Phase 2
N=40
Sorafenib + mFOLFOX for Hepatocellular Carcinoma
Hepatocellular Cancer
Bottom Line
View on ClinicalTrials.gov: NCT01775501 ↗Enrolled (actual)
40
Serious AEs
80.0%
Results posted
Apr 2020
Primary outcome: Primary: Time to Progression — 7.7 Months
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Leucovorin (Drug); Fluorouracil (Drug); Oxaliplatin (Drug); Sorafenib (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Massachusetts General Hospital
- Primary completion
- Jul 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Time to Progression |
7.7 | — |
| SECONDARY Number of Patients Experiencing Adverse Events |
40 | — |
| SECONDARY Overall Response Rate |
7 | — |
| SECONDARY Median Progression Free Survival |
232 | — |
| SECONDARY Median Overall Survival |
15.1 | — |
| SECONDARY Duration of Response |
172 | — |
Summary
This research study is a Phase II clinical trial. Phase II clinical trials test the effectiveness of an investigational combination of drugs to learn whether the drug combination works in treating a specific cancer. "Investigational" means that the modified FOLFOX and sorafenib combination is still being studied and that research doctors are trying find out more about it-such as the safest dose to use, the side effects it may cause, and if the combination is effective for treating different types of cancer. It also means that the FDA has not yet approved the modified FOLFOX and sorafenib combination that will be used in this study for liver cancer.
FOLFOX is a combination of three drugs: folinic acid (leucovorin), fluorouracil (5-FU), and oxaliplatin. The dosage amounts for some of these FDA approved drugs will be modified slightly in this study. The FOLFOX combination is approved by the FDA and is a standard treatment of colorectal cancer. However, it is not approved for the treatment of liver cancer.
Sorafenib is a new drug, which is approved under the brand name Nexavar for the treatment of liver cancer. It is also currently being tested in various other cancers. Sorafenib works by slowing down and/or stopping the development of new cancer cells and new blood vessels. By slowing down and/or stopping the growth of new blood vessels around a tumor, it is believed that sorafenib prevents or slows down the growth of tumors.
In this research study, sorafenib, the standard treatment, is being combined with modified FOLFOX, which has shown some antitumor activity in liver cancer.
Eligibility Criteria
Inclusion Criteria
- Histologically confirmed advanced HCC
- Barcelona Clinic Liver Cancer stage C or stage B if you cannot tolerate or failed TACE
- No cirrhosis or Child-Pugh A cirrhosis
- Measurable lesions
- All acute toxic effects of any prior treatment have resolved to NCI-CTCAE v4.0 grade 1 or less
- Able to swallow and retain oral medication
Exclusion Criteria
- Prior systemic regimens for HCC
- Uncontrolled hypertension
- CLIP score > 3
- ECOG PS > 1
- Clinically apparent central nervous system metastases or carcinomatous meningitis
- Pregnant or breastfeeding
- Active or clinically significant cardiac disease
- Evidence or history of bleeding diathesis or coagulopathy
- Any pulmonary hemorrhage/bleeding event of NCI-CTCAE v4.0 Grade 2 or higher within 4 weeks of enrollment
- Presence of a non-healing wound, non-healing ulcer, or bone fracture
- History of organ allograft
- Any malabsorption condition
- Medical or psychiatric condition that constitutes an unacceptable risk for participation in this trial
- Have received another investigational agent within 4 weeks of first dose of sorafenib
- Previously untreated or concurrent cancer except those treated more than 3 years ago
- History of other disease, metabolic dysfunction, physical examination finding or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug or that might affect the interpretation of the results of the study or render the subject at high risk from treatment complications
- QTC>500msec or history of uncontrolled angina, arrhythmias, or congestive heart failure
- Concurrent systemic and local anti-cancer therapy
- Prior use of sorafenib, oxaliplatin or 5FU
- Major surgery within 30 days
- Concurrent use of aspirin>100mg
- Therapeutic anticoagulation with vitamin K antagonists or with heparins or heparinoids
Data sourced from ClinicalTrials.gov (NCT01775501). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.