Sunitinib and Radiation in Patients With Resectable Soft-tissue Sarcoma

NCT00753727 | Unknown Phase 1 DMC

• 1 other identifier: ASSG01
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

Brief Summary

This research is being done with the aim of developing a more effective treatment than standard radiotherapy and surgery alone. Although standard treatment is frequently successful, some patients do not respond well to this treatment. Low oxygen levels in tumours, which may be a particular problem with sarcomas, are thought to be one factor that contributes to failure of radiotherapy. Sunitinib is a new drug that is active against cells with low oxygen levels. The combination of sunitinib and radiotherapy has shown promising results in other cancers. The purpose of this study is to find out whether treatment with a new drug, sunitinib, can increase the effectiveness of radiotherapy at killing cancer cells; to test the safety of the combination of sunitinib and radiotherapy.

Conditions

Soft Tissue Sarcoma

Keywords

soft tissue; Sarcoma; Sunitinib; neoadjuvant; radiotherapy

Outcome Measures

Primary Outcomes (1)

• To determine the maximum dose of sunitinib at which the combination of sunitinib and radiotherapy pre-operatively is safe and tolerable.

  Baseline; post-2 weeks sunitinib only administration; post-sunitinib and radiotherapy combination treatment; 12 weeks post-surgery

Secondary Outcomes (1)

• To estimate response rates for the combination of sunitinib and radiotherapy.

  Baseline; post-2 weeks sunitinib only administration; post-sunitinib and radiotherapy combination treatment; and at surgery

Interventions

Sunitinib malate DRUG

Sunitinib dose 50 mg/day orally for 2 weeks prior to radiotherapy. Treatment Dose Levels during radiotherapy: Dose level 0: Sunitinib 50mg/day for 2 weeks prior to radiotherapy, followed by 25mg/day given concurrently with radiotherapy; Dose level 1: Sunitinib 50mg/day for 2 weeks prior to radiotherapy, followed by 37.5mg/day given concurrently with radiotherapy; Dose level -1: Sunitinib 37.5mg/day for 2 weeks prior to radiotherapy, followed by 37.5mg/day given concurrently with radiotherapy. Dose escalation/de-escalation: first 6 patients will be accrued at dose level 0. The dose levels at which subsequent patients will be accrued will be determined using a dose modification schedule.

Also known as: Sutent

Radiotherapy RADIATION

Preoperative radiotherapy consisting of external beam radiotherapy at a dose of 50.4 Gy given in 28 fractions, five days a week, over five weeks and 3 days to the planning target volume.

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Histologically confirmed soft-tissue sarcoma suitable for neoadjuvant radiotherapy and surgery
• minimum age 16 years
• ECOG performance status =1
• life expectancy of greater than 6 months
• patients must have normal organ and marrow function
• no evidence of a bleeding or thrombotic tendency, and no evidence of arterial or venous thrombosis
• not pregnant or breastfeeding
• the ability to give written informed consent.

You may not qualify if:

• Soft-tissue sarcoma located in sites where radiotherapy is associated with significant exposure of abdominal viscera
• patients with other invasive malignancies, with the exception of non-melanoma skin cancer, in the last 5 years
• patients receiving any other therapeutic investigational agents
• patients who are receiving concurrent treatment with any other anti-cancer therapy
• evidence of distant metastases
• uncontrolled intercurrent illness
• patients who are pregnant or breast feeding.

Sponsors & Collaborators

• Australasian Sarcoma Study Group: lead
• Peter MacCallum Cancer Centre, Australia: collaborator
• Pfizer: collaborator

Study Sites (1)

Peter MacCallum Cancer Centre

Melbourne, Victoria, 3002, Australia

RECRUITING

MeSH Terms

Conditions

Sarcoma

Interventions

Sunitinib; Radiotherapy

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Pyrroles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Therapeutics

Study Officials

• David Thomas, MB BS PhD

  Peter MacCallum Cancer Centre, Australia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: September 14, 2008
• First Posted: September 16, 2008
• Study Start: September 1, 2008
• Primary Completion: March 1, 2012
• Study Completion: March 1, 2016
• Last Updated: June 23, 2011

Record last verified: 2010-12

Locations

AU (1)