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

• Status: Completed
• Trial end date: 2007-10-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Aga Khan University
• Treatments: Capecitabine

Criteria

Inclusion Criteria:

• Written informed consent.

• Age between 18 and 70 years.

• Documented by at least 2 out of three mentioned criteria and evidence of non-resectability.

1. Radiological either CT Scan/US abdomen

2. Biopsy,

3. 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.

Exclusion Criteria:

• 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.