Phase 2
N=46
Carboplatin Combined With Paclitaxel in Treating Patients With Advanced Thymoma
Thymoma · Thymic Carcinoma
Bottom Line
View on ClinicalTrials.gov: NCT00010257 ↗Enrolled (actual)
46
Serious AEs
60.0%
Results posted
Oct 2012
Primary outcome: Primary: Best Overall Response by RECIST Criteria (Version 1.0) — 3; 0; 5; 6 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- carboplatin (Drug); paclitaxel (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Eastern Cooperative Oncology Group
- Primary completion
- Nov 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Best Overall Response by RECIST Criteria (Version 1.0) |
3; 0; 5; 6; 13; 8 | — |
| SECONDARY Duration of Response |
16.9; 5.0 | — |
Summary
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one chemotherapy drug may kill more tumor cells.
PURPOSE: Phase II trial to study the effectiveness of carboplatin combined with paclitaxel in treating patients who have advanced thymoma.
Eligibility Criteria
Inclusion Criteria
- Histologically confirmed invasive, recurrent, or metastatic thymoma or thymic carcinoma not amenable to potentially curative therapy by surgery
- Extensive disease (distant disease, pleural disease, pulmonary with or without mediastinal disease, or recurrent progressive disease in site of prior radiotherapy)
- Advanced limited disease allowed if ineligible for primary radiotherapy or surgery
- Measurable disease
- Age 18 and over
- ECOG Performance Status 0-1
- Granulocyte count at least 1,500 cells/mm^3
- Platelet count at least 100,000 cells/mm^3
- Bilirubin no greater than 1.5 mg/dL
- Creatinine no greater than 2.0 mg/dL
- Concurrent corticosteroids for myasthenia gravis or other chronic conditions allowed
Exclusion Criteria
- Acute concurrent complications such as infection or post-surgical complications
- Other prior malignancy within the past 5 years unless curatively treated with no evidence of recurrence
- Pregnant or nursing. A negative pregnancy test was required, and fertile patients must use effective contraception
- Prior chemotherapy for metastatic disease. Prior preoperative or adjuvant chemotherapy allowed if disease-free survival prior to recurrence was more than 1 year
Data sourced from ClinicalTrials.gov (NCT00010257). 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.