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Docetaxel in Treating Patients With Refractory or Recurrent Advanced Gynecologic Cancer

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ClinicalTrials.gov Identifier: NCT00287885
Recruitment Status : Completed
First Posted : February 7, 2006
Last Update Posted : November 29, 2017
Sponsor:
Information provided by (Responsible Party):
Masonic Cancer Center, University of Minnesota

Tracking Information
First Submitted Date  ICMJE February 6, 2006
First Posted Date  ICMJE February 7, 2006
Last Update Posted Date November 29, 2017
Study Start Date  ICMJE March 2004
Actual Primary Completion Date December 2008   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 6, 2012)
Maximum Tolerated Dose [ Time Frame: Up to 180 Days ]
Determine the maximum tolerated dose of metronomic docetaxel in patients with progressive or recurrent gynecologic cancer
Original Primary Outcome Measures  ICMJE Not Provided
Change History Complete list of historical versions of study NCT00287885 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: November 6, 2012)
  • Response to Treatment [ Time Frame: Up to 180 Days ]
    Determine the response rate in patients treated with this drug.
  • Pharmacokinetics [ Time Frame: Day 1 through Day 5 ]
    Determine the pharmacokinetics associated with this drug in these patients.
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Docetaxel in Treating Patients With Refractory or Recurrent Advanced Gynecologic Cancer
Official Title  ICMJE Phase I Study of Metronomic Daily Dosing of Docetaxel in Women With Progressive or Recurrent Gynecologic Cancer
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Cervical Cancer
  • Endometrial Cancer
  • Fallopian Tube Cancer
  • Ovarian Cancer
  • Peritoneal Cavity Cancer
  • Sarcoma
  • Vaginal Cancer
  • Vulvar Cancer
Intervention  ICMJE Drug: 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 Name: Taxotere
Study Arms  ICMJE Experimental: Metronomic Docetaxel
Docetaxel will be administered by daily injection via pre-filled syringes into the patient's accessed subcutaneous port.
Intervention: Drug: docetaxel
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 19, 2010)
18
Original Enrollment  ICMJE Not Provided
Actual Study Completion Date  ICMJE December 2008
Actual Primary Completion Date December 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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

Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00287885
Other Study ID Numbers  ICMJE 2003LS034
UMN-WCC-35 ( Other Identifier: Women's Cancer Center, University of Minnesota )
0307M50626 ( Other Identifier: IRB, University of Minnesota )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Masonic Cancer Center, University of Minnesota
Study Sponsor  ICMJE Masonic Cancer Center, University of Minnesota
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: Levi S. Downs, MD Masonic Cancer Center, University of Minnesota
PRS Account Masonic Cancer Center, University of Minnesota
Verification Date November 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP