MedTrace Logo

Docetaxel With or Without Low-dose, Short Course Sunitinib in Refractory Solid Tumors

NCT01803503 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2016-06-22

No results posted yet for this study

Summary

This study aims to find out whether the effect of docetaxel chemotherapy may be improved by combining it with another anti-cancer drug called sunitinib, which stops blood vessels from growing (anti-angiogenic agent). Sunitinib is an oral anti-angiogenic drug that has been approved for the treatment of kidney cancer, a rare form of soft tissue tumor called gastrointestinal stromal tumor, and a rare form of cancer in the pancreas called pancreatic neuroendocrine tumor. Sunitinib is usually given continuously at a dose of 37.5mg (3 pills) daily either alone or in combination with chemotherapy. However, there are studies which have shown that the continuous administration of sunitinib may reduce chemotherapy effectiveness. On the other hand, a short course of sunitinib before each chemotherapy cycle may sensitize the tumor to chemotherapy. This treatment strategy will be used in patients with different kinds of cancers with a commonly used chemotherapy drug, docetaxel. Ths study aims to evaluate if intermittent administration of low dose sunitinib before docetaxel chemotherapy can improve the treatment response in cancer patients.

Study Hypothesis: Low dose, short course sunitinib at 12.5mg daily orally for 1 week prior to chemotherapy can normalize tumor vasculature and enhance delivery of chemotherapy into the tumor, and improve treatment response and progression-free survival.

Conditions

Interventions

DRUG

Docetaxel

Docetaxel 75mg/m2 day 1, every 3 weeks

DRUG

Sunitinib

7 days of sunitinib 12.5mg orally daily during each cycle

Sponsors & Collaborators

  • National University Hospital, Singapore

    lead OTHER

Principal Investigators

  • Soo Chin Lee, MBBS · National University Hospital, Singapore

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
99 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-05-31
Primary Completion
2017-04-30
Completion
2018-04-30

Countries

  • Singapore

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01803503 on ClinicalTrials.gov