Status:
COMPLETED
Docetaxel With or Without AZD6244 in Melanoma
Lead Sponsor:
University of Oxford
Conditions:
Melanoma
Eligibility:
All Genders
16+ years
Phase:
PHASE2
Brief Summary
This is a randomised, double-blind placebo controlled phase 2 trial. Patient will be randomly assigned 1:1 between 2 treatment arms. They will receive either docetaxel 75mg/m2 IV and placebo given bd,...
Detailed Description
No further information in addition to what has been provided in the brief summary
Eligibility Criteria
Inclusion
- Aged \>/= 16 years
- Able to provide evidence from an accredited laboratory of wt BRAF status for their melanoma, or ascertainment of wt BRAF status from a sample of melanoma provided for mutational analysis in Oxford.
- Unresectable stage 3 or 4, histologically proven cutaneous or unknown primary melanoma
- At least 1 lesion, not previously irradiated, that can be accurately measured on CT or MRI as defined by modified RECIST criteria
- ECOG performance score of 0 or 1.
- Life expectancy of at least 12 weeks.
- The patient is willing to give consent to the main study and able to comply with the protocol for the duration of the study, including scheduled follow-up visits and examinations.
- Haematological and biochemical indices within the ranges shown below. Lab Test Value required Haemoglobin (Hb) \>10g/dL White Blood Count (WBC) \> 3x109/L Platelet count \> 100,000/μL Absolute Neutrophil count \> 1.5x109/L; Serum bilirubin ≤ 1.2 x ULN AST (SGOT) or ALT ≤ 2.5 x ULN LDH ≤ 2 x ULN Creatinine clearance (Cockcroft-Gault) \>50 ml/min
Exclusion
- Any anti-cancer therapy (including radiotherapy and participation in other clinical trials) within 28 days prior to Day 1.
- Prior DNA damaging agents or cytotoxic chemotherapy for metastatic melanoma.
- Any unresolved toxicity from prior anti-cancer therapy that is greater than CTCAE grade 2.
- Pregnancy or breastfeeding women. Female patients must have a negative urinary or serum pregnancy test or have evidence of post-menopausal status (defined as absence of menstruation for \> 12 months, bilateral oophrectomy or hysterectomy).
- Grade ≥2 peripheral neuropathy at study entry.
- Patients of reproductive potential who are not willing to use adequate contraceptive measures for the duration of the study (both male and female patients)
- Known severe hypersensitivity reactions to docetaxel or other drugs formulated in polysorbate 80
- Ocular or mucosal malignant melanoma
- Another active malignancy within the past five years.
- Evidence of brain metastases, unless surgically resected/stereotactic radiosurgery treated brain metastasis with no evidence of relapse on cerebral MRI, or treated brain metastasis and stable off treatment, including steroids, for 3 months.
- Clinically significant and uncontrolled major medical condition(s): such as active infection, bleeding diathesis.
- Patients who are known to be serologically positive for Hepatitis B, Hepatitis C or HIV.
- Cardiac conditions, including uncontrolled hypertension (BP\>160/100 despite treatment), heart failure NYHA class 2 or above, prior or current cardiomyopathy, myocardial infarction within 6 months or angina requiring nitrate therapy more than once a week.
- Previous treatment with EGFR, ras, raf or MEK inhibitors.
- Inability to swallow capsules, refractory nausea and vomiting, chronic gastrointestinal diseases (eg, inflammatory bowel disease) or significant bowel resection that would preclude adequate absorption.
- Taking medication that significantly induces or inhibits CYP3A4.
Key Trial Info
Start Date :
October 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2020
Estimated Enrollment :
83 Patients enrolled
Trial Details
Trial ID
NCT01256359
Start Date
October 1 2010
End Date
February 1 2020
Last Update
August 15 2024
Active Locations (1)
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1
Churchill Hospital
Oxford, Oxfordshire, United Kingdom, OX3 7LJ