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

Primary Purpose

Solid Tumors, Breast Cancer, Non-small Cell Lung Cancer

Status
Unknown status
Phase
Phase 2
Locations
Singapore
Study Type
Interventional
Intervention
Docetaxel
Sunitinib
Sponsored by
National University Hospital, Singapore
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Solid Tumors

Eligibility Criteria

18 Years - 99 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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 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.

Sites / Locations

  • National University Hospital
  • National University HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Docetaxel

Docetaxel + Sunitinib

Arm Description

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 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.

Outcomes

Primary Outcome Measures

Objective response rate
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.

Secondary Outcome Measures

Progression-free survival

Full Information

First Posted
March 1, 2013
Last Updated
June 21, 2016
Sponsor
National University Hospital, Singapore
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1. Study Identification

Unique Protocol Identification Number
NCT01803503
Brief Title
Docetaxel With or Without Low-dose, Short Course Sunitinib in Refractory Solid Tumors
Official Title
Phase II Randomized Study of Docetaxel With or Without Low-dose, Short Course Sunitinib in the Treatment of Advanced Solid Tumors
Study Type
Interventional

2. Study Status

Record Verification Date
June 2016
Overall Recruitment Status
Unknown status
Study Start Date
May 2013 (undefined)
Primary Completion Date
April 2017 (Anticipated)
Study Completion Date
April 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National University Hospital, Singapore

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Solid Tumors, Breast Cancer, Non-small Cell Lung Cancer, Prostate Cancer, Gastric Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Docetaxel
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Docetaxel + Sunitinib
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Docetaxel
Intervention Description
Docetaxel 75mg/m2 day 1, every 3 weeks
Intervention Type
Drug
Intervention Name(s)
Sunitinib
Intervention Description
7 days of sunitinib 12.5mg orally daily during each cycle
Primary Outcome Measure Information:
Title
Objective response rate
Time Frame
18 weeks
Title
Clinical benefit rate
Description
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 Outcome Measure Information:
Title
Progression-free survival
Time Frame
18 weeks until documented disease progression

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Soo Chin Lee, MBBS
Phone
(65) 6772 4629
Email
soo_chin_lee@nuhs.edu.sg
First Name & Middle Initial & Last Name or Official Title & Degree
Christine Vergara, BS Bio & RN
Phone
(65) 6772 4619
Email
christine_vergara@nuhs.edu.sg
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Soo Chin Lee, MBBS
Organizational Affiliation
National University Hospital, Singapore
Official's Role
Principal Investigator
Facility Information:
Facility Name
National University Hospital
City
Singapore
ZIP/Postal Code
119074
Country
Singapore
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Soo Chin Lee, MBBS
Phone
(65) 6779 5555
Email
soo_chin_lee@nuhs.edu.sg
First Name & Middle Initial & Last Name & Degree
Soo Chin Lee, MBBS
Facility Name
National University Hospital
City
Singapore
ZIP/Postal Code
119228
Country
Singapore
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Soo Chin Lee, MBBS
Phone
+65 6779 5555
Email
soo_chin_lee@nuhs.edu.sg
First Name & Middle Initial & Last Name & Degree
Soo Chin Lee, MBBS

12. IPD Sharing Statement

Citations:
PubMed Identifier
22331954
Citation
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.
Results Reference
background
PubMed Identifier
33203399
Citation
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.
Results Reference
derived

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

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