A Phase I/II Study of First Line Vorinostat With Pemetrexed-cisplatin, in Patients With Malignant Pleural Mesothelioma

• Status: Withdrawn
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

Mesothelioma is a relatively rare cancer which is becoming more common. It can affect one of two areas; the pleura (the lining of the lung) or the peritoneum (the lining of the abdomen). Cancer affecting the pleura is the more common of these and is called Pleural Mesothelioma. This is most commonly caused by exposure to asbestos.

Unfortunately mesothelioma is usually diagnosed at an advanced stage and so treatment is based around controlling the disease and managing the symptoms, rather than curing the disease.

The standard treatment for Advanced Malignant Pleural Mesothelioma is a combination of two anticancer drugs; Pemetrexed and Cisplatin.

The trial will look into whether there are benefits of adding a third drug called Vorinostat to the treatment.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University College, London
• Collaborator: Merck Sharp & Dohme Corp.
• Treatments: Cisplatin; Pemetrexed; Vorinostat

Criteria

Inclusion Criteria:

• Pathological confirmation of malignant pleural mesothelioma

• Measurable disease using modified RECIST criteria with at least one lesion ≥ 1cm using spiral CT in a single dimension. This scan must be within 28 days of randomisation.

• Performance status ECOG 01

• Age > 18

• Able to swallow oral medication

• Adequate haematological status

• Adequate organ function

• Negative serum or urine pregnancy test. Male subject agrees to use an acceptable method of birth control for the duration of the study and contraception must be used by women of child bearing potential.

• Ability to understand and willing to sign the written informed consent to participate (including donation of diagnostic biopsy tissue for research).

• Ability to comply with the requirements of the protocol

Exclusion Criteria:

• Other investigational or commercial agents or therapies administered with the intent of treating the patient's malignancy.

• Evidence of CNS metastases that in the opinion of the investigator should receive local treatment prior to systemic cytotoxic chemotherapy

• Uncontrolled intercurrent illness

• The patient has a history of prior malignant tumour, unless the patient has been without evidence of disease for at least three years, or the tumour was a nonmelanoma skin tumour or insitu cervix carcinoma.

• Prior exposure to vorinostat or another HDAC inhibitor is not allowed. Prior valproic acid is acceptable but only if there has been at least 30 days washout period

• Preplanned surgery or procedures that would interfere with the conduct of the study.

• Patients who have had surgery within 28 days of randomisation

• Receipt of extensive radiation therapy, systemic chemotherapy, or other antineoplastic therapy within 4 weeks before enrolment is not allowed. However, drain site radiotherapy is allowed.