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A Phase II Evaluation of Gemcitabine (NSC #613327) and Docetaxel (NSC # 628503) in the Treatment of Recurrent or Persistent Carcinosarcoma of the Uterus

Phase 2
Not Enrolling

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Trial Information

A Phase II Evaluation of Gemcitabine (NSC #613327) and Docetaxel (NSC # 628503) in the Treatment of Recurrent or Persistent Carcinosarcoma of the Uterus


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

- 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

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)



- Any age

Performance status

- GOG 0-2

Life expectancy

- Not specified


- 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


Biologic therapy

- 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


- See Disease Characteristics

- See Biologic therapy

- 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

Endocrine therapy

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

- Concurrent hormone replacement therapy allowed


- See Disease Characteristics

- 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

Type of Study:


Study Design:

Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Frequency and duration of objective response

Safety Issue:


Principal Investigator

Brigitte E. Miller, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Comprehensive Cancer Center of Wake Forest University


United States: Federal Government

Study ID:




Start Date:

March 2005

Completion Date:

Related Keywords:

  • Sarcoma
  • uterine carcinosarcoma
  • recurrent uterine sarcoma
  • Carcinosarcoma
  • Sarcoma



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