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

Gynecologic Oncology Group (GOG)

Status and phase: Completed; Phase 2

Conditions: Uterine Corpus Leiomyosarcoma; Recurrent Uterine Corpus Sarcoma

Treatments: Drug: Gemcitabine Hydrochloride; Biological: Pegfilgrastim; Drug: Docetaxel; Biological: Filgrastim

Study type: Interventional

Funder types: NETWORK; NIH

Identifiers

NCT00031629

U10CA027469 (U.S. NIH Grant/Contract)

GOG-0131G (Other Identifier)

NCI-2012-02456 (Registry Identifier)

CDR0000069206

Details and patient eligibility

About

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.

Full 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.

Enrollment: 51 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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51 participants in 1 patient group

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

Experimental group

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.

Treatment:

Biological: Filgrastim

Drug: Docetaxel

Biological: Pegfilgrastim

Drug: Gemcitabine Hydrochloride