Phase 2
N=34
Pazopanib in Treating Patients With Malignant Pleural Mesothelioma
Advanced Malignant Mesothelioma · Localized Malignant Mesothelioma · Recurrent Malignant Mesothelioma
Bottom Line
View on ClinicalTrials.gov: NCT00459862 ↗Enrolled (actual)
34
Serious AEs
38.2%
Results posted
Dec 2013
Primary outcome: Primary: Proportion of Evaluable Participants Who Are Progression-free at 6 Months Based on the Response Evaluation Criteria for Solid Tumors (RECIST) — 47.8 percentage of participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- laboratory biomarker analysis (Other); pazopanib hydrochloride (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- National Cancer Institute (NCI)
- Primary completion
- Apr 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Proportion of Evaluable Participants Who Are Progression-free at 6 Months Based on the Response Evaluation Criteria for Solid Tumors (RECIST) |
47.8 | — |
| SECONDARY Overall Survival |
11.5 | — |
| SECONDARY Progression-free Survival Assessed by RECIST |
4.2 | — |
| SECONDARY Determine the Clinical Toxicities of This Drug in This Participant Population. |
23; 5; 3 | — |
| SECONDARY Overall Best Response of Target Lesions to Pazopanib in Patients With MPM Based on the RECIST. |
5; 0 | — |
| SECONDARY Overall Response Rate |
5.9 | — |
Summary
This phase II trial is studying the side effects and how well pazopanib works in treating patients with malignant pleural mesothelioma. Pazopanib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor.
Eligibility Criteria
Inclusion Criteria
- Histologically or cytologically confirmed malignant pleural mesothelioma:
- Measurable disease
- No progressive disease inside or outside of any prior radiation field
- No symptomatic, untreated, or uncontrolled CNS metastases
- Patients with CNS metastases treated with whole brain radiation (WBRT) may be enrolled after completion of WBRT
- Patients may begin study therapy as early as the next day after completion of WBRT
- ECOG performance status 0-2
- Life expectancy >= 12 weeks
- ANC >=1,500/mm^3
- Platelet count >= 100,000/mm^3
- WBC >= 3,000/mm^3
- Bilirubin = = 50 mL/min
- Proteinuria = = 1 week apart
- No condition that impairs ability to swallow and retain study drug tablets including, but not limited to, any of the following:
- Gastrointestinal tract disease resulting in an inability to take oral medication
- Requirement for IV alimentation
- Prior surgical procedures affecting absorption
- Active peptic ulcer disease
- No other primary malignancy except for carcinoma in situ of the cervix or nonmelanomatous skin cancer, unless that prior malignancy was diagnosed and definitively treated ≥ 5 years ago with no subsequent evidence of recurrence
- Patients with a history of low-grade (Gleason score = 140 mm Hg and/or diastolic BP > 90 mm Hg in spite of adequate anti-hypertensive therapy)
- No other severe underlying disease that, in the judgment of the investigator, would limit study compliance
Data sourced from ClinicalTrials.gov (NCT00459862). 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.