Fallopian Tube Diseases Neoplasms Digestive System Diseases Sarcoma |