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Docetaxel in Treating Patients With Refractory or Recurrent Advanced Gynecologic Cancer

Primary Purpose

Cervical Cancer, Endometrial Cancer, Fallopian Tube Cancer

Status
Completed
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
docetaxel
Sponsored by
Masonic Cancer Center, University of Minnesota
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cervical Cancer focused on measuring 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

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Metronomic Docetaxel

    Arm Description

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

    Outcomes

    Primary Outcome Measures

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

    Secondary Outcome Measures

    Response to Treatment
    Determine the response rate in patients treated with this drug.
    Pharmacokinetics
    Determine the pharmacokinetics associated with this drug in these patients.

    Full Information

    First Posted
    February 6, 2006
    Last Updated
    November 27, 2017
    Sponsor
    Masonic Cancer Center, University of Minnesota
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00287885
    Brief Title
    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

    2. Study Status

    Record Verification Date
    November 2017
    Overall Recruitment Status
    Completed
    Study Start Date
    March 2004 (undefined)
    Primary Completion Date
    December 2008 (Actual)
    Study Completion Date
    December 2008 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Masonic Cancer Center, University of Minnesota

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    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

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 1
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    Non-Randomized
    Enrollment
    18 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Metronomic Docetaxel
    Arm Type
    Experimental
    Arm Description
    Docetaxel will be administered by daily injection via pre-filled syringes into the patient's accessed subcutaneous port.
    Intervention Type
    Drug
    Intervention Name(s)
    docetaxel
    Other Intervention Name(s)
    Taxotere
    Intervention Description
    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
    Primary Outcome Measure Information:
    Title
    Maximum Tolerated Dose
    Description
    Determine the maximum tolerated dose of metronomic docetaxel in patients with progressive or recurrent gynecologic cancer
    Time Frame
    Up to 180 Days
    Secondary Outcome Measure Information:
    Title
    Response to Treatment
    Description
    Determine the response rate in patients treated with this drug.
    Time Frame
    Up to 180 Days
    Title
    Pharmacokinetics
    Description
    Determine the pharmacokinetics associated with this drug in these patients.
    Time Frame
    Day 1 through Day 5

    10. Eligibility

    Sex
    Female
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Levi S. Downs, MD
    Organizational Affiliation
    Masonic Cancer Center, University of Minnesota
    Official's Role
    Study Chair

    12. IPD Sharing Statement

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    Docetaxel in Treating Patients With Refractory or Recurrent Advanced Gynecologic Cancer

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