A Study of Oxaliplatin and Capecitabine in Unresectable Metastatic Hepatocellular Cancer

NCT03026803 | Terminated Phase 2 Results DMC

• 1 other identifier: 05195
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 1

Brief Summary

This phase II trial is studying how well giving oxaliplatin and capecitabine together works in treating patients with liver cancer.

Conditions

Liver Cancer; Hepatocellular Cancer

Outcome Measures

Primary Outcomes (1)

• Response Rate

  Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR

  Up to 2 years

Study Arms (1)

Oxaliplatin and Capecitabine

EXPERIMENTAL

21 day cycle with Oxaliplatin 50mg/m2 day 1 and day 8 administered IV, Capecitabine 750 mg/m2 bid p.o. daily from day 1 to day 14

Drug: Oxaliplatin; Drug: Capecitabine

Interventions

Oxaliplatin DRUG

Given IV

Also known as: Eloxatin

Oxaliplatin and Capecitabine

Capecitabine DRUG

Given PO

Also known as: Xeloda

Oxaliplatin and Capecitabine

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients must have histologically confirmed hepatocellular carcinoma which is recurrent, metastatic or unresectable.
• Patients may have up to two prior chemotherapy regimes. In addition, they may have had previous radiation, chemoembolization, and/or alcohol injections.
• Patients must have measurable disease, defined as lesions that can be accurately measured in at least one dimension (longest diameter to be recorded) as ≥20 mm with conventional techniques or as ≥10 mm with spiral CT scan, and which has clearly progressed during the observation interval prior to participation in this study. Pleural effusions and ascites will not be considered measurable, but may be present in addition to the measurable lesion(s).
• Karnofsky performance status \> 70%.
• Patients should have an expected survival of at least 2 months.
• Leukocytes \>3,000/µl
• Absolute neutrophil count \>1,500/µl
• Platelets \>50,000/µl
• Total bilirubin \< 3.0 g/dl
• AST (aspartate aminotransferase) (serum glutamic oxaloacetic transaminase(SGOT)/ALT (alanine aminotransferase) (serum glutamic pyruvic transaminase)(SGPT) \< 5 times institutional upper limit of normal
• Creatinine \< 2.0 OR measured or calculated creatinine clearance \>60 mL/min for patients with creatinine levels above institutional normal
• Patients with no evidence of clinically significant neuropathy.
• All prior therapy must have been completed at least 4 weeks prior to the patient's entry on this trial.
• Women of childbearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately.
• Breastfeeding should be discontinued if the mother is treated with oxaliplatin.

You may not qualify if:

• Patients have prior oxaliplatin or xeloda treatment or undergoing therapy with other investigational agents.
• History of allergy to platinum compounds or to antiemetics appropriate for administration in conjunction with protocol-directed chemotherapy.
• Uncontrolled intercurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, or unstable angina pectoris, or cardiac arrhythmia.
• HIV-positive patients receiving anti-retroviral therapy (HAART) are excluded from the study because of possible pharmacokinetic interactions.
• Patients with a diagnosis of pulmonary fibrosis or a pulmonary interstitial process.
• Patients unable to swallow capecitabine will be excluded from this study.

Sponsors & Collaborators

• City of Hope Medical Center: lead
• Sanofi: collaborator

Study Sites (1)

City of Hope Medical Center

Duarte, California, 91010, United States

Location

MeSH Terms

Conditions

Liver Neoplasms

Interventions

Oxaliplatin; Capecitabine

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Liver Diseases

Intervention Hierarchy (Ancestors)

Coordination Complexes; Organic Chemicals; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Fluorouracil; Uracil; Pyrimidinones; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides

Limitations and Caveats

Due to Sorafenib becoming a first line treatment for HCC, the designed treatment became less competitive. The company Sanofi decided not to continue support. Study was terminated after accrual of 4 of the 32 planned patients.

Results Point of Contact

• Title: Jeffrey Longmate, Ph.D.
• Organization: City of Hope

jlongmate@coh.org

626-256-4673

Study Officials

• Yun Yen, MD

  City of Hope Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 17, 2017
• First Posted: January 20, 2017
• Study Start: November 1, 2006
• Primary Completion: October 1, 2014
• Study Completion: October 1, 2014
• Last Updated: April 13, 2017
• Results First Posted: March 10, 2017

Record last verified: 2017-03

Locations

US (1)