Capecitabine and oral cyclophosphamide - a novel oral treatment combination for advanced cancer

Phase I/II study to find the maximum tolerable dose of the combination of capecitabine and oral cyclophosphamide in the treatment of advanced cancer

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12605000375651

Acronym

Cyclox I

Enrollment

Registered

2005-09-13

Start date

2000-07-18

Completion date

Unknown

Last updated

2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Oral cyclophosphamide days 1-14, plus capecitabine days 1-28 of 28 day treatment cycle.

Study design

Allocation

Non-randomised trial

Intervention model

Other

Primary purpose

Treatment

Masking

Open (masking not used)

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

Histological / cytological evidence of carcinoma; performance status (WHO) 0-2; adequate bone marrow, renal and hepatic function;recovery from prior chemotherapy toxicity and calculated creatine clearance >50ml/min.

Exclusion criteria

Lack of physical integrity of upper GI tract; more than 2 prior courses of chemotherapy; prior pelvic radiation; pregnant or lactating; investigational drug within 4 weeks; history of clinically significant cardiac disease or MI in past 12 months.

Outcome results