A phase I/IIa study combining curcumin (Curcumin C3 Complex, Sabinsa) with standard care FOLFOX chemotherapy in patients with inoperable colorectal cancer

Phase 1

Completed

• Conditions: Topic: National Cancer Research Network; Subtopic: Colorectal Cancer; Disease: Colon; Cancer; Malignant neoplasm of colon and rectum

• Registration Number: ISRCTN58705307
• Lead Sponsor: niversity of Leicester (UK)

Brief Summary

2015 protocol in https://www.ncbi.nlm.nih.gov/pubmed/25872567 2019 results in: https://www.ncbi.nlm.nih.gov/pubmed/31132111 (added 04/09/2019)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2011-10-28
• Study Completion: 2015-01-09
• Last Update Posted: 7 October 2019

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 28

Inclusion Criteria

1. Histological or cytological diagnosis of metastatic colorectal cancer
2. Measurable disease by Response Evaluation Criteria in Solid Tumours version 1.1 (RECIST 1.1)
3. Adequate haematological, hepatic and renal function
4. Age more than or equal to 18 years
5. Eastern Cooperative Oncology Group (ECOG) Performance status 0 or 1
6. Patients must have recovered from effects of any recent major surgery
7. Willing to use contraception if applicable
8. Informed consent
9. Life expectancy estimated to be more than 12 weeks; Target Gender: Male & Female ; Lower Age Limit 18 no age limit or unit specified

Exclusion Criteria

1.Contraindications to FOLFOX chemotherapy: Peripheral neuropathy National Cancer Institute Common Toxicity Criteria (NCI CTC) >1, Liver failure, uncontrolled coronary heart disease, myocardial infarction within the previous 6 months.
2. Unwilling or unable to comply with the study protocol
3. Patients who are pregnant or lactating or contemplating pregnancy. Patients or their partners who become pregnant during the study will be referred to the appropriate experts.
4. Undergone chemotherapy (other than adjuvant for CRC) or participating in another drug study.
5. Previous cancer <5 years (other than colorectal, basal cell carcinoma, in-situ cervical cancer)
6. Major surgery within 4 weeks of starting the study
7. Co-existing active infection or serious concurrent medical condition
8. Significant cardiovascular disease
9. Bone metastases
10. Known brain or leptomeningeal metastases
11. Surgery or hospital admissions for symptomatic intra-abdominal adhesions
12. Active endoscopically proven peptic ulcer disease or colitis

Study & Design

• Study Type: Interventional
• Study Design: Not specified