Phase II Trial of Capecitabine for the Treatment of Unresectable/ Metastatic or Advanced Hepatocellular Carcinoma(HCC)

NCT00464295 | Completed Phase 2

• 1 other identifier: 449-Med/ERC-05
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

In patients with unresectable/advanced Hepatocellular Carcinoma receiving Capecitabin, we anticipate that the proposed chemotherapy will have a delay in progression of the disease . It is also expected that proposed chemotherapy will have acceptable toxicity and Quality of life.

Conditions

Carcinoma, Hepatocellular

Keywords

Hepatocellular Carcinoma; Phase 2 Trial; Capecitabine; Treatment Efficacy

Outcome Measures

Primary Outcomes (1)

• To evaluate response rate and overall survival after completing minimum of three cycles of Capecitabine in Advance HCC

  12 months from the start of chemotherapy

Secondary Outcomes (1)

• To evaluate the time to progression, toxicity and quality of life for patients on chemotherapy

  12 months

Interventions

Capecitabine in HCC DRUG

Eligibility Criteria

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

You may qualify if:

• Written informed consent.
• Age between 18 and 70 years.
• Documented by at least 2 out of three mentioned criteria and evidence of non-resectability.
• Radiological either CT Scan/US abdomen
• Biopsy,
• Serum alphafeto protein level
• Multi centric hepatoma or TNM Classification Stage IV.
• Child's class B or C with a Child's score of maximum 11.
• No other active malignancy except localized basal or squamous cell carcinoma of the skin or carcinoma in situ of the cervix.
• Life expectancy of greater then 3 months.
• Current laboratory values must be within the limits listed below:
• Haemoglobin \> 8 g/dL WBC \> 4,000/uL Absolute Neutrophil Count \> 1,500/uL Platelets \> 75,000/uL
• ECOG Performance status of \< 2.
• Patients who have received adjuvant or neoadjuvant therapy are eligible. A minimum interval of 4 weeks since last chemotherapy will be required.
• Prior radiotherapy will be allowed if it did not involve a site used to assess response and 4 weeks have elapsed since completion of radiotherapy.

You may not qualify if:

• History of allergic reaction to compound chemically related to CAP.
• Concomitant or previous malignancies within five years other than basal or squamous cell carcinoma of the skin and carcinoma in situ of the cervix.
• Active, uncontrolled infection. .
• Concurrent medical problems which could limit the life expectancy or the ability of the patient to receive chemotherapy.
• Mental condition that could limit the patient in comprehending the concept of clinical trial or complying with its requirements.
• Brain or leptomeningeal involvement.
• Pre-existing neurotoxicity of \>=grade 2.
• Concomitant radiotherapy, unless localised for bone pain control or palliation.
• Being of reproductive potential and not agreeing to practice an effective contraceptive method.
• Pregnancy or lactation.
• Severe renal impairment with Creatinine clearance \<30ml/minute.
• Documented Cardiomyopathy or severe coronary artery disease, or history of arrhythmias.

Sponsors & Collaborators

• Aga Khan University: lead

Study Sites (1)

Aga Khan University

Karachi, Sindh, 74800, Pakistan

Location

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Interventions

Capecitabine

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases

Intervention Hierarchy (Ancestors)

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

Study Officials

• Muhammad K Anis, MD

  Aga Khan University

  PRINCIPAL INVESTIGATOR

• Zaigham Abbas, MD

  Aga Khan University

  PRINCIPAL INVESTIGATOR

• Wasim Jafri, MD

  Aga Khan University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: April 20, 2007
• First Posted: April 23, 2007
• Study Start: August 1, 2006
• Study Completion: October 1, 2007
• Last Updated: December 14, 2007

Record last verified: 2007-12

Locations

PA (1)