Combined Modality Treatment of Sarcomas of the Extremities

NCT01985295 | Completed Phase 1

• 2 other identifiers: M09RTP2009-014901-15
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

In this study, we aim to define the recommended dose of a VEGFR-TKI (pazopanib) in combination with RT pre-operatively given.

Conditions

Sarcoma,Soft Tissue

Outcome Measures

Primary Outcomes (1)

• Dose limiting toxicity

  To study the safety and feasibility of adding 6 weeks of orally administered Pazopanib to 25 x 2Gy in 5 weeks preoperative radiotherapy in extremity or head and neck area soft tissue sarcoma patients (to identify the Dose Limiting Toxicity (DLT) and the Recommend Phase II Dose (RPTD) if pazopanib is added to 50 Gy pre-operatively)

  14 weeks

Secondary Outcomes (1)

• the exploration/feasibility of dynamic imaging

  14 weeks

Study Arms (1)

cohort

OTHER

Dose level Dose of pazopanib orally, once daily, # patients -1 200 mg -- 1. (starting) 400 mg 3 2. 600 mg 3 3. (maximum) 800 mg 3

Drug: pazopanib

Interventions

pazopanib DRUG

A dose escalation trial of Pazopanib, starting at 400mg daily, orally in combination with the standard 25 x 2Gy preoperative radiotherapy in newly diagnosed extremity sarcoma patients. Dose of pazopanib will be escalated via 600mg to maximally 800mg. Overall treatment time of pazopanib is 40 days.

Also known as: Compound Number: GW786034

cohort

Eligibility Criteria

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

You may qualify if:

• Histologically confirmed newly diagnosed intermediate to high grade soft tissue sarcoma of and localized to the extremities or head and neck area for which the treatment is a combination of both surgery and radiotherapy (deep seated, \> 5cm according to the RECIST 1.1 criteria, grade II/III according to the WHO definition).
• Age \> 18 years.
• Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.
• Absence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before registration in the trial.
• Before patient registration/randomization, written informed consent must be given according to ICH/GCP, and national/local regulations.
• Able to swallow and retain oral medication. 7. A life expectancy of at least 12 weeks. 8. Adequate organ function.

You may not qualify if:

• Prior malignancies; except subjects who have had another malignancy and have been disease-free for 5 years, or subjects with a history of completely resected non-melanomatous skin carcinoma or successfully treated in situ carcinoma are eligible.
• Patients with recurrent sarcomas (even without prior radiotherapy).
• Ewing sarcoma and other PNET family tumours, rhabdomyosarcomas (both pediatric and adult), osteosarcomas.
• Clinically significant gastrointestinal abnormalities which might interfere with oral dosing diagnosed as:
• Active peptic ulcer disease.
• Known intraluminal metastatic lesions with suspected bleeding.
• Inflammatory bowel disease, ulcerative colitis, or other gastrointestinal conditions with increased risk of perforation.
• History of abdominal fistula, gastrointestinal perforation, or intra abdominal abscess within 28 days prior to beginning study treatment.
• Major resection of the stomach or small bowel.
• Uncontrolled hypertension.
• Unstable or serious concurrent condition (e.g., active infection requiring systemic therapy).
• Prolongation of corrected QT interval (QTc) \>480 msecs.
• History of any one of more of the following cardiovascular conditions within the past 6 months:
• Cardiac angioplasty or stenting.
• Myocardial infarction.

Sponsors & Collaborators

• The Netherlands Cancer Institute: lead
• GlaxoSmithKline: collaborator

Study Sites (1)

The Netherlands Cancer Institute

Amsterdam, North Holland, 1066CX, Netherlands

Location

MeSH Terms

Conditions

Sarcoma

Interventions

pazopanib

Condition Hierarchy (Ancestors)

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

Study Officials

• Rick Haas, MD,PhD

  NKI

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 7, 2013
• First Posted: November 15, 2013
• Study Start: June 1, 2010
• Primary Completion: August 1, 2014
• Study Completion: November 1, 2014
• Last Updated: October 9, 2015

Record last verified: 2015-10

Locations

NL (1)