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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:
Information provided by:
Aga Khan University
ClinicalTrials.gov Identifier:
NCT00464295
First received: April 20, 2007
Last updated: December 13, 2007
Last verified: December 2007
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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 ] [ Designated as safety issue: No ]

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

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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Muhammad Kashif Anis, Aga Khan University
ClinicalTrials.gov Identifier: NCT00464295     History of Changes
Other Study ID Numbers: 449-Med/ERC-05
Study First Received: April 20, 2007
Last Updated: December 13, 2007
Health Authority: Pakistan: ERC Aga Khan University Karachi

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

Additional relevant MeSH terms:
Carcinoma
Carcinoma, Hepatocellular
Adenocarcinoma
Digestive System Diseases
Digestive System Neoplasms
Liver Diseases
Liver Neoplasms
Neoplasms
Neoplasms by Histologic Type
Neoplasms by Site
Neoplasms, Glandular and Epithelial
Capecitabine
Fluorouracil
Antimetabolites
Antimetabolites, Antineoplastic
Antineoplastic Agents
Immunologic Factors
Immunosuppressive Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on November 27, 2014