Solid TumorsPhase 2NCT01803503
Docetaxel With or Without Low-dose, Short Course Sunitinib in Refractory Solid Tumors
A Phase 2 study testing Docetaxel and Sunitinib in people with Solid Tumors and Breast Cancer, run by National University Hospital, Singapore at 2 sites in Singapore.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 99 years, women only
- Conditions the study is for
- Solid Tumors, Breast Cancer, Non-small Cell Lung Cancer
- What is being tested?
- Docetaxel and Sunitinib
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 2 sitesSingapore
- Study dates
- May 2013to Apr 2018
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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:
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- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
2 sites in 1 country.
Singapore2 sites, 2 recruiting
- Recruiting
National University Hospital
Singapore, Singapore, 119228
Soo Chin Lee, MBBS, +65 6779 5555, soo_chin_lee@nuhs.edu.sg
Soo Chin Lee, MBBS
- Not yet recruiting
National University Hospital
Singapore, 119074
Soo Chin Lee, MBBS, (65) 6779 5555, soo_chin_lee@nuhs.edu.sg
Soo Chin Lee, MBBS
About this study
Official title: Phase II Randomized Study of Docetaxel With or Without Low-dose, Short Course Sunitinib in the Treatment of Advanced Solid Tumors
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.
- Medical subject headings
- Breast Neoplasms, Carcinoma, Non-Small-Cell Lung, Prostatic Neoplasms, Stomach Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DocetaxelDrug
Docetaxel 75mg/m2 day 1, every 3 weeks
SunitinibDrug
7 days of sunitinib 12.5mg orally daily during each cycle
| Study group | Role | What they receive |
|---|---|---|
| Docetaxel | Active comparator | 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. Receives: Drug: Docetaxel |
| Docetaxel + Sunitinib | Experimental | 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. Receives: Drug: Docetaxel; Drug: Sunitinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective response rate
Measured: 18 weeks
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.
Measured: 18 weeks
Secondary outcomes (1)
Progression-free survival
Measured: 18 weeks until documented disease progression
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2013 (estimated)
- Study startMay 2013
- Primary completionApr 2017 (estimated)
- Study completionApr 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Solid TumorsStudies of the same condition, open and under way.
- More trials run by National University Hospital, SingaporeThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National University Hospital, Singapore
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Soo Chin Lee, MBBS, Principal investigator, National University Hospital, Singapore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01803503
- Sponsor's protocol ID
- BR01/08/13
- Other IDs
- 2013/00170
- Status last verified
- Jun 2016
- First submitted
- 1 Mar 2013
- Last updated
- 22 Jun 2016
- Results posted
- No
- Data monitoring committee
- No
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 22331954Ang 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
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Randomized Study of Docetaxel With or Without Low-dose, Short Course Sunitinib in the Treatment of Advanced Solid Tumors
- ClinicalTrials.gov ID
- NCT01803503
- Acronym / sponsor ID
- BR01/08/13
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- National University Hospital, SingaporeUniversity, hospital or other
- Study start
- May 2013
- Primary completion
- Apr 2017 (estimated)
- Study completion
- Apr 2018 (estimated)
- First posted
- 4 Mar 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Docetaxel | Active comparator | Drug: DocetaxelDocetaxel 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. |
| Docetaxel + Sunitinib | Experimental | Drug: Docetaxel, Drug: SunitinibDocetaxel 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. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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.
Key exclusion criteria (15 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DocetaxelDocetaxel 75mg/m2 day 1, every 3 weeks | Drug | Docetaxel, Docetaxel + Sunitinib |
| Sunitinib7 days of sunitinib 12.5mg orally daily during each cycle | Drug | Docetaxel + Sunitinib |
Primary outcome
Objective response rate
Time frame: 18 weeks
Clinical benefit rate
Time frame: 18 weeks
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.
1 secondary outcome
Progression-free survival
Time frame: 18 weeks until documented disease progression
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2016.
- Background: PubMed 22331954Bergh 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.
- Derived from this study: PubMed 33203399Ang 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Soo Chin Lee, MBBS principal investigator
National University Hospital, Singapore
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Docetaxel and Sunitinib in people with Solid Tumors and Breast Cancer, run by National University Hospital, Singapore at 2 sites in Singapore.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 Jun 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Singapore. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Soo Chin Lee, MBBS ((65) 6772 4629, soo_chin_lee@nuhs.edu.sg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective response rate (time frame: 18 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01803503, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jun 2016.