Ph II Cabazitaxel DD Liposarcoma

NCT01913652 | Completed Phase 2 DMC

• 3 other identifiers: EORTC-12022012-003672-39cabazL06470
• Study Type: interventional
• Target: 42
• Locations: 4 countries
• Sites: 11

Brief Summary

Soft tissue sarcomas (STS) are a rare group of malignant heterogenous tumors (\> 50 histological subtypes, including liposarcoma, the commonest subtype of STS) with distinct genetic, pathological and clinical profiles, and varying patterns of tumor spread. The optimal cytotoxic treatment for this group of patients remains uncertain. Single agents which are most effective include doxorubicin and ifosfamide, but objective response rates and progression-free survival times remain modest. There is clearly a need to improve treatment options for liposarcoma. Eribulin, a antimicrotubule agent that targets the protein tubulin in cells, interfering with cancer cell division and growth , has demonstrated activity in STS. Therefore, it is reasonable to explore whether other anti-microtubule agent like cabazitaxel have a role in STS. Cabazitaxel has been shown to be a relatively safe, effective and tolerated. This drug has been approved by FDA for prostate cancer. The main objective of this trial is to determine whether cabazitaxel demonstrate sufficient antitumor activity for liposarcoma.

Conditions

Dedifferentiated Liposarcoma

Keywords

dedifferentiated liposarcoma; cabazitaxel

Outcome Measures

Primary Outcomes (1)

• Progression free survival (PFS)

  The primary endpoint will be progression free survival, assessed at 12 weeks after start of treatment

  3 years from first patient in

Secondary Outcomes (7)

• Time to progression

  3 years from first patient in

• Progression free survival

  3 years from first patient in

• Overall survival

  3 years from first patient in

• Objective tumor response

  3 years from first patient in

• Time to onset of response

  3 years from first patient in

Study Arms (1)

Cabazitaxel

EXPERIMENTAL

INN: Cabazitaxel Cabazitaxel will be administered at a dose of 25 mg/m² by intravenous infusion, over 1 hour, on day 1 of each 21 day cycle. Treatment should be administered until disease progression, unacceptable toxicity or patient's refusal.

Drug: Cabazitaxel

Interventions

Cabazitaxel DRUG

Also known as: Jevtana

Cabazitaxel

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Local diagnosis of dedifferentiated liposarcoma
• Age 18-75 yrs
• WHO performance status 0-1
• Radiological or histological diagnosis of inoperable locally advanced or metastatic disease, with evidence of disease progression within the past 6 months
• Clinically and/or radiographically documented measurable disease within 21 days prior to randomization.At least one site of disease must be unidimensionally measurable according to RECIST 1.1.
• One previous chemotherapy regimen for locally advanced or metastatic dedifferentiated liposarcoma (this could include pre-operative chemotherapy for primary disease if subsequent complete resection was not achieved).
• Adequate haematological, renal and hepatic function
• Birth control measures
• Estimated life expectancy \> 3 months
• Related adverse events from previous therapies ≤ Grade 1
• Written informed consent

You may not qualify if:

• More than 1 prior molecularly targeted therapy (e.g. CDK4 inhibitor). Any prior such therapy must be completed at least 4 weeks before randomization.
• Symptomatic CNS metastases
• Previous encephalopathy of any cause or other significant neurological condition
• Concurrent or planned treatment with strong inhibitors or inducers of cytochrome P450 3A4/5
• Pregnancy
• inflammation of the urinary bladder (cystitis)
• Other invasive malignancy within 5 years (exceptions of non-melanoma skin cancer, localized cervical cancer, localized and presumably cured prostate cancer or adequately treated basal or squamous cell skin carcinoma)
• Significant cardiac disease
• Uncontrolled severe illness or medical condition, other than DD liposarcoma
• Hypersensitivity to taxanes or their excipients

Sponsors & Collaborators

• European Organisation for Research and Treatment of Cancer - EORTC: lead
• Sanofi: collaborator

Study Sites (11)

Universitair Ziekenhuis Antwerpen (117)

Antwerp, Belgium

Location

Hopitaux Universitaires Bordet-Erasme - Institut Jules Bordet (101)

Brussels, Belgium

Location

CHU de Dijon - Centre Georges-Francois-Leclerc (229)

Dijon, 21079, France

Location

Centre Leon Berard (227)

Lyon, France

Location

Assistance Publique - Hopitaux de Marseille - Hôpital de La Timone (287)

Marseille, France

Location

Fondazione IRCCS Istituto Nazionale dei Tumori (704)

Milan, Italy

Location

Istituto Oncologico Veneto IRCCS - Ospedale Busonera (3908)

Padua, Italy

Location

Clatterbridge Centre for Oncology NHS Trust - Clatterbridge Cancer Centre NHS Foundation Trust (659)

Bebington, United Kingdom

Location

Western General Hospital

Edinburgh, EH4 2XU, United Kingdom

Location

Royal Marsden Hospital - Chelsea, London (613)

London, United Kingdom

Location

The Christie NHS Foundation Trust (610)

Manchester, United Kingdom

Location

MeSH Terms

Conditions

Liposarcoma

Interventions

cabazitaxel

Condition Hierarchy (Ancestors)

Neoplasms, Adipose Tissue; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Sarcoma

Study Officials

• Larry Hayward, MD

  Western General Hospital, Edinburgh, United Kingdom

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 30, 2013
• First Posted: August 1, 2013
• Study Start: October 1, 2014
• Primary Completion: December 1, 2020
• Study Completion: December 1, 2020
• Last Updated: September 14, 2021

Record last verified: 2021-09

Locations

IT (2); BE (2); GB (4); FR (3)