Docetaxel in Treating Patients With Refractory or Recurrent Advanced Gynecologic Cancer

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Masonic Cancer Center, University of Minnesota
ClinicalTrials.gov Identifier:
NCT00287885
First received: February 6, 2006
Last updated: November 6, 2012
Last verified: November 2012
  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 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase I Study of Metronomic Daily Dosing of Docetaxel in Women With Progressive or Recurrent Gynecologic Cancer

Resource links provided by NLM:


Further study details as provided by Masonic Cancer Center, University of Minnesota:

Primary Outcome Measures:
  • Maximum Tolerated Dose [ Time Frame: Up to 180 Days ] [ Designated as safety issue: Yes ]
    Determine the maximum tolerated dose of metronomic docetaxel in patients with progressive or recurrent gynecologic cancer


Secondary Outcome Measures:
  • Response to Treatment [ Time Frame: Up to 180 Days ] [ Designated as safety issue: Yes ]
    Determine the response rate in patients treated with this drug.

  • Pharmacokinetics [ Time Frame: Day 1 through Day 5 ] [ Designated as safety issue: No ]
    Determine the pharmacokinetics associated with this drug in these patients.


Enrollment: 18
Study Start Date: March 2004
Study Completion Date: December 2008
Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Metronomic Docetaxel
Docetaxel will be administered by daily injection via pre-filled syringes into the patient's accessed subcutaneous port.
Drug: docetaxel
Three patients will be enrolled and dosed at each level; from dose level 1 of 2.9 mg/m^2/day up to dose level 6 of 6.4 mg/m^2/day
Other Name: Taxotere

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 intravenously (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.

  Eligibility

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

Inclusion Criteria:

  • Patients must have histologically confirmed advanced, refractory gynecologic cancer.
  • Patients must have received prior chemotherapy, and must have residual or recurrent disease after initial therapy or after subsequent therapy.
  • Patients must have at least one site of bi-dimensional measurable disease as defined in section 9 or must have evaluable but radiographically non-measurable disease associated with CA-125 > 50 units/ml on two measurements at least one week apart. Baseline measurements and CA-125 must be obtained for all patients within four weeks before registration.
  • Patients must have Eastern Cooperative Oncology Group (ECOG) performance status 0-1.
  • Patients must not have received any hormonal or immunologic therapy for 2 weeks or cytotoxic chemotherapy or radiation therapy for 4 weeks (nitrosoureas and mitomycin C require 6 weeks) prior to registration.
  • Patients may not have a history of prior malignancy in the past 5 years other than non-melanoma skin cancer or in situ carcinoma of the cervix.
  • Patients must have documented adequate organ function within 4 weeks of registration defined as:

    • Marrow: WBC ≥ 3000/mm3, ANC ≥ 1500/mm3 , Hgb ≥ 8.0 g/dl, platelets ≥ 100,000/mm3
    • Hepatic: Total Bilirubin ≤ ULN, SGOT or SGPT and Alkaline Phosphatase must be within the range allowing for eligibility, as in the table below
    • SGOT or SGPT: 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
    • Renal: BUN ≤ 30 mg%, creatinine ≤ 1.5 mg%
  • Age ≥ 18 years

Exclusion Criteria:

  • Pregnant or lactating. The agents used in this study may be teratogenic to a fetus and there is no information on the excretion of agents into breast milk.
  • Patients of reproductive potential must use effective birth control, preferably with barrier methods.
  • Prior history of myocardial infarction, congestive heart failure or significant ischemic or valvular heart disease.
  • Patients with known brain metastases are not eligible.
  • Peripheral neuropathy must be ≤ grade 2.
  • Patients with a history of severe hypersensitivity reaction to docetaxel or other drugs formulated with polysorbate 80 must be excluded.

Patient must given written informed consent indicating the investigational nature of the treatment and its potential risks

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Responsible Party: Masonic Cancer Center, University of Minnesota
ClinicalTrials.gov Identifier: NCT00287885     History of Changes
Other Study ID Numbers: 2003LS034, UMN-WCC-35, 0307M50626
Study First Received: February 6, 2006
Last Updated: November 6, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Masonic Cancer Center, University of Minnesota:
recurrent cervical cancer
stage III cervical cancer
stage IVA cervical cancer
stage IVB cervical cancer
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
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 stromal cancer
peritoneal cavity cancer
stage III endometrial carcinoma
recurrent endometrial carcinoma
stage IV endometrial carcinoma
recurrent uterine sarcoma
stage III uterine sarcoma
stage IV uterine sarcoma
ovarian sarcoma

Additional relevant MeSH terms:
Endometrial Neoplasms
Uterine Cervical Neoplasms
Ovarian Neoplasms
Vaginal Neoplasms
Vulvar Neoplasms
Peritoneal Neoplasms
Fallopian Tube Neoplasms
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Endocrine Gland Neoplasms
Vaginal Diseases
Abdominal Neoplasms
Digestive System Neoplasms
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Sarcoma
Uterine Diseases
Genital Diseases, Female
Uterine Cervical Diseases
Ovarian Diseases
Adnexal Diseases
Endocrine System Diseases
Gonadal Disorders
Vulvar Diseases
Digestive System Diseases
Peritoneal Diseases
Fallopian Tube Diseases

ClinicalTrials.gov processed this record on August 26, 2014