Combination Chemotherapy and Filgrastim or Pegfilgrastim in Treating Patients With Recurrent or Persistent Cancer of the Uterus

Recurrent Uterine Corpus Sarcoma Clinical Trial

Official title:

A Phase II Evaluation of Docetaxel and Gemcitabine Plus G-CSF in the Treatment of Recurrent or Persistent Leiomyosarcoma of the Uterus

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. 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

Related Conditions & MeSH terms

• Leiomyosarcoma
• Recurrent Uterine Corpus Sarcoma
• Uterine Corpus Leiomyosarcoma

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