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Phase II Randomized Study of Docetaxel With or Without Low-dose, Short Course Sunitinib in the Treatment of Advanced Solid Tumors

Phase 2
18 Years
Open (Enrolling)
Solid Tumors, Breast Cancer, Non-small Cell Lung Cancer, Prostate Cancer, Gastric Cancer

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Trial Information

Phase II Randomized Study of Docetaxel With or Without Low-dose, Short Course Sunitinib in the Treatment of Advanced Solid Tumors

This is a single-centre, phase II randomized study. Eligible patients will be randomized to
docetaxel with or without intermittent sunitinib. A total of eighty patients with measurable
tumor will be enrolled over a period of 24-36 months. Eligible patients will be randomized
1:1 to either arm A or arm B. Patients will be stratified according to site of primary tumor
(breast vs non-small cell lung cancer vs others) for randomization purposes.

Arm A (Control arm):

Docetaxel 75mg/m2 day 1, every 3 weeks

Arm B (Experimental arm):

Docetaxel 75mg/m2 day 1, every 3 weeks, preceded by 7 days of sunitinib 12.5mg orally daily
during each cycle.

Patients will be treated for a maximum of 6 cycles of chemotherapy in the absence of tumor
progression or unacceptable toxicities.

Patient will be evaluated weekly for toxicity assessments and full blood count during cycle
1, and on days 1 and 15 of each subsequent cycle.

Inclusion Criteria:

- Age >= 18 years.

- Histologic or cytologic diagnosis of carcinoma.

- Measurable tumor, defined as clinically palpable tumor with both diameters 2.0cm or
greater as measured by caliper, or radiologically measurable tumor on CT scan with
the largest diameter >= 1cm.

- Eastern Cooperative Oncology Group 0-1

- Estimated life expectancy of at least 12 weeks.

- Adequate organ function including the following:

- Bone marrow: Absolute neutrophil (segmented and bands) count (ANC) >= 1.5 x 109/L
Platelets >= 100 x 109/L

- Hepatic: Bilirubin <= 1.5 x upper limit of normal (ULN), ALT or AST <= 2.5x ULN,
(or <=5x with liver metastases)

- Renal: Creatinine <= 1.5x ULN

- Signed informed consent from patient or legal representative.

- Patients with reproductive potential must use an approved contraceptive method if
appropriate (e.g., intrauterine device, birth control pills, or barrier device)
during and for three months after the study. Females with childbearing potential must
have a negative serum pregnancy test within 7 days prior to study enrollment.

Exclusion Criteria:

- Treatment within the last 28 days with any investigational drug.

- Concurrent administration of any other tumor therapy, including cytotoxic
chemotherapy, hormonal therapy, and immunotherapy.

- Major surgery within 28 days of study drug administration.

- Active infection that in the opinion of the investigator would compromise the
patient's ability to tolerate therapy.

- Pregnancy.

- Breast feeding.

- Serious concomitant disorders that would compromise the safety of the patient or
compromise the patient's ability to complete the study, at the discretion of the

- Active bleeding disorder or bleeding site.

- Non-healing wound.

- Poorly controlled diabetes mellitus.

- Second primary malignancy that is clinically detectable at the time of consideration
for study enrollment.

- Symptomatic brain metastasis.

- History of significant neurological or mental disorder, including seizures or

- Known history of systemic connective tissue diseases (e.g., systemic lupus
erythematosus, rheumatoid arthritis, systemic sclerosis), vasculities (e.g., giant
cell arteritis, Kawasaki disease, Wegener's granulomatosis, Churg-Strauss disease) or
sickle cell disease.

- Known history of renal impairment, defined as a Glomerular Filtration Rate (GFR) of
less than 30ml/minute.

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Objective response rate

Outcome Time Frame:

18 weeks

Safety Issue:


Principal Investigator

Soo Chin Lee, MBBS

Investigator Role:

Principal Investigator

Investigator Affiliation:

National University Hospital, Singapore


Singapore: Domain Specific Review Boards

Study ID:




Start Date:

May 2013

Completion Date:

April 2016

Related Keywords:

  • Solid Tumors
  • Breast Cancer
  • Non-Small Cell Lung Cancer
  • Prostate Cancer
  • Gastric Cancer
  • Breast Neoplasms
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms
  • Stomach Neoplasms
  • Prostatic Neoplasms
  • Neoplasms