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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00464295
First Posted: April 23, 2007
Last Update Posted: December 14, 2007
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Aga Khan University
  Purpose
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.

Condition Intervention Phase
Carcinoma, Hepatocellular Drug: Capecitabine in HCC Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase II Trial of Capecitabine for the Treatment of Unresectable/ Metastatic or Advanced Hepatocellular Carcinoma(HCC)

Resource links provided by NLM:


Further study details as provided by Aga Khan University:

Primary Outcome Measures:
  • To evaluate response rate and overall survival after completing minimum of three cycles of Capecitabine in Advance HCC [ Time Frame: 12 months from the start of chemotherapy ]

Secondary Outcome Measures:
  • To evaluate the time to progression, toxicity and quality of life for patients on chemotherapy [ Time Frame: 12 months ]

Enrollment: 15
Study Start Date: August 2006
Study Completion Date: October 2007
  Show Detailed Description

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00464295


Locations
Pakistan
Aga Khan University
Karachi, Sind, Pakistan, 74800
Sponsors and Collaborators
Aga Khan University
Investigators
Principal Investigator: Muhammad K Anis, MD Aga Khan University
Principal Investigator: Zaigham Abbas, MD Aga Khan University
Study Director: Wasim Jafri, MD Aga Khan University
  More Information

Responsible Party: Muhammad Kashif Anis, Aga Khan University
ClinicalTrials.gov Identifier: NCT00464295     History of Changes
Other Study ID Numbers: 449-Med/ERC-05
First Submitted: April 20, 2007
First Posted: April 23, 2007
Last Update Posted: December 14, 2007
Last Verified: December 2007

Keywords provided by Aga Khan University:
Hepatocellular Carcinoma
Phase 2 Trial
Capecitabine
Treatment Efficacy

Additional relevant MeSH terms:
Carcinoma
Carcinoma, Hepatocellular
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Adenocarcinoma
Liver Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Liver Diseases
Capecitabine
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents