Symptoms and General Pathology

All Conditions

Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Rare Diseases

Recurrence

Sarcoma

Uterine Neoplasms

Carcinosarcoma

Mixed Tumor, Mullerian

Adenoma, Pleomorphic

Disease Attributes

Neoplasms, Connective and Soft Tissue

Neoplasms by Histologic Type

Soft Tissue Sarcoma

Malignant Mixed Mullerian Tumor

Uterine Sarcoma

Uterine Carcinosarcoma

Antineoplastic Agents

All Drugs and Chemicals

Gemcitabine

Docetaxel

Antimetabolites

Tubulin Modulators

Antimitotic Agents

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.

Gemcitabine Hydrochloride

Brigitte Miller

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.

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.

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

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

RECIST 1.0 defines complete response as the disappearance of all target lesions and non-target lesions and no evidence of new lesions documented by two disease assessments at least 4 weeks apart. Partial response is defined as at least a 30% decrease in the sum of longest dimensions (LD) of all target measurable lesions taking as reference the baseline sum of LD. There can be no unequivocal progression of non-target lesions and no new lesions. Documentation by two disease assessments at least 4 weeks apart is required. In the case where the ONLY target lesion is a solitary pelvic mass measured by physical exam, which is not radiographically measurable, a 50% decrease in the LD is required. These patients will have their response classified according to the definitions stated above. Complete and partial responses are included in the objective tumor response rate.

Count of participants with Toxicities maximum grade greater than or equal to grade 3

National Cancer Institute (NCI)

Gynecologic Oncology Group

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.

Gemcitabine Hydrochloride: Given IV

Docetaxel: Given IV

Treatment (Gemcitabine Hydrochloride, Docetaxel)

<50 years

50-59 years

60-69 years

70-79 years

>79 years

Age, Customized

Sex: Female, Male

Linda Gedeon for Austin Miller, PhD.

Percentage of Patients With Objective Tumor Response Rate (Either Complete Response (CR) or Partial Response (PR) Using RECIST Version 1.0

Incidence of Adverse Effects That Are Grade 3 or Greater as Assessed by Common Terminology Criteria for Adverse Events Version 3.0

Overall Study

Spots Global Cancer Trial Database for Gemcitabine and Docetaxel in Treating Patients With Recurrent or Persistent Uterine Cancer

Trial Identification

Conditions

Interventions

Study Description

Keywords

Eligibility

Locations

Contact Details

Useful links and downloads for this trial