Clinical trial · Interventional
Paclitaxel and Carboplatin in Treating Patients With Persistent or Recurrent Stage III or Stage IV Uterine Cancer
A Phase II Evaluation of Paclitaxel (Taxol, NSC # 673089) and Carboplatin (Paraplatin, NSC #241240) in the Treatment of Advanced, Persistent, or Recurrent Uterine Carcinosarcoma
- 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)
RATIONALE: Drugs used in chemotherapy, such as paclitaxel and carboplatin, 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. PURPOSE: This phase II trial is studying how well giving paclitaxel together with carboplatin works in treating patients with persistent or recurrent stage III or stage IV uterine cancer.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Sarcoma | Sarcoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| carboplatin | Drug | Carboplatin | ALIAS |
| paclitaxel | Drug | Paclitaxel | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Taxol-Carbo
- description
- Paclitaxel 175 mg/m2 IV over 3 hours followed by carboplatin AUC = 6 IV over 30 minutes every 21 days until disease progression or adverse effects prohibit further therapy
- interventionNames
- Drug: carboplatin
- Drug: paclitaxel
Primary outcomes (2)
- measure
- Nature and Degree of Toxicity
- timeFrame
- During study treatment and up to 30 days after stopping study treatment
- description
- Number of patients who experienced grade 1 or higher serious adverse event (term or group) regardless of attribution using CTCAE v3.0
- measure
- Response Evaluation Criteria in Solid Tumors Criteria (RECIST) 1.0 Best Response
- timeFrame
- Response was measured every other cycle (q 6 weeks) until disease progression is documented.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 120 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS:
* Histologically confirmed uterine carcinosarcoma (mixed mesodermal tumor)
* Stage III or IV disease
* Persistent or recurrent disease
* Documented disease progression
* 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 unless there is documented disease progression
* Ineligible for any higher priority Gynecology Oncology Group (GOG) protocol (i.e., any active GOG phase III protocol for the same patient population)
PATIENT CHARACTERISTICS:
Age
* 18 and over
Performance status
* GOG 0-2
Life expectancy
* Not specified
Hematopoietic
* Platelet count ≥ 100,000/mm\^3
* Absolute neutrophil count ≥ 1,500/mm\^3
Hepatic
* Bilirubin ≤ 1.5 times upper limit of normal (ULN)
* SGOT ≤ 2.5 times ULN
* Alkaline phosphatase ≤ 2.5 times ULN
Renal
* Creatinine ≤ 1.5 times ULN
Other
* 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 sensory or motor neuropathy \> grade 1
PRIOR CONCURRENT THERAPY:
Biologic therapy
* Not specified
Chemotherapy
* No prior cytotoxic chemotherapy for uterine sarcoma
Endocrine therapy
* At least 1 week since prior hormonal therapy for uterine sarcoma
* Concurrent hormone replacement therapy allowed
Radiotherapy
* See Disease Characteristics
Surgery
* Not specified
Other
* Recovered from all prior therapy
* No prior anticancer therapy that would preclude study therapyReferences
Publications (1)
- RESULTPowell MA, Filiaci VL, Rose PG, Mannel RS, Hanjani P, Degeest K, Miller BE, Susumu N, Ueland FR. Phase II evaluation of paclitaxel and carboplatin in the treatment of carcinosarcoma of the uterus: a Gynecologic Oncology Group study. J Clin Oncol. 2010 Jun 1;28(16):2727-31. doi: 10.1200/JCO.2009.26.8326. Epub 2010 Apr 26. PMID 20421537