Clinical trial · Interventional
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
NCT00031629CI-TRIAL-00025082completedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Recurrent Uterine Corpus Sarcoma | Uterine Corpus Sarcoma | CURATED_BROADER | 0.78 |
| Uterine Corpus Leiomyosarcoma | Uterine Corpus Leiomyosarcoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Docetaxel | Drug | Docetaxel | ALIAS |
| Filgrastim | Biological | Filgrastim | ALIAS |
| Gemcitabine Hydrochloride | Drug | Gemcitabine | ALIAS |
| Pegfilgrastim | Biological | Pegfilgrastim | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Treatment (gemcitabine, docetaxel, G-CSF, pegfilgrastim)
- 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.
- interventionNames
- Drug: Docetaxel
- Biological: Filgrastim
- Drug: Gemcitabine Hydrochloride
- Biological: Pegfilgrastim
Primary outcomes (2)
- measure
- Frequency and duration of objective response
- timeFrame
- Up to 5 years
- measure
- Frequency of severity of observed adverse effects assessed using CTC version 2.0
- timeFrame
- Up to 5 years
- description
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.