A phase II study of oxaliplatin/5-FU/Avastin and concurrent radiation in patients with simultaneous primary and metastatic rectal cancer

Phase 2

Active, not recruiting

• Conditions: Primary rectal cancer; Metastatic rectal cancer; Cancer - Bowel - Back passage (rectum) or large bowel (colon)

• Registration Number: ACTRN12611000033943
• Lead Sponsor: Peter MacCallum Cancer Centre

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2011-01-10
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Active, not recruiting
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

1. Patients with previously untreated and pathologically proven adenocarcinoma of the rectum with distant metastasis who would benefit from combined local therapy and systemic chemotherapy.
2. Lower border of tumour must be within 15cm of anal verge.
3. Age >= 18 years.
4. Absolute neutrophil count >= 1.5 x 10^9/L, haemoglobin >= 90 g/L, platelet count >=100 x 10^9/L
5. ECOG performance status of <= 2
6. Adequate renal function: GFR >= 55 ml/min (using radioisotope renal scan or derived from serum creatinine using the Cockcroft-Gault formula).
7. Adequate hepatic function with serum total bilirubin < 1.5 x upper limit of normal range, ALT/AST < 2.5 x UNL in the absence of liver metastases, or < 5 x UNL in the presence of liver metastases, ALP < 2.5 x UNL in the absence of liver metastases, or < 5 x UNL in the presence of liver metastases
8. No symptomatic peripheral neuropathy >= grade 2.
9. Males or non-pregnant, non-lactating females. Female patients of childbearing potential, not surgically sterilized, must take adequate contraceptive measures.
10. Has provided written informed consent for participation in this trial

Exclusion Criteria

1. Prior pelvic radiotherapy
2. Febrile intercurrent illness or infection.
3. Previous history of unstable angina
4. Cardiac arrhythmia which in the opinion of the investigator would compromise the safe delivery of protocol treatment
5. Acute coronary syndrome even if controlled with medication
6. Myocardial infarction within the last 12 months
7. Concurrent treatment with other anti-cancer therapy.
8. No medical co-morbidities that have the potential to be exacerbated by or contra-indicate therapy
a. Uncontrolled hypertension
b. Active bleeding disorders within the last 3 months
c. Patients with NYHA Grade III/IV cardiac problems (e.g. congestive heart failure, or myocardial infarction or active myocardial ischemia within 12 months of study)
d. Patients with active liver disease (e.g., chronic active hepatitis, cirrhosis).
e. Patients with a known diagnosis of human immunodeficiency virus (HIV) infection.
f. Patients who have had major surgery within 28 days prior to commencing study drugs
g. Patients with a serious non-healing wound, ulcer or bone fracture

9. Significant medical condition which in the opinion of the investigator would compromise the planned delivery of the chemotherapy and radiotherapy or which may be potentially exacerbated by these modalities.
10. Locally recurrent rectal cancer
11. Female patients who are pregnant or breast-feeding
12. Medical or psychiatric conditions that compromises the patient's ability to give informed consent or to complete the protocol, or a history of non-compliance

Study & Design

• Study Type: Interventional
• Study Design: Not specified