Capital & Coast District Health Board (CCDHB)

• Specialist tertiary organisation

Wellington Blood and Cancer Centre

• Integral part of Capital & Coast District Health Board.
• Cancer Services for approximately 900,000 people covering -
  Wellington City and Suburbs
  Blenheim / Marlborough
  Wairarapa
  Hutt Valley
  Kapiti Coast
  Porirua Basin
  Wider region for specialised services

The Cancer Research Unit

• A vital part of the Wellington Blood and Cancer Centre
• Provision of high quality clinical trials
• Aiming to improve patient outcomes
• Maximisation of patient and staff participation
• Educational goals and strategies
• Develop alliances with other research groups nationally & internationally
• Creating supportive environment for patients and staff
• Provision of adequate resources

A Phase 3 Randomised, Study of a New Oral Anti-cancer therapy Administered in Combination with Letrozole vs. Letrozole Alone as First Line Hormonal Therapy in Postmenopausal Women with Locally Advanced or Metastatic Breast Cancer.

Purpose

The purpose of this phase III trial is to determine if combining a new anti-cancer agent with Letrozole will help post menopausal women with metastatic breast cancer to have a longer period before their breast cancer progresses (grows) than if they had Letrozole on its own.

Inclusion Criteria:

• Women aged 18 years or above who are post menopausal.
• Confirmed diagnosis of locally advanced or metastatic breast cancer.
• Oestrogen receptor positive and/or progesterone receptor positive
• At least one tumour lesion that can be measured
• Adequate kidney and liver function.
• Adequate bone marrow function.
• Acceptable fasting cholesterol and lipids.
• Adequate performance status.
• Life expectancy of at least 6 months.
• Ability to swallow whole tablets.

Exclusion Criteria:

• o Extensive disease to lung), brain or nervous system, or liver
• Patients who have disease to the bones only.
• History of inflammatory breast cancer.
• o Any other cancer within 5 years prior to screening (There are exceptions you would need to ask your Oncologist).
• Unstable heart conditions.
• More than one regime of anti-cancer therapy for metastatic breast cancer.

For further information contact Jayne Bowers at Phone 918 5134.

A Randomised Phase II Study Comparing Capecitabine with Capecitabine & oral Cyclophosphamide in Patients with Advanced Breast Cancer- CycloX II

Purpose

The purpose of this phase II trial is to see if using two oral chemotherapy drugs (capecitabine and cyclophosphamide) together is a safe and acceptable treatment for women with advanced breast cancer. This trial will look to see if there is a difference in the side effects between using capecitabine on it's own or with cyclophosphamide. It will also help decide if there may be a difference in the effectiveness of the two treatments in breast cancer, and if there is a difference in the quality of life that will be measured in patients on the two treatments.

Inclusion Criteria:

• Histological or cytological evidence of breast cancer.
• Measurable disease as determined by RECIST.
• Treatment with palliative intent.
• Performance status (WHO) 0-3.
• Adequate renal and liver function.
• Adequate bone marrow function.
• Accessible for treatment and follow up.
• Written informed consent.

Exclusion Criteria:

• Male.
• Less than 6 months following last dose of adjuvant therapy.
• More than one prior regime for advanced disease.
• Unsuitable for either treatment with cyclophosphamide or capecitabine.
• Indication for chemotherapy more intensive than capecitabine and cyclophosphamide.
• Brain and/or leptomeningeal disease.
• Age less than 18 years.
• Pregnant or breastfeeding women.
• Women of childbearing potential, who are unwilling to practice adequate contraception.
• nvestigational drug therapy within 30 days prior to randomisation.
• Concurrent anticancer therapy
• Other malignancy within 5 years except adequately basal cell or squamous cell cancer of skin or in situ cancer of the cervix.
• Known infection with the Human Immunodeficiency Virus (HIV).
• Treatment with antiviral agent sorivudine, or related compounds such as brivudine.

To evaluate safety, efficacy, PRO, and population PK of sorafenib versus placebo in patients with advanced Hepatocellular carcinoma.

Purpose

The purpose of this phase III, randomized, placebo-controlled study is to evaluate the safety and efficacy of sorafenib versus placebo in patients with advanced hepatocellular carcinoma (HCC).

BAY 43-9006 is an investigational drug being studied as a potential treatment for hepatocellular carcinoma. 100554 (A Phase III randomized, placebo-controlled study of sorafenib in patients with advanced hepatocellular carcinoma is being conducted in 23 countries to evaluate the safety and efficacy (effectiveness) of BAY 43-9006.

Inclusion Criteria:

• Male or female patients > 18 years of age.
• Patients who have a life expectancy of at least 12 weeks.
• Patients with advanced HCC.
• Patients with histologically or cytologically documented HCC.
• Patients must have at least one tumour lesion that meets both of the following criteria:
• accurately measured in at least one dimension according to RECIST.
• not previously treated with local therapy.
• Patients who have received local therapy. Previously treated lesions will not be selected as target lesions. Local therapy must be completed at least 4 weeks prior to the baseline scan.
• Patients who have an ECOG PS of 0, 1, or 2.
• Cirrhotic status of Child-Pugh classes A only.

