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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00031629
Other study ID # GOG-0131G
Secondary ID NCI-2012-02456CD
Status Completed
Phase Phase 2
First received March 8, 2002
Last updated December 7, 2016
Start date January 2005

Study information

Verified date December 2016
Source Gynecologic Oncology Group
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial Summary

Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. Colony-stimulating factors such as filgrastim or pegfilgrastim may increase the number of immune cells found in bone marrow or peripheral blood and may help a person's immune system recover from the side effects of chemotherapy. This phase II trial is studying how well combination chemotherapy plus filgrastim or pegfilgrastim works in treating patients with recurrent or persistent cancer of the uterus.


Description:

PRIMARY OBJECTIVES:

I. Determine the antitumor activity of docetaxel, gemcitabine, and filgrastim (G-CSF) or pegfilgrastim in patients with persistent or recurrent uterine leiomyosarcoma.

II. Determine the nature and degree of toxicity of this regimen in these patients.

OUTLINE:

Patients receive gemcitabine IV over 90 minutes on days 1 and 8, docetaxel IV over 1 hour on day 8, and filgrastim (G-CSF) subcutaneously (SC) on days 9-15 or pegfilgrastim SC on day 9 only. Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity.

Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter.

PROJECTED ACCRUAL: A total of 19-51 patients will be accrued for this study within 10-24 months.


Recruitment information / eligibility

Status Completed
Enrollment 51
Est. completion date
Est. primary completion date July 2007
Accepts healthy volunteers No
Gender Female
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Histologically confirmed uterine leiomyosarcoma

- Recurrent or persistent disease that is refractory to curative therapy or established treatments

- Must have received 1 prior chemotherapy regimen that may include high-dose therapy, consolidation, or extended therapy after surgical or nonsurgical assessment

- At least 1 unidimensionally measurable lesion

- At least 20 mm by conventional techniques

- At least 10 mm by spiral CT scan

- Lesions within a previously irradiated field allowed provided progression is documented or biopsy is obtained to confirm persistence at least 90 days following completion of radiation therapy

- Ineligible for a high priority GOG protocol

- Performance status - GOG 0-2

- Absolute neutrophil count at least 1,500/mm^3

- Platelet count at least 100,000/mm^3

- Bilirubin no greater than 1.1 times upper limit of normal (ULN)

- SGOT no greater than 2.5 times ULN

- Alkaline phosphatase no greater than 2.5 times ULN

- Creatinine no greater than 1.5 times ULN

- No active infection requiring antibiotics

- No motor or sensory neuropathy greater than grade 1

- No other malignancy within the past 5 years except nonmelanoma skin cancer

- Not pregnant

- Negative pregnancy test

- Fertile patients must use effective contraception

- No more than 1 prior non-cytotoxic (biologic or cytostatic) regimen (e.g., monoclonal antibodies, cytokines, or small-molecule signal transduction inhibitors) for recurrent or persistent disease

- At least 3 weeks since prior biologic or immunologic therapy for this disease

- See Disease Characteristics

- See Biologic therapy

- At least 3 weeks since prior chemotherapy and recovered

- No prior docetaxel or gemcitabine

- No other prior cytotoxic chemotherapy for recurrent or persistent disease, including retreatment with initial regimens

- No prior chemotherapy for another malignancy that would preclude study

- At least 1 week since prior hormonal therapy for this disease

- Concurrent hormone replacement therapy allowed

- See Disease Characteristics

- At least 3 weeks since prior radiotherapy and recovered

- See Disease Characteristics

- Recovered from prior recent surgery

- At least 3 weeks since other prior therapy for this disease

- No concurrent amifostine or other protective agents

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment


Intervention

Drug:
Docetaxel
Given IV
Biological:
Filgrastim
Given SC
Drug:
Gemcitabine Hydrochloride
Given IV
Biological:
Pegfilgrastim
Given IV

Locations

Country Name City State
United States Gynecologic Oncology Group Philadelphia Pennsylvania

Sponsors (2)

Lead Sponsor Collaborator
Gynecologic Oncology Group National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Frequency and duration of objective response Up to 5 years No
Primary Frequency of severity of observed adverse effects assessed using CTC version 2.0 The frequency and severity of all toxicities are tabulated from submitted case report forms and summarized for review. Up to 5 years Yes
See also
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Completed NCT00025506 - Thalidomide in Treating Patients With Recurrent or Persistent Carcinosarcoma of the Uterus Phase 2
Completed NCT00025220 - Thalidomide in Treating Patients With Recurrent or Persistent Cancer of the Uterus Phase 2
Completed NCT01220609 - Ixabepilone in Treating Patients With Recurrent or Persistent Leiomyosarcoma of the Uterus Previously Treated With Chemotherapy Phase 2
Terminated NCT01012297 - Gemcitabine Hydrochloride and Docetaxel With or Without Bevacizumab in Treating Patients With Advanced or Recurrent Uterine Leiomyosarcoma Phase 3
Completed NCT01548482 - Trebananib And Temsirolimus in Treating Patients With Solid Tumors That Are Metastatic or Cannot Be Removed by Surgery Phase 1
Completed NCT00114218 - Gemcitabine and Docetaxel in Treating Patients With Recurrent or Persistent Uterine Cancer Phase 2
Completed NCT01154452 - Vismodegib and Gamma-Secretase/Notch Signalling Pathway Inhibitor RO4929097 in Treating Patients With Advanced or Metastatic Sarcoma Phase 1/Phase 2
Completed NCT01098630 - Patient, Physician, and Nurse Factors Associated With Entry Onto Clinical Trials and Finishing Treatment in Patients With Primary or Recurrent Uterine, Endometrial, or Cervical Cancer
Completed NCT01247571 - Pazopanib Hydrochloride in Treating Patients With Recurrent or Persistent Uterine Cancer Phase 2
Completed NCT01637961 - Alisertib in Treating Patients With Recurrent or Persistent Leiomyosarcoma of the Uterus Phase 2