Docetaxel in Treating Patients With Refractory or Recurrent Advanced Gynecologic Cancer

Ovarian Cancer Clinical Trial

Official title:

Phase I Study of Metronomic Daily Dosing of Docetaxel in Women With Progressive or Recurrent Gynecologic Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00287885
• Other study ID #: 2003LS034
• Secondary ID: UMN-WCC-350307M5
• Status: Completed
• Phase: Phase 1
• First received: February 6, 2006
• Last updated: November 27, 2017
• Start date: March 2004
• Est. completion date: December 2008

Study information

• Verified date: November 2017
• Source: Masonic Cancer Center, University of Minnesota
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: December 2008
• Est. primary completion date: December 2008
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cervical Cancer
• Endometrial Cancer
• Endometrial Neoplasms
• Fallopian Tube Cancer
• Fallopian Tube Neoplasms
• Ovarian Cancer
• Peritoneal Cavity Cancer
• Peritoneal Neoplasms
• Sarcoma
• Uterine Cervical Neoplasms
• Vaginal Cancer
• Vaginal Neoplasms
• Vulvar Cancer
• Vulvar Neoplasms

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Masonic Cancer Center, University of Minnesota

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maximum Tolerated Dose	Determine the maximum tolerated dose of metronomic docetaxel in patients with progressive or recurrent gynecologic cancer	Up to 180 Days
Secondary	Response to Treatment	Determine the response rate in patients treated with this drug.	Up to 180 Days
Secondary	Pharmacokinetics	Determine the pharmacokinetics associated with this drug in these patients.	Day 1 through Day 5