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

Phase 1

Completed

• Conditions: Advanced Cancer; Cancer -

• Registration Number: ACTRN12605000375651
• Lead Sponsor: Dr Michael Findlay

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2005-09-13
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 40

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Dose limiting toxicities[Assessed over the first 8 weeks of treatment]

Secondary Outcome Measures

Name	Time	Method
Steady state plasma levels[Over first 8 weeks of treatment];Develop quality of life questionnaire[Duration of study];Determine efficacy[Best tumour response assessed 8 weekly through out study];Patients are treated until disease progression, unacceptable toxicity or patient/physician decision to withdraw.[]