Status:
COMPLETED
Phase II Trial of Capecitabine for the Treatment of Unresectable/ Metastatic or Advanced Hepatocellular Carcinoma(HCC)
Lead Sponsor:
Aga Khan University
Conditions:
Carcinoma, Hepatocellular
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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 expecte...
Detailed Description
II. OBJECTIVES II.A. Primary Objectives: To evaluate response rate (RR) and overall survival (OS). II.B. Secondary Objective: To evaluate the time to progression (TTP), median time to response (MTR)...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
August 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2007
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT00464295
Start Date
August 1 2006
End Date
October 1 2007
Last Update
December 14 2007
Active Locations (1)
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1
Aga Khan University
Karachi, Sindh, Pakistan, 74800