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Phase I Study of Metronomic Daily Dosing of Docetaxel in Women With Progressive or Recurrent Gynecologic Cancer

Phase 1
18 Years
Not Enrolling
Cervical Cancer, Endometrial Cancer, Fallopian Tube Cancer, Ovarian Cancer, Peritoneal Cavity Cancer, Sarcoma, Vaginal Cancer, Vulvar Cancer

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Trial Information

Phase I Study of Metronomic Daily Dosing of Docetaxel in Women With Progressive or Recurrent Gynecologic Cancer



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


- 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.

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

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Maximum Tolerated Dose

Outcome Description:

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

Outcome Time Frame:

Up to 180 Days

Safety Issue:


Principal Investigator

Levi S. Downs, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Masonic Cancer Center, University of Minnesota


United States: Food and Drug Administration

Study ID:




Start Date:

March 2004

Completion Date:

December 2008

Related Keywords:

  • Cervical Cancer
  • Endometrial Cancer
  • Fallopian Tube Cancer
  • Ovarian Cancer
  • Peritoneal Cavity Cancer
  • Sarcoma
  • Vaginal Cancer
  • Vulvar Cancer
  • 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
  • Endometrial Neoplasms
  • Uterine Cervical Neoplasms
  • Ovarian Neoplasms
  • Vaginal Neoplasms
  • Vulvar Neoplasms
  • Peritoneal Neoplasms
  • Fallopian Tube Neoplasms
  • Adenoma
  • Sarcoma