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Clinical Trials/ISRCTN58705307
ISRCTN58705307CompletedPhase 1

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

niversity of Leicester (UK)0 sites28 target enrollmentStarted: October 28, 2011Last updated:
Conditions

Trial Snapshot

Phase
Phase 1
Status
Completed
Sponsor
Enrollment
28

Study Overview

Brief Summary

Study Design

Study Type
Interventional

Eligibility Criteria

Sex
All

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

Investigators

Sponsor
niversity of Leicester (UK)

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