Docetaxel in Treating Patients With Refractory or Recurrent Advanced Gynecologic Cancer

Phase 1

Completed

• Conditions: Cervical Cancer; Endometrial Cancer; Fallopian Tube Cancer; Ovarian Cancer; Peritoneal Cavity Cancer; Sarcoma; Vaginal Cancer; Vulvar Cancer
• Interventions: Drug: docetaxel

• Registration Number: NCT00287885
• Lead Sponsor: Masonic Cancer Center, University of Minnesota

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.

Basic Information
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Recruitment & Eligibility
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Study & Design

Study Timeline

• Study Start: 2004-03
• Study First Submitted: 2006-02-06
• Study First Submitted QC: 2006-02-06
• Study First Posted: 2006-02-07
• Primary Completion: 2008-12
• Study Completion: 2008-12
• Status Verified: 2017-11
• Last Update Submitted: 2017-11-27
• Last Update Posted: 2017-11-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 18

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Metronomic Docetaxel	docetaxel	Docetaxel will be administered by daily injection via pre-filled syringes into the patient's accessed subcutaneous port.

Primary Outcome Measures

Name	Time	Method
Maximum Tolerated Dose	Up to 180 Days	Determine the maximum tolerated dose of metronomic docetaxel in patients with progressive or recurrent gynecologic cancer

Secondary Outcome Measures

Name	Time	Method
Response to Treatment	Up to 180 Days	Determine the response rate in patients treated with this drug.
Pharmacokinetics	Day 1 through Day 5	Determine the pharmacokinetics associated with this drug in these patients.