Exclusion Criteria:

• Previous or concurrent cancer that is distinct in primary site or histology from HCC, EXCEPT cervical carcinoma in situ, treated basal cell carcinoma, superficial bladder tumors (Ta, Tis & T1). Any cancer curatively treated > 3 years prior to entry is permitted.
• Renal failure requiring hemo - or peritoneal dialysis.
• History of cardiac disease.
• Active clinically serious infections.
• Known history of human immunodeficiency virus (HIV) infection.
• Known Central Nervous System tumors including metastatic brain disease.
• Patients with clinically significant gastrointestinal bleeding within 30 days prior to study entry.

ONCONASE ® plus doxorubicin vs. doxorubicin for patients with Malignant Pleural or Peritoneal Mesothelioma who have had no more than one prior chemotherapy regimen.

Purpose

The purposes of this study are to determine:

• The safety of ONCONASE ® plus doxorubicin and any side effects that might be associated with the combination of these two drugs.
• Whether ONCONASE ® plus doxorubicin can help patients with mesothelioma live longer.
• Whether ONCONASE ® plus doxorubicin can make the tumour smaller or disappear, and for how long.
• Whether patients feel better while taking ONCONASE ® plus doxorubicin. Patients who have taken Alimta may be eligible. Treatment duration will be at least 18 weeks.

Inclusion Criteria:

• Adult patients with unresectable malignant mesothelioma.
• Patients must have no more than one previous chemotherapy regimen (excluding doxorubicin). Prior surgery or radiation is allowed.
• Patients must have an acceptable performance status.
• Patients must have signed an informed consent.

• Patients who have received more than 1 prior systemic chemotherapy, or any prior treatment with doxorubicin.
• Patients with symptomatic cardiovascular disease, congestive heart failure, angina pectoris, cardiac arrhythmia(s), or uncontrolled hypertension.
• Patients with serious infections will be excluded until such infections are under control.
• Patients with uncontrolled psychiatric disorders or neurologic diseases. Please note that more specific inclusion / exclusion criteria must be met prior to entering this trial.

Purpose

The primary objective of this phase III trial is to compare the survival of patients with metastatic malignant melanoma treated with Taxoprexin® Injection to those treated with Dacarbazine. In addition, the response rate to each drug, response duration, time to progression and time to treatment failure will be measured. Toxicity will be evaluated and compared between the two groups.

Expected Total Enrolment: 575 Study start: October 2002

Inclusion Criteria:

• Patients must have malignant melanoma, and documented metastatic disease.
• Patients must have at least one unidimensionally measurable lesion.
• Patients must have at least one unidimensionally measurable lesion.
• Patients must not have received prior systemic chemotherapy for metastatic disease. Prior treatment with immunotherapy or vaccine therapy is allowed provided there is documentation of disease progression.
• At least 6 weeks (42 days) since any prior immunotherapy, cytokine, biologic, vaccine or other therapy unless patients have progressed during immunotherapy.
• At least 4 weeks (28 days) since any prior radiotherapy.
• Lesions being used to assess disease status may not have been radiated.
• Patients must have ECOG performance status of 0 - 2.
• Patients must be18 years of age and above.
• Patients must have adequate renal and liver function
• Patients must have adequate bone marrow function.
• Life expectancy of at least 3 months.
• Patients must sign an informed consent form indicating that they are aware of the investigational nature of this study and in keeping with the policies of the institution.

Exclusion Criteria:

• Patients who have received prior therapy with any taxane or dacarbazine.
• Patients whose primary site is the eye.
• Patients who have a past or current history of neoplasm other than the entry diagnosis, except for curatively treated non-melanoma skin cancer or carcinoma in situ of the cervix or other cancers cured by surgery alone with a disease-free survival longer than 5 years.
• Patients with uncontrolled brain metastasis.
• Patients who are pregnant or nursing and patients who are not practicing an acceptable method of birth control. Patients may not breastfeed while on this study.
• Patients with current active infections requiring ant-infectious treatment (e.g antibiotics, antivirals, or antifungals).
• Patients with current peripheral neuropathy of any etiology that is greater than grade 1.
• Patients with unstable or serious concurrent medical conditions are excluded.
• Patients with a known hypersensitivity to Cremophor.
• Patients must not have had recent major surgery within the past 14 days or large field radiation therapy, chemotherapy, endocrine therapy in the last 28 days, or biologic therapy in the last 42 days.

Adjuvant GIST: a controlled randomised trial of adjuvant Imatinib mesylate (Glivec^TM) versus no further therapy after complete surgery.

Purpose

The purpose of the adjuvant GIST study is to determine if Imatinib when administered at a dose of 400mg per day for 2 years will improve overall survival (i.e. reduce the number of deaths due to any cause), prolong the time to relapse and have an acceptable safety profile in patients with fully resected intermediate and high risk localised GIST.

Inclusion Criteria:

• Confirmed histological diagnosis of GIST.
• Surgery performed from 2 weeks to 3 months before randomisation.
• No evidence of residual macroscopic disease after surgery.
• No previous anti-cancer treatments.
• Absence of distant metastases.
• Patients must be aged 18 years or above.
• Adequate performance status.
• Adequate renal and liver function.
• Adequate bone marrow function.

Exclusion Criteria:

• No prior, or ongoing other malignancy within 5 years prior to screening (There are exceptions you would need to ask your Oncologist).
• No ongoing pregnancy or nursing.
• No active heart disease.
• Absence of severe and/or uncontrolled medical disease.

Contact Details

Clinical Research Unit
Wellington Blood and Cancer Centre,
Private Bag 7902,
Wellington
Via email: monitoring.A1@ccdhb.org.nz