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Status unknownNCT01803503Updated Jun 22, 2016

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

A Phase 2 interventional study of Docetaxel and Sunitinib in Solid Tumors, Breast Cancer and Non-small Cell Lung Cancer, sponsored by National University Hospital, Singapore. Status unknown at 2 sites in Singapore. Open to female participants aged 18 Years to 99 Years. Per ClinicalTrials.gov, last updated 2016-06-22.

Sponsored by National University Hospital, Singapore · Phase 2, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Jun 2016), so the status shown — last known as Recruiting — may be out of date.
Phase
Phase 2
Study type
Interventional
Enrollment
80
Allocation
Randomized
Ages
18 Years to 99 Years
Sex
Female
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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.

Read the detailed description

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.

02

Conditions studied

  • Solid Tumors
  • Breast Cancer
  • Non-small Cell Lung Cancer
  • Prostate Cancer
  • Gastric Cancer
03

In context

Carcinoma, Non-Small-Cell Lung

6,488 studies on the registry are indexed under Carcinoma, Non-Small-Cell Lung; 1,632 are open to participants now.

This study's planned enrollment of 80 is above the median of 62 across 5,213 interventional studies indexed under Carcinoma, Non-Small-Cell Lung.

Browse Carcinoma, Non-Small-Cell Lung studies →

Lead sponsor

National University Hospital, Singapore is the lead sponsor of 444 studies on the registry; 96 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 99 Years
Sexes eligible
Female
Accepts healthy volunteers
No

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

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 investigator.
  • 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 dementia.
  • 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.
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Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
80 participants (estimated)

Study arms

  • Active comparator
    Docetaxel

    Docetaxel 75mg/m2 day 1, every 3 weeks. Patients will be treated for a maximum of 6 cycles of chemotherapy in the absence of tumor progression or unacceptable toxicities.

    Drug: Docetaxel

  • Experimental
    Docetaxel + Sunitinib

    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.

    Drug: Docetaxel · Drug: Sunitinib

Interventions

  • DrugDocetaxel

    Docetaxel 75mg/m2 day 1, every 3 weeks

  • DrugSunitinib

    7 days of sunitinib 12.5mg orally daily during each cycle

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What researchers measure

Primary outcomes

  1. Objective response rate

    Time frame: 18 weeks

  2. Clinical benefit rate

    Clinical benefit rate is defined as the proportion of patients who achieved complete response, partial response, or stable disease for at least 12 weeks, as the best response.

    Time frame: 18 weeks

Secondary outcomes

  1. Progression-free survival

    Time frame: 18 weeks until documented disease progression

07

Study locations

1 of 2 sites recruiting
  • National University Hospital
    Singapore, 119074, Singapore
    Not yet recruiting
  • National University Hospital
    Singapore, 119228, Singapore
    Recruiting
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References and documents

Publications

  • Bergh J, Bondarenko IM, Lichinitser MR, Liljegren A, Greil R, Voytko NL, Makhson AN, Cortes J, Lortholary A, Bischoff J, Chan A, Delaloge S, Huang X, Kern KA, Giorgetti C. First-line treatment of advanced breast cancer with sunitinib in combination with docetaxel versus docetaxel alone: results of a prospective, randomized phase III study. J Clin Oncol. 2012 Mar 20;30(9):921-9. doi: 10.1200/JCO.2011.35.7376. Epub 2012 Feb 13. PubMed 22331954 ↗
  • Ang YLE, Ho GF, Soo RA, Sundar R, Tan SH, Yong WP, Ow SGW, Lim JSJ, Chong WQ, Soe PP, Tai BC, Wang L, Goh BC, Lee SC. A randomized phase II trial evaluating the addition of low dose, short course sunitinib to docetaxel in advanced solid tumours. BMC Cancer. 2020 Nov 17;20(1):1118. doi: 10.1186/s12885-020-07616-4. PubMed 33203399 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 22, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT01803503
Lead sponsor
National University Hospital, Singapore
Responsible party
Sponsor
First posted
Mar 4, 2013
Start date
May 2013
Primary completion
Apr 2017 (estimated)
Completion
Apr 2018 (estimated)
Last update
Jun 22, 2016

Study contacts

Soo Chin Lee, MBBS
Contact
soo_chin_lee@nuhs.edu.sg
(65) 6772 4629
Christine Vergara, BS Bio & RN
Contact
christine_vergara@nuhs.edu.sg
(65) 6772 4619
Soo Chin Lee, MBBS
principal investigator · National University Hospital, Singapore

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jun 2016. You cannot join it, but the record below documents what was studied.

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