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SarcomaPhase 2NCT01716689

Clinical Study of Metronomic Oral Cyclophosphamide in Patients With Advanced Sarcomas

A Phase 2 study testing oral cyclophosphamide in people with Sarcoma, run by National Cancer Centre, Singapore at 1 site in Singapore.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 21 years and older
Conditions the study is for
Sarcoma
What is being tested?
oral cyclophosphamide
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
24 participants
Where
1 siteSingapore
Study dates
Jun 2012to Oct 2016
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 21 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
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  • 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:
  • Hemoglobin > 10g/dL
  • Absolute neutrophil count (ANC) > 1500/mm3
  • Platelet count > 75,000/mm3
  • Total bilirubin < 1.5 times institutional upper limits or normal (ULN)
  • AST/ALT < 3 times ULN (< 5 times ULN if hepatic involvement is present)
  • Creatinine < 1.5 times ULN. If creatinine is > 1.5 times ULN, a calculated creatinine clearance time (CCT) should be performed and patient would be eligible for study if the calculated CCT is > 10 mL/min.
  • [NB: Glomerular filtration rate (GFR) = [(140 - age) x weight [kg] x 1.22 ] / (serum creatinine [umol/L]. In women, multiply this result by 0.85
  • Resolution, or return to baseline of all clinically significant toxicities related to prior therapies
  • Patients must be suitable for oral drug administration
  • Willingness to use effective means of birth control throughout the duration of clinical study and for at least 3 months after completion of study drug
  • Women of childbearing potential must have a negative pregnancy test performed within 7 days of the start of study drug administration
  • Ability to understand and the willingness to sign a written informed consent document

Who cannot join

  • 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
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  • 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.

Trial locations and contacts

1 site in 1 country.

Singapore1 site

  • National Cancer Centre Singapore

    Singapore, Singapore, 169610

Other trials in Singapore

About this study

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

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.

Read the 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.

Conditions
Sarcoma
Being tested
oral cyclophosphamide
Medical subject headings
Sarcoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • oral cyclophosphamideDrug

    50mg daily

Study groups in NCT01716689
Study groupRoleWhat they receive
Patients with advanced sarcomaExperimentalNot described
Receives: Drug: oral cyclophosphamide

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: 24 months

Secondary outcomes (3)

  1. Assessment of objective response rate (ORR)

    Measured: 24 months

  2. Assessment of progression free survival

    Measured: 24 months

  3. Assessment on duration of response to oral metronomic cyclophosphamide in patients who exhibit objective responses

    Measured: 24 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Oct 2012 (estimated)
  2. Study startJun 2012
  3. Primary completionOct 2016
  4. Study completionOct 2016

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
24 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01716689
Sponsor's protocol ID
NCC1201
Status last verified
Mar 2017
First submitted
13 May 2012
Last updated
29 Mar 2017
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing oral cyclophosphamide in people with Sarcoma, run by National Cancer Centre, Singapore at 1 site in Singapore.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 22 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 29 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Singapore. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01716689.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Mar 2017.

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