Phase 2
N=49
A Phase II Study of Oral Cyclophosphamide and Sirolimus (OCR) in Advanced Sarcoma
Osteosarcoma
Bottom Line
View on ClinicalTrials.gov: NCT00743509 ↗Enrolled (actual)
49
Serious AEs
34.7%
Results posted
May 2013
Primary outcome: Primary: Number of Patients Alive Without Disease Progression — 10 participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Cyclophosphamide and Sirolimus (Drug)
- Age
- Pediatric, Adult, Older Adult · 16+ yrs
- Sex
- All
- Sponsor
- University of Michigan Rogel Cancer Center
- Primary completion
- Apr 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Patients Alive Without Disease Progression |
10 | — |
| SECONDARY Median Overall Survival Time |
298 | — |
Summary
The purpose of this Phase II study will assess the effectiveness of the combination of oral cyclophosphamide and sirolimus in sarcoma patients with relapsed or widespread disease who cannot be cured by surgery, radiation or conventional chemotherapy.
Eligibility Criteria
Inclusion Criteria
- Progressive or recurrent, advanced (unresectable or metastatic) high-grade osteosarcoma, Ewing's or soft tissue sarcoma previously treated with chemotherapy.
- Bi-dimensionally measurable lesion(s) on cross-sectional radiography, such as computed tomography or magnetic resonance imaging, within 2 weeks of enrollment.
- ECOG/Zubrod performance score 0, 1 or 2.
- Total WBC >3, 000, neutrophil count >1,000, platelet count >100,000 within 2 weeks of enrollment.
- Serum creatinine 16 years of age at the time the consent document is signed by the patient.
- A paraffin block containing sarcoma, either from a previous surgery or recent biopsy, must be available for correlative studies. If a paraffin block containing sarcoma is not available, patients are required to undergo biopsy to obtain tissue for the correlative studies.
Exclusion Criteria
- Active infection requiring antibiotic treatment.
- Diabetes mellitus not under good control (e.g. hemoglobin A1c > 8% or fasting glucose > 180 mg/dl) with oral agents or insulin.
- Prior treatment with mTOR inhibitor for sarcoma.
- Less than 3 weeks from prior treatment with chemotherapy to start of treatment with cyclophosphamide and sirolimus. Toxicities from prior chemotherapy (except alopecia) should be grade 1 or less before starting treatment with cyclophosphamide and sirolimus.
- Prior radiation less than two weeks since the administration of the last fraction of radiation therapy to the start of treatment. Patients must have recovered from grade 2 or higher radiation-associated toxicities to be eligible. All measurable lesions, which are being targeted, must be outside previously radiated fields or have documented progression at least 6 weeks after completion of radiation.
- Untreated or active CNS involvement by sarcoma.
- Active second malignancy other than carcinoma in situ. Patients with malignancy other than sarcoma in remission are eligible.
- Women who are pregnant or breastfeeding.
Data sourced from ClinicalTrials.gov (NCT00743509). 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.