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

Sponsor

Gynecologic Oncology Group (Other)

Overall Status

Completed

CT.gov ID

NCT00031629

Collaborator

National Cancer Institute (NCI) (NIH)

Enrollment

Location

Arm

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Recurrent Uterine Corpus Sarcoma Uterine Corpus Leiomyosarcoma	Drug: Docetaxel Biological: Filgrastim Drug: Gemcitabine Hydrochloride Biological: Pegfilgrastim	Phase 2

Detailed Description

PRIMARY OBJECTIVES:

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

Study Design

Study Type:

Interventional

Actual Enrollment :

51 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

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 Start Date :

Jan 1, 2005

Actual Primary Completion Date :

Jul 1, 2007

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Treatment (gemcitabine, docetaxel, G-CSF, pegfilgrastim) 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.	Drug: Docetaxel Given IV Other Names: Docecad RP56976 Taxotere Taxotere Injection Concentrate Biological: Filgrastim Given SC Other Names: Filgrastim XM02 Filgrastim-sndz G-CSF Neupogen r-metHuG-CSF Recombinant Methionyl Human Granulocyte Colony Stimulating Factor rG-CSF Tbo-filgrastim Tevagrastim Zarxio Drug: Gemcitabine Hydrochloride Given IV Other Names: dFdCyd Difluorodeoxycytidine Hydrochloride Gemzar LY-188011 LY188011 Biological: Pegfilgrastim Given IV Other Names: Filgrastim SD-01 filgrastim-SD/01 HSP-130 Neulasta Neulastim Pegfilgrastim Biosimilar HSP-130 SD-01 SD-01 sustained duration G-CSF

Arm

Intervention/Treatment

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

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.

Drug: Docetaxel

Given IV

Other Names:

Docecad

RP56976

Taxotere

Taxotere Injection Concentrate

Biological: Filgrastim

Given SC

Other Names:

Filgrastim XM02

Filgrastim-sndz

G-CSF

Neupogen

r-metHuG-CSF

Recombinant Methionyl Human Granulocyte Colony Stimulating Factor

rG-CSF

Tbo-filgrastim

Tevagrastim

Zarxio

Drug: Gemcitabine Hydrochloride

Given IV

Other Names:

dFdCyd

Difluorodeoxycytidine Hydrochloride

Gemzar

LY-188011

LY188011

Biological: Pegfilgrastim

Given IV

Other Names:

Filgrastim SD-01

filgrastim-SD/01

HSP-130

Neulasta

Neulastim

Pegfilgrastim Biosimilar HSP-130

SD-01

SD-01 sustained duration G-CSF

Outcome Measures

Primary Outcome Measures

Frequency and duration of objective response [Up to 5 years]
Frequency of severity of observed adverse effects assessed using CTC version 2.0 [Up to 5 years]
The frequency and severity of all toxicities are tabulated from submitted case report forms and summarized for review.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Female

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Gynecologic Oncology Group	Philadelphia	Pennsylvania	United States	19103

Sponsors and Collaborators

Gynecologic Oncology Group
National Cancer Institute (NCI)

Investigators

Principal Investigator: Martee Hensley, Gynecologic Oncology Group

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Gynecologic Oncology Group

ClinicalTrials.gov Identifier:

NCT00031629

Other Study ID Numbers:

GOG-0131G
NCI-2012-02456
CDR0000069206
GOG-0131G
GOG-0131G
U10CA027469

First Posted:

Jan 27, 2003

Last Update Posted:

Dec 8, 2016

Last Verified:

Dec 1, 2016

Additional relevant MeSH terms:

Study Results

No Results Posted as of Dec 8, 2016