Phase 2
N=19
Inhalation SLIT Cisplatin (Liposomal) for the Treatment of Osteosarcoma Metastatic to the Lung
Osteosarcoma Metastatic
Bottom Line
View on ClinicalTrials.gov: NCT00102531 ↗Enrolled (actual)
19
Serious AEs
15.8%
Results posted
Aug 2017
Primary outcome: Primary: The Study Medication Was to be Considered Effective if the Population Response Rate Was Found to be Greater Than 20% and Individuals Who Demonstrated a CR or PR or Whose Tumours Demonstrated a Grade 3 or 4 Histologic Response at the Time of Surgery. — 2; 2; 1; 1 participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Cisplatin liposomal (Drug)
- Age
- Pediatric, Adult · 13+ yrs
- Sex
- All
- Sponsor
- Insmed Incorporated
- Primary completion
- Mar 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY The Study Medication Was to be Considered Effective if the Population Response Rate Was Found to be Greater Than 20% and Individuals Who Demonstrated a CR or PR or Whose Tumours Demonstrated a Grade 3 or 4 Histologic Response at the Time of Surgery. |
2; 2; 1; 1 | — |
Summary
Phase Ib/IIa open label safety and efficacy study designed to determine the maximum tolerated dose of inhaled cisplatin liposomal (SLIT cisplatin) administered every 14 days to patients with relapsed/progressive osteosarcoma metastatic to the lung.
Eligibility Criteria
Inclusion Criteria
- Histologically proven, Progressive or recurrent high grade osteosarcoma metastatic to the lung
- Patients with histologically proven, fully malignant high-grade osteosarcoma of bone
- Measureable pulmonary metastases
- Less than grade 3 neuropathies, insignificant decreases in cardiac or auditory function
- ECOG performance status of 0, 1 or 2
- FEV1 of 50% or greater of predicted value
- FEV1/FVC ratio of 65% or greater
- Serum creatinine of ≤ 1.5 mg/dl
- Total bilirubin ≤ 1.5mg/dl and SGOT or SGPT < 2.5 times upper normal limit
- ANC of ≥ 1, 000/mm3 and platelet count of ≥ 100,000/mm3
Exclusion Criteria
- Grade 3 or higher painful neuropathy persisting after a prior platinum containing regimen
- Patients who are pregnant or are of childbearing potential and not using methods to avoid pregnancy
- Concurrent systemic chemotherapy
- Greater than Grade 2 pulmonary toxicity
- Pulmonary atelectasis
- Reactive airway disease which has resulted in hospitalization within the last year or which requires daily treatment with bronchodilator therapy
- Concurrent serious infections
- Unstable or serious concurrent medical condition
- Recent major surgery or thoracic radiation therapy or chemotherapy
- Significant pulmonary fibrosis secondary to prior radiation
- Major ventilatory distribution abnormalities
- Osteosarcoma secondary to radiation or premalignant conditions
- History of prior malignancy
- Low grade osteosarcoma, parosteal or periosteal sarcoma
Data sourced from ClinicalTrials.gov (NCT00102531). 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.