Gemcitabine and Docetaxel in Treating Patients With Recurrent or Persistent Uterine Cancer

Gynecologic Oncology Group (GOG)

Status and phase: Completed; Phase 2

Conditions: Uterine Carcinosarcoma; Recurrent Uterine Corpus Sarcoma

Treatments: Drug: Docetaxel; Drug: Gemcitabine Hydrochloride

Study type: Interventional

Funder types: NETWORK; NIH

Identifiers

NCT00114218

U10CA027469 (U.S. NIH Grant/Contract)

CDR0000434843

GOG-0130E (Other Identifier)

NCI-2012-02680 (Registry Identifier)

Details and patient eligibility

About

This phase II trial is studying how well giving gemcitabine together with docetaxel works in treating patients with recurrent or persistent uterine cancer. Drugs used in chemotherapy, such as gemcitabine and docetaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells.

Full description

OBJECTIVES:

I. Determine the antitumor activity of gemcitabine and docetaxel in patients with recurrent or persistent uterine carcinosarcoma.

II. Determine the nature and degree of toxicity of this regimen in these patients.

OUTLINE: This is a non-randomized, multicenter study. Patients receive gemcitabine IV over 30 minutes followed by docetaxel IV over 1 hour on days 1, 8, and 15. Courses repeat every 28 days in the absence of unacceptable toxicity or disease progression.

After completion of study treatment, patients are followed every 3 months for 2 years and then every 6 months for 3 years.

PROJECTED ACCRUAL: A total of 22-60 patients will be accrued for this study within 1-4 years.

Enrollment: 28 patients

Sex: Female

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

• Histologically confirmed uterine carcinosarcoma

  • Malignant mixed Müllerian tumor, homologous or heterologous type

  • Recurrent or persistent disease

    • Progressive disease after prior local therapy

• Measurable disease, defined as ≥ 1 unidimensionally measurable lesion ≥ 20 mm by conventional techniques OR ≥ 10 mm by spiral CT scan

  • At least 1 target lesion
  • Tumors within a previously irradiated field are not considered target lesions except documented progression or biopsy to confirm persistence at least 90 days after completion of radiation therapy

• Received 1, and only 1, prior chemotherapy regimen for carcinosarcoma

  • Initial treatment may have included high-dose therapy, consolidation, or extended therapy administered after surgical or non-surgical assessment

• Ineligible for higher priority GOG protocol (i.e., any active phase III GOG protocol for the same patient population)

• Performance status - GOG 0-2

• Absolute neutrophil count ≥ 1,500/mm^3

• Platelet count ≥ 100,000/mm^3

• Bilirubin ≤ 1.5 times upper limit normal (ULN)

• SGOT ≤ 2.5 times ULN

• Alkaline phosphatase ≤ 2.5 times ULN

• Creatinine ≤ 1.5 times ULN

• No severe pulmonary disease requiring oxygen supplementation

• Not pregnant or nursing

• Negative pregnancy test

• Fertile patients must use effective contraception

• No active infection requiring antibiotics

• No other invasive malignancy within the past 5 years except nonmelanoma skin cancer

• No neuropathy (sensory or motor) > grade 1

• At least 3 weeks since prior biologic therapy or immunotherapy for the malignancy

• No more than 1 prior non-cytotoxic (biologic or cytostatic) regimen (e.g., monoclonal antibodies, cytokines, or small molecule inhibitors of signal transduction) for recurrent or persistent disease

• Recovered from prior chemotherapy

• No more than 1 prior cytotoxic chemotherapy regimen, either as a single agent or combination therapy

• No prior docetaxel or gemcitabine

• At least 1 week since prior hormonal therapy for the malignancy

• Concurrent hormone replacement therapy allowed

• Recovered from prior radiotherapy

• Recovered from prior surgery

• At least 3 weeks since other prior therapy for the malignancy

• No prior cancer treatment that would preclude study therapy

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

28 participants in 1 patient group

Treatment (gemcitabine hydrochloride, docetaxel)

Experimental group

Description:

Patients receive gemcitabine IV over 30 minutes followed by docetaxel IV over 1 hour on days 1, 8, and 15. Courses repeat every 28 days in the absence of unacceptable toxicity or disease progression.

Treatment:

Drug: Gemcitabine Hydrochloride

Drug: Docetaxel