Study of RAD001 in Advanced Cholangiocarcinoma: RADiChol

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2009 by Austin Health.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Austin Health
ClinicalTrials.gov Identifier:
NCT00973713
First received: September 8, 2009
Last updated: NA
Last verified: September 2009
History: No changes posted
  Purpose

This is a clinical trial investigating the effectiveness and safety of the study drug RAD001 in patients with advanced (metastatic) cholangiocarcinoma. Palliative chemotherapy provides some benefit to this group of patients. However, chemotherapy treatment only shows low rates of radiological response and short times to tumour progression. Therefore, further treatment options are urgently required.

In laboratory studies, RAD001 has been shown to interrupt the signals that cancer cells use to grow, spread and form new blood vessels (angiogenesis). RAD001 has been approved for the treatment of kidney cancer. It has also been approved for use in Australia for the treatment of patients with kidney and liver transplants, and has been used in thousands of patients worldwide for this indication. Preliminary studies suggest that RAD001 may have activity in a range of other cancers. This study will evaluate the activity of RAD001 in advanced cholangiocarcinoma.


Condition Intervention Phase
Cholangiocarcinoma
Drug: RAD001
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase II Study of RAD001 in Advanced Cholangiocarcinoma

Resource links provided by NLM:


Further study details as provided by Austin Health:

Primary Outcome Measures:
  • Tumour control [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Overall survival [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • Toxicity [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 27
Study Start Date: September 2009
Estimated Study Completion Date: March 2012
Estimated Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: RAD001 10mg/d Drug: RAD001
10mg/d
Other Name: Everolimus

Detailed Description:

27 patients from approximately four hospitals in Australia will participate in this trial, with approximately 15 patients being enrolled at Austin Health. All participants will receive the same treatment (RAD001 10mg/d given orally).

After screening for eligibility, participants will receive RAD001 10mg/d until tumour progression.

Participants will undergo regular CT scans (every 6 weeks during treatment) to evaluate the effectiveness of treatment. Providing they are tolerating treatment satisfactorily, they may receive study treatment until progression of disease.

Blood samples will be taken during the screening phase and every 3 weeks during the treatment phase of the trial. Participants will be followed-up every 3 months to find out about survival status, new chemotherapy or biological treatment and the outcome of any ongoing adverse events.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Histologically/cytologically confirmed adenocarcinoma of gall bladder, intra or extra-hepatic biliary tract
  2. Metastatic or locally advanced (unresectable) disease
  3. Adequate organ function; creatinine<1.5xULN, BR<1.5xULN Neut>1.5, Pts>100
  4. WHO Performance status 0-2
  5. No prior chemotherapy for advanced Cholangiocarcinoma (Prior adjuvant chemotherapy is accepted)
  6. Measurable or non-measurable disease
  7. Informed consent for study participation and donation of tumour tissue for evaluation of relevant translational endpoints

Exclusion Criteria:

  1. Cytotoxic chemotherapy or immunotherapy within 4 weeks prior to enrolment
  2. Prior therapy with mTOR inhibitors (sirolimus, temsirolimus, everolimus)
  3. Known intolerance or hypersensitivity to RAD001 (everolimus) or other rapamycins (sirolimus, temsirolimus)
  4. Uncontrolled diabetes mellitus or hyperlipidaemia
  5. Patients who have any severe and/or uncontrolled medical conditions
  6. Active or uncontrolled severe infection
  7. Cirrhosis, chronic active hepatitis or chronic persistent hepatitis
  8. Severely impaired lung function
  9. Patients with a known history of HIV seropositivity
  10. Patients who have a history of another primary malignancy (Exceptions include non-melanoma skin cancer, carcinoma in situ of uterine cervix, or any other cancer treated with curative intent without evidence of relapse for more than 2 years)
  11. Female patients who are pregnant or nursing (lactating), or adults of reproductive potential who are not using effective birth control methods. If barrier contraceptives are being used, these must be continued throughout the trial by both sexes
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00973713

Contacts
Contact: Niall Tebbutt, FRACP +61394965763 niall.tebbutt@ludwig.edu.au
Contact: Effie Roiniotis, RN +61394963576 effie.roiniotis@ludwig.edu.au

Locations
Australia, Victoria
Austin Health Recruiting
Melbourne, Victoria, Australia, 3084
Contact: Effie Roiniotis, RN    +61394963576    effie.roiniotis@ludwig.edu.au   
Principal Investigator: Niall Tebbutt, FRACP         
Sponsors and Collaborators
Austin Health
  More Information

No publications provided

Responsible Party: Niall Tebbutt, Austin Health
ClinicalTrials.gov Identifier: NCT00973713     History of Changes
Other Study ID Numbers: H2009/3522
Study First Received: September 8, 2009
Last Updated: September 8, 2009
Health Authority: Australia: Human Research Ethics Committee

Keywords provided by Austin Health:
Advanced cholangiocarcinoma

Additional relevant MeSH terms:
Cholangiocarcinoma
Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Everolimus
Sirolimus
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Antibiotics, Antineoplastic
Antineoplastic Agents
Therapeutic Uses
Antifungal Agents
Anti-Infective Agents
Anti-Bacterial Agents

ClinicalTrials.gov processed this record on April 17, 2014