Docetaxel in Treating Patients With Refractory or Recurrent Advanced Gynecologic Cancer
NCT ID: NCT00287885
Last Updated: 2017-11-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
18 participants
INTERVENTIONAL
2004-03-31
2008-12-31
Brief Summary
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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
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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.
Conditions
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Keywords
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Metronomic Docetaxel
Docetaxel will be administered by daily injection via pre-filled syringes into the patient's accessed subcutaneous port.
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
Interventions
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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 Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
FEMALE
No
Sponsors
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Masonic Cancer Center, University of Minnesota
OTHER
Responsible Party
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Principal Investigators
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Levi S. Downs, MD
Role: STUDY_CHAIR
Masonic Cancer Center, University of Minnesota
Other Identifiers
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UMN-WCC-35
Identifier Type: OTHER
Identifier Source: secondary_id
0307M50626
Identifier Type: OTHER
Identifier Source: secondary_id
2003LS034
Identifier Type: -
Identifier Source: org_study_id