Combining Curcumin With FOLFOX Chemotherapy in Patients With Inoperable Colorectal Cancer (CUFOX)
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| ClinicalTrials.gov Identifier: NCT01490996 |
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Recruitment Status :
Completed
First Posted : December 13, 2011
Last Update Posted : January 31, 2020
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Oral curcumin (complex C3, Sabinsa Corp, Utah) will be given to patients with inoperable colorectal metastases who will be commencing standard care oxaliplatin-based (FOLFOX) chemotherapy for up to 12 cycles(approximately 6 months) of treatment.
Primary measurements focus on safety and tolerability. These will be recorded in real-time and report the number and severity of adverse events.
Secondary measurements will include efficacy, (measured by response rate with RECIST and overall survival in months) supported by biomarker analysis.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Colonic Cancer Metastasis | Drug: Oral complex C3 curcumin + chemotherapy Drug: Chemotherapy only | Phase 1 Phase 2 |
Hypothesis Combination of oral curcumin with FOLFOX-based chemotherapy will be a safe and tolerated regimen for long-term administration to patients with colorectal metastases.
Primary objectives
To establish a tolerated dose of daily oral curcumin to be taken long-term with FOLFOX-based chemotherapy in patients with metastatic colorectal cancer will be conducted to assess:
1. Safety, tolerability and feasibility of administering oral curcumin at increasing doses escalating to 4 capsules (≈2 g C3-complex) during FOLFOX-based chemotherapy and continued for the duration of the chemotherapy course.
Secondary objectives
- To observe any changes to the neuropathic side-effects of chemotherapy.
- To observe potential for efficacy in terms of disease response and survival.
- To identify putative biomarkers in plasma.
This is a phase I/IIa study:
Phase I will be a traditional escalation response design study (or 3+3+3) to firstly assess the safety of this combination and identify a maximum tolerated dose up to 4 g per day.
Phase IIa will be a randomised control study comparing curcumin and FOLFOX with FOLFOX alone, recruited at a 2:1 ratio respectively.
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 41 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| Official Title: | A Phase I/IIa Study Combining Curcumin (Curcumin C3-Complex, Sabinsa) With Standard Care FOLFOX Chemotherapy in Patients With Inoperable Colorectal Cancer. |
| Study Start Date : | February 2012 |
| Actual Primary Completion Date : | May 31, 2017 |
| Actual Study Completion Date : | May 31, 2017 |
| Arm | Intervention/treatment |
|---|---|
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Active Comparator: Chemotherapy only
Patients receiving up to 12 cycles of therapy. Standard care pathway management.
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Drug: Chemotherapy only
Standard care chemotherapy
Other Name: FOLFOX (protocol includes changes to XELOX - capecitabine) |
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Experimental: Chemotherapy plus curcumin
Patients taking daily oral curcumin for up to 12 cycles of therapy. Standard care pathway management.
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Drug: Oral complex C3 curcumin + chemotherapy
Daily oral capsule(s)
Other Name: C3-complex curcumin (diferuloylmethane) |
- Completion of dose escalation over 2 cycles of therapy [ Time Frame: 1 year ]Patients will start curcumin a week prior to chemotherapy. Upon completion of two cycles of therapy without dose-limiting toxicity in 3 consecutive patients, the dose will be escalated for the next 3 patients. Real-time adverse event reporting will be undertaken to record number and severity of events.
- Completion of (or withdrawal from) chemotherapy [ Time Frame: Up to 6 months ]Compliance in the study will be measured in months/cycles of therapy tolerated. Reasons for withdrawal or cessation will be documented which will include mortality, adverse events and patient reported outcomes of tolerance to the protocol regimen.
- Efficacy in terms of disease response and survival [ Time Frame: Up to 7 years ]Response rate will be measured using RECIST. Overall survival will be measured in months.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Histological or cytological diagnosis of metastatic colorectal cancer
- Measurable disease by Response Evaluation Criteria in Solid Tumours version 1.1 (RECIST 1.1) (Appendix 1)
- Adequate haematological, hepatic and renal function
- Age ≥ 18 years
- Eastern Cooperative Oncology Group (ECOG) Performance status 0 or 1
- Patients must have recovered from effects of any recent major surgery
- Willing to use contraception if applicable
- Informed consent
- Life expectancy estimated to be more than 12 weeks
Exclusion Criteria:
- Main exclusion criteria
- Contraindications to FOLFOX chemotherapy: Peripheral neuropathy NCI CTC >1, Liver failure, uncontrolled coronary heart disease, myocardial infarction within the previous 6 months.
- Unwilling or unable to comply with the study protocol.
- 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.
- Undergone chemotherapy (other than adjuvant for CRC) or participating in another drug study.
- Previous cancer <5 years (other than colorectal, basal cell carcinoma, in-situ cervical cancer).
- Major surgery within 4 weeks of starting the study
- Co-existing active infection or serious concurrent medical condition
- Significant cardiovascular disease
- Bone metastases
- Known brain or leptomeningeal metastases
- Surgery or hospital admissions for symptomatic intra-abdominal adhesions
- Active endoscopically proven peptic ulcer disease or colitis
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01490996
| United Kingdom | |
| Dept Oncology, Leicester Royal Infirmary | |
| Leicester, United Kingdom, LE1 2WW | |
| Principal Investigator: | Anne L Thomas, PhD FRCS | University of Leicester/University Hospitals Leicester |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | University of Leicester |
| ClinicalTrials.gov Identifier: | NCT01490996 |
| Other Study ID Numbers: |
0225 |
| First Posted: | December 13, 2011 Key Record Dates |
| Last Update Posted: | January 31, 2020 |
| Last Verified: | May 2017 |
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Curcumin Colorectal cancer metastases FOLFOX |
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Colorectal Neoplasms Neoplasm Metastasis Colonic Neoplasms Intestinal Neoplasms Gastrointestinal Neoplasms Digestive System Neoplasms Neoplasms by Site Neoplasms Digestive System Diseases Gastrointestinal Diseases Colonic Diseases Intestinal Diseases Rectal Diseases Neoplastic Processes Pathologic Processes |
Curcumin Capecitabine Antimetabolites, Antineoplastic Antimetabolites Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Anti-Inflammatory Agents, Non-Steroidal Analgesics, Non-Narcotic Analgesics Sensory System Agents Peripheral Nervous System Agents Physiological Effects of Drugs Anti-Inflammatory Agents Antirheumatic Agents Enzyme Inhibitors |