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| ID | Type | Description | Link |
|---|---|---|---|
| 2013/00170 | Other Identifier | NHG Domain Specific Review Boards |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Docetaxel | Drug | Docetaxel 75mg/m2 day 1, every 3 weeks |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Objective response rate | 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. | 18 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Progression-free survival | 18 weeks until documented disease progression |
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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:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Soo Chin Lee, MBBS | Contact | (65) 6772 4629 | soo_chin_lee@nuhs.edu.sg | |
| Christine Vergara, BS Bio & RN | Contact | (65) 6772 4619 | christine_vergara@nuhs.edu.sg |
| Name | Affiliation | Role |
|---|---|---|
| Soo Chin Lee, MBBS | National University Hospital, Singapore | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| National University Hospital | Recruiting | Singapore | Singapore | 119228 | Singapore |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22331954 | Background | 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. | |
| 33203399 |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| D002289 | Carcinoma, Non-Small-Cell Lung |
| D011471 | Prostatic Neoplasms |
| D013274 | Stomach Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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| ID | Term |
|---|---|
| D000077143 | Docetaxel |
| D000077210 | Sunitinib |
| ID | Term |
|---|---|
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
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| Sunitinib |
| Drug |
7 days of sunitinib 12.5mg orally daily during each cycle |
|
| National University Hospital | Not yet recruiting | Singapore | 119074 | Singapore |
|
| Derived |
| 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. |
| D017437 |
| Skin and Connective Tissue Diseases |
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D013272 | Stomach Diseases |
| D006844 |
| Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D004224 | Diterpenes |
| D013729 | Terpenes |
| D011758 | Pyrroles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |