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

Primary Purpose

Recurrent Uterine Corpus Sarcoma, Uterine Corpus Leiomyosarcoma

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Docetaxel
Filgrastim
Gemcitabine Hydrochloride
Pegfilgrastim
Sponsored by
Gynecologic Oncology Group
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Recurrent Uterine Corpus Sarcoma

Eligibility Criteria

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

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

Sites / Locations

  • Gynecologic Oncology Group

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Treatment (gemcitabine, docetaxel, G-CSF, pegfilgrastim)

Arm Description

Patients receive gemcitabine IV over 90 minutes on days 1 and 8, docetaxel IV over 1 hour on day 8, and G-CSF 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.

Outcomes

Primary Outcome Measures

Frequency and duration of objective response
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.

Secondary Outcome Measures

Full Information

First Posted
March 8, 2002
Last Updated
December 7, 2016
Sponsor
Gynecologic Oncology Group
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00031629
Brief Title
Combination Chemotherapy and Filgrastim or Pegfilgrastim in Treating Patients With Recurrent or Persistent Cancer of the Uterus
Official Title
A Phase II Evaluation of Docetaxel and Gemcitabine Plus G-CSF in the Treatment of Recurrent or Persistent Leiomyosarcoma of the Uterus
Study Type
Interventional

2. Study Status

Record Verification Date
December 2016
Overall Recruitment Status
Completed
Study Start Date
January 2005 (undefined)
Primary Completion Date
July 2007 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Gynecologic Oncology Group
Collaborators
National Cancer Institute (NCI)

4. Oversight

5. Study Description

Brief 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.
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Recurrent Uterine Corpus Sarcoma, Uterine Corpus Leiomyosarcoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
51 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Treatment (gemcitabine, docetaxel, G-CSF, pegfilgrastim)
Arm Type
Experimental
Arm Description
Patients receive gemcitabine IV over 90 minutes on days 1 and 8, docetaxel IV over 1 hour on day 8, and G-CSF 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.
Intervention Type
Drug
Intervention Name(s)
Docetaxel
Other Intervention Name(s)
Docecad, RP56976, Taxotere, Taxotere Injection Concentrate
Intervention Description
Given IV
Intervention Type
Biological
Intervention Name(s)
Filgrastim
Other Intervention Name(s)
Filgrastim XM02, Filgrastim-sndz, G-CSF, Neupogen, r-metHuG-CSF, Recombinant Methionyl Human Granulocyte Colony Stimulating Factor, rG-CSF, Tbo-filgrastim, Tevagrastim, Zarxio
Intervention Description
Given SC
Intervention Type
Drug
Intervention Name(s)
Gemcitabine Hydrochloride
Other Intervention Name(s)
dFdCyd, Difluorodeoxycytidine Hydrochloride, Gemzar, LY-188011, LY188011
Intervention Description
Given IV
Intervention Type
Biological
Intervention Name(s)
Pegfilgrastim
Other Intervention Name(s)
Filgrastim SD-01, filgrastim-SD/01, HSP-130, Neulasta, Neulastim, Pegfilgrastim Biosimilar HSP-130, SD-01, SD-01 sustained duration G-CSF
Intervention Description
Given IV
Primary Outcome Measure Information:
Title
Frequency and duration of objective response
Time Frame
Up to 5 years
Title
Frequency of severity of observed adverse effects assessed using CTC version 2.0
Description
The frequency and severity of all toxicities are tabulated from submitted case report forms and summarized for review.
Time Frame
Up to 5 years

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Martee Hensley
Organizational Affiliation
Gynecologic Oncology Group
Official's Role
Principal Investigator
Facility Information:
Facility Name
Gynecologic Oncology Group
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19103
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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