Phase 2
N=55
Paclitaxel and Carboplatin in Treating Patients With Persistent or Recurrent Stage III or Stage IV Uterine Cancer
Sarcoma
Bottom Line
View on ClinicalTrials.gov: NCT00112489 ↗Enrolled (actual)
55
Serious AEs
23.9%
Results posted
May 2014
Primary outcome: Primary: Nature and Degree of Toxicity — 2; 4; 20; 19 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- carboplatin (Drug); paclitaxel (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- Gynecologic Oncology Group
- Primary completion
- Jul 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Nature and Degree of Toxicity |
2; 4; 20; 19; 1; 0 | — |
| PRIMARY Response Evaluation Criteria in Solid Tumors Criteria (RECIST) 1.0 Best Response |
6; 19; 11; 6; 4 | — |
Summary
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.
Eligibility Criteria
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 therapy
Data sourced from ClinicalTrials.gov (NCT00112489). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.