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

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

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.

Study Overview

• Status: Completed
• Conditions: Recurrent Uterine Corpus Sarcoma; Uterine Corpus Leiomyosarcoma
• Intervention / Treatment: Drug: Docetaxel; Drug: Gemcitabine Hydrochloride; Biological: Filgrastim; Biological: Pegfilgrastim

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.

• Study Type: Interventional
• Enrollment (Actual): 51
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19103
      • Gynecologic Oncology Group

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / 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: Taxotere; Docecad; RP56976; Taxotere Injection Concentrate; Drug: Gemcitabine Hydrochloride; Given IV; Other Names: Gemzar; dFdCyd; Difluorodeoxycytidine Hydrochloride; LY-188011; LY188011; Biological: Filgrastim; Given SC; Other Names: G-CSF; r-metHuG-CSF; Neupogen; Recombinant Methionyl Human Granulocyte Colony Stimulating Factor; rG-CSF; Tevagrastim; Zarxio; Filgrastim XM02; Tbo-filgrastim; Filgrastim-sndz; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Frequency and duration of objective response		Up to 5 years
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

Collaborators and Investigators

• Sponsor: Gynecologic Oncology Group
• Collaborators: National Cancer Institute (NCI)

Study record dates

Study Major Dates

• Study Start: January 1, 2005
• Primary Completion (ACTUAL): July 1, 2007

Study Registration Dates

• First Submitted: March 8, 2002
• First Submitted That Met QC Criteria: January 26, 2003
• First Posted (ESTIMATE): January 27, 2003

Study Record Updates

• Last Update Posted (ESTIMATE): December 8, 2016
• Last Update Submitted That Met QC Criteria: December 7, 2016
• Last Verified: December 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Disease Attributes; Sarcoma; Neoplasms, Muscle Tissue; Recurrence; Leiomyosarcoma; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Antiviral Agents; Enzyme Inhibitors; Antimetabolites, Antineoplastic; Antimetabolites; Antineoplastic Agents; Immunosuppressive Agents; Immunologic Factors; Tubulin Modulators; Antimitotic Agents; Mitosis Modulators; Adjuvants, Immunologic; Gemcitabine; Docetaxel; Lenograstim
• Other Study ID Numbers: GOG-0131G (OTHER: CTEP); U10CA027469 (U.S. NIH Grant/Contract); NCI-2012-02456 (REGISTRY: CTRP (Clinical Trial Reporting Program)); CDR0000069206