Clinical trial NCT00287885: Docetaxel in Treating Patients With Refractory or Recurrent Advanced Gynecologic Cancer
Official title: Phase I Study of Metronomic Daily Dosing of Docetaxel in Women With Progressive or Recurrent Gynecologic Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Cervical Cancer
Endometrial Cancer
Fallopian Tube Cancer
Ovarian Cancer
Peritoneal Cavity Cancer
Sarcoma
Vaginal Cancer
Vulvar Cancer
Keywords: 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
Lead sponsor: Masonic Cancer Center, University of Minnesota
Sponsor class: OTHER
First posted: 2006-02-07
Enrollment: 18
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.

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 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

Primary outcomes:
measure: Maximum Tolerated Dose
timeFrame: Up to 180 Days
Secondary outcomes:
measure: Response to Treatment
timeFrame: Up to 180 Days
measure: Pharmacokinetics
timeFrame: Day 1 through Day 5
Other outcomes:
Locations:
Study officials:
affiliation: Masonic Cancer Center, University of Minnesota
name: Levi S. Downs, MD
role: STUDY_CHAIR
References: