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Docetaxel in Treating Patients With Refractory or Recurrent Advanced Gynecologic Cancer
This study is ongoing, but not recruiting participants.
First Received: February 6, 2006   Last Updated: July 23, 2008   History of Changes
Sponsors and Collaborators: Masonic Cancer Center, University of Minnesota
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00287885
  Purpose

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
Cervical Cancer
Endometrial Cancer
Fallopian Tube Cancer
Ovarian Cancer
Peritoneal Cavity Cancer
Sarcoma
Vaginal Cancer
Vulvar Cancer
Drug: docetaxel
Phase I

MedlinePlus related topics: Cancer Ovarian Cancer Soft Tissue Sarcoma Vaginal Cancer Vulvar Cancer
Drug Information available for: Docetaxel
U.S. FDA Resources
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

Further study details as provided by National Cancer Institute (NCI):

Detailed Description:

OBJECTIVES:

Primary

  • Determine the maximum tolerated dose of metronomic docetaxel in patients with progressive or recurrent gynecologic cancer.

Secondary

  • Determine the response rate in patients treated with this drug.
  • Determine the pharmacokinetics associated with this drug in these patients.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Histologically confirmed advanced, refractory gynecologic cancer
  • Must have received prior chemotherapy

    • Residual or recurrent disease after initial or subsequent therapy
  • At least 1 site of bidimensionally measurable disease OR evaluable but radiographically nonmeasurable disease associated with CA-125 > 50 units/mL on two measurements at least one week apart
  • No known brain metastases

PATIENT CHARACTERISTICS:

  • ECOG performance status 0-1
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • WBC ≥ 4,000/mm^3
  • Absolute neutrophil count ≥ 1,500/mm^3
  • Platelet count ≥ 100,000/mm^3
  • Hemoglobin ≥ 8 g/dL
  • Bilirubin normal
  • Meets 1 of the following criteria:

    • Alkaline phosphatase (AP) normal AND SGOT or SGPT normal
    • AP ≤ 5 times ULN AND SGOT or SGPT normal
    • AP normal AND SGOT or SGPT ≤ 5 times ULN
    • AP ≤ 2.5 ULN AND SGOT or SGPT ≤ 1.5 times ULN
  • No history of myocardial infarction or congestive heart failure
  • No significant ischemic or valvular heart disease
  • No peripheral neuropathy > grade 2
  • No history of severe hypersensitivity to docetaxel or other drugs formulated with polysorbate 80
  • BUN ≤ 30 mg/dL
  • Creatinine ≤ 1.5 mg/dL
  • No other prior malignancy in the past 5 years except nonmelanoma skin cancer or carcinoma in situ of the cervix

PRIOR CONCURRENT THERAPY:

  • See Disease Characteristics
  • At least 2 weeks since prior hormonal or immunologic therapy
  • At least 4 weeks since prior cytotoxic chemotherapy (6 weeks for nitrosoureas and mitomycin C)
  • At least 4 weeks since prior radiotherapy
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00287885

Sponsors and Collaborators
Masonic Cancer Center, University of Minnesota
Investigators
Study Chair: Levi S. Downs, MD Masonic Cancer Center, University of Minnesota
  More Information

Additional Information:
No publications provided

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

Keywords provided by National Cancer Institute (NCI):
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

Study placed in the following topic categories:
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

Additional relevant MeSH terms:
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

ClinicalTrials.gov processed this record on May 07, 2009