Phase II Clinical Study of Metronomic Oral Cyclophosphamide in Elderly and/or Pre-treated Patients With Advanced Sarcomas

National Cancer Centre, Singapore1 site in 1 country24 target enrollmentJune 2012

ConditionsSarcoma

Interventionsoral cyclophosphamide

Overview

Phase: Phase 2
Intervention: oral cyclophosphamide
Conditions: Sarcoma
Sponsor: National Cancer Centre, Singapore
Enrollment: 24
Locations: 1
Primary Endpoint: Clinical benefit as defined by the composite of complete response (CR), partial response (PR) and stable disease (SD) lasting > 12 weeks per RECIST 1.1 as a measure of disease control
Status: Completed
Last Updated: 9 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

This is a single arm phase II clinical study to evaluate the efficacy and safety of metronomic oral cyclophosphamide in elderly and/or pre-treated patients with advanced sarcomas.

Detailed Description

Eligible patients will receive continuous metronomic oral cyclophosphamide at a dose of 50mg daily. Tumor assessments will be performed at baseline and every 6 weeks thereafter to assess response and disease progression. Toxicity will be monitored throughout treatment. The study's primary end point is defined as clinical benefit rate (CBR) at 12 weeks as a measure of disease control. The study is designed to distinguish a favorable true PFR of 40% from a null rate of 20% \[Van Glabbeke et al. EJC 2002\]. With a CBR of 40%, metronomic oral cyclophosphamide at this dose and schedule in this patient population will be considered worthy of further evaluation.

Registry

clinicaltrials.gov

Start Date

June 2012

End Date

October 2016

Last Updated

9 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

National Cancer Centre, Singapore

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Participants must meet the following criteria on screening examination to be eligible to participate in the study:
•Participants must have histologically or cytologically confirmed, metastatic and/or unresectable high grade sarcoma for which standard multi-modality curative therapies do not exist or are no longer effective. Patients with low grade sarcoma need to additionally demonstrate disease progression in the last 6 months prior to study entry.
•Age \> 21 years
•Prior anti-sarcoma chemotherapy
•Participants who are 21 to 64 years of age at the time of study entry must have received at least one line of established chemotherapy, if such treatment exists; or refused such treatment, which includes either an anthracycline and/or ifosfamide. Patients whose sarcomas do not have known established therapy are eligible for this study without the requirement of a prior therapy.
•Participants \> 65 years of age at the time of study entry are eligible for this study without the requirement for prior treatment
•ECOG performance status 0-3 (see Annex A)
•Measurable disease outside of a prior irradiated area as defined by RECIST 1.1 guidelines. A lesion in a previously irradiated area is not eligible for measurable disease unless there is objective evidence of progression of the lesion prior to study enrollment
•No limit to number of prior chemotherapies or biologics
•Participants must have normal organ function as defined below:

Exclusion Criteria

•Participants who exhibit any of the following conditions at screening will not be eligible for admission into the study.
•Patients diagnosed with gastrointestinal stromal tumor (GIST)
•Participants who have had systemic anti-cancer therapy within 3 weeks of study entry (8 weeks for nitrosoureas or mitomycin C)
•Palliative radiotherapy or major surgery within 3 weeks of study entry
•Concurrent use of any other anti-cancer therapies or study agents
•Symptomatic or uncontrolled brain or central nervous system metastases
•Participants may not be receiving any other concomitant investigational agents
•Uncontrolled intercurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
•Individuals with a history of a different malignancy, other than cervical cancer in situ, basal cell or squamous cell carcinoma of the skin, are ineligible, except if they have been disease-free for at least 5 years, and are deemed by the investigator to be at low risk for recurrence of that malignancy OR other primary malignancy is neither currently clinically significant nor requiring active intervention.

Arms & Interventions

Patients with advanced sarcoma

Intervention: oral cyclophosphamide

Outcomes

Primary Outcomes

Clinical benefit as defined by the composite of complete response (CR), partial response (PR) and stable disease (SD) lasting > 12 weeks per RECIST 1.1 as a measure of disease control

Time Frame: 24 months

Secondary Outcomes

Assessment of progression free survival(24 months)
Assessment of objective response rate (ORR)(24 months)
Assessment on duration of response to oral metronomic cyclophosphamide in patients who exhibit objective responses(24 months)