Esophageal CancerPhase 2NCT00730353
Sutent + Taxol for Advanced Esophageal Cancer
A Phase 2 study testing Sunitinib malate and Paclitaxel in people with Esophageal Cancer, run by Hoosier Cancer Research Network at 15 sites in United States.
Trial summary
Paclitaxel is known to be active as a single and combination agent in esophageal cancer, and has also been demonstrated to have anti-angiogenic properties in weekly dosing regimens. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Esophageal Cancer
- What is being tested?
- Sunitinib malate and Paclitaxel
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 15 sitesUnited States
- Study dates
- Aug 2008to Mar 2010
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically confirmed recurrent or metastatic esophageal or gastro-esophageal junction squamous cell or adenocarcinoma
- Measurable or evaluable disease per RECIST within 28 days prior to being registered on protocol therapy.
- No more than one prior chemotherapy regimen for locally advanced or metastatic disease is allowed.
- Written informed consent and HIPAA authorization for release of personal health information. NOTE: HIPAA authorization may be included in the informed consent or obtained separately.
- Age > 18 years.
- Females of childbearing potential and males must be willing to use an effective method of contraception (hormonal or barrier method of birth control; abstinence) while on treatment and for 3 month period thereafter.
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- Females of childbearing potential must have a negative pregnancy test within 7 days prior to being registered for protocol therapy. Subjects are considered not of child bearing potential if they are surgically sterile (they have undergone a hysterectomy, bilateral tubal ligation, or bilateral oophorectomy) or they are postmenopausal.
- Females must not be breastfeeding.
- Must be willing to comply with study and follow up procedures.
Who cannot join
- No history of inadequately controlled hypertension (Systolic Blood Pressure > 150 or Diastolic Blood Pressure > 100) on a standard regimen of antihypertensive therapy.
- No prior treatment with vascular endothelial growth factor (VEGF) inhibitor, epidermal growth factor receptor (EGFR) inhibitor, or other anti-angiogenic agent.
- No serious, non-healing wound, ulcer, or bone fracture.
- No history of or current hemoptysis.
- No history of transient ischemic attack (TIA) or stroke within 12 months prior to registration for protocol therapy.
- No evidence of bleeding diathesis, coagulopathy, prolonged INR or PTT.
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- No chronic anti-coagulation treatment.
- No history of central nervous system or brain metastases.
- No history of any major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to registration for protocol therapy, or anticipation of need for major surgical procedure during the course of protocol therapy.
- No history of any minor surgical procedures such as fine needle aspirations or core biopsies within 7 days prior to registration for protocol therapy.
- No history of clinically significant peripheral neuropathy, i.e., Grade > 3 neuromotor or neurosensory toxicity as defined by NCI CTCAE v 3.0.
- No known history of adrenal insufficiency documented by adrenocorticotropic hormone (ACTH) stimulation testing.
- No prolonged corrected QT (QTc) interval on pre-entry electrocardiogram (> 450 msec), obtained within 28 days prior to being registered for protocol therapy.
- No other active cancers
- No clinically significant infections as judged by the treating investigator.
- No history of a seizure disorder.
- No known history of hypersensitivity to paclitaxel.
- No CYP3A4 inducers and inhibitors allowed within 14 days prior to registration on protocol therapy and while receiving the protocol therapy.
Trial locations and contacts
15 sites in 1 country.
15 sites in 1 country
United States15 sites
Cancer Care Center of Southern Indiana
Bloomington, Indiana, 47403
Northwestern University Feinberg School of Medicine
Chicago, Illinois, 60611
Rush-Presbyterian St. Luke's Medical Center
Chicago, Illinois, 60612
Ireland Cancer Center - University Hospitals of Cleveland
Cleveland, Ohio, 44106
Oncology Hematology Associates of SW Indiana
Evansville, Indiana, 47714
Fort Wayne Oncology & Hematology, Inc
Fort Wayne, Indiana, 46815
Medical & Surgical Specialists, LLC
Galesburg, Illinois, 61401
IN Onc/Hem Associates
Indianapolis, Indiana, 46202
Indiana University Simon Cancer Center
Indianapolis, Indiana, 46202
Arnett Cancer Care
Lafayette, Indiana, 47904
Horizon Oncology Center
Lafayette, Indiana, 47905
Medical Consultants, P.C.
Muncie, Indiana, 47303
Monroe Medical Associates
Munster, Indiana, 46321
Northern Indiana Cancer Research Consortium
South Bend, Indiana, 46601
Providence Medical Group
Terre Haute, Indiana, 47802
About this study
Official title: A Phase II Study of Sunitinib Malate (Sutent®) With Paclitaxel (Taxol®) in Patients With Advanced Esophageal Cancer
Paclitaxel is known to be active as a single and combination agent in esophageal cancer, and has also been demonstrated to have anti-angiogenic properties in weekly dosing regimens. Sunitinib malate is an anti-angiogenic drug with the potential to improve responses when combined with chemotherapy, as demonstrated with other regimens in similar settings. We believe that the combination of paclitaxel and sunitinib malate offer great promise in the treatment of advanced esophageal cancer.
Read the detailed description
OUTLINE: This is a multi-center study.
Treatment will be administered on an outpatient basis. Chemotherapy will be administered in a 28-day treatment cycle. The 28 days of treatment with paclitaxel and sunitinib malate (plus the time required to recover if toxicity is encountered) is defined as a cycle.
- Paclitaxel 90 mg/m2 IV on days 1, 8 and 15.
- Sunitinib malate 37.5 mg orally, daily.
After 4 cycles, paclitaxel will be discontinued and patients will continue on sunitinib malate until disease progression, unacceptable toxicity, or physician discretion.
Performance Status: ECOG (Eastern Cooperative Oncology Group) performance status 0 to 2
Life expectancy: Not specified
Hematopoietic:
- International Normalized Ratio (INR) < 1.2
- Partial Thromboplastin Time (PTT) < 1.5 x Upper Limit of Normal (ULN)
- Platelets > 100 K/mm3
- Hemoglobin > 8 g/dL
- Absolute Neutrophil Count (ANC) > 1.0 K/mm3
Hepatic:
- Aspartate transaminase (AST) ≤ 2.5 x ULN, or ≤ 5.0 x ULN if the transaminase elevation is due to known liver metastases.
- Alanine transaminase (ALT) ≤ 2.5 x ULN, or ≤ 5.0 x ULN if the transaminase elevation is due to known liver metastases.
- Total bilirubin < 2.0 x ULN
Renal:
- Serum creatinine ≤ 2 x ULN or a calculated creatinine clearance (using Cockcroft-Gault formula) > 50 cc/min
Cardiovascular:
- No history of unstable angina, myocardial infarction, coronary artery bypass grafting surgery within 12 months prior to registration for protocol therapy. Patients may be on anti-anginal medications, but must be stable on those medications for at least 6 months.
- No history of New York Heart Association class II or greater congestive heart failure.
Pulmonary:
- Not specified
- Conditions
- Esophageal Cancer
- Being tested
- Sunitinib malate, Paclitaxel
- Medical subject headings
- Esophageal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sunitinib malateDrug
Sunitinib malate 37.5 mg orally, daily
PaclitaxelDrug
Paclitaxel 90 mg/m2 IV on days 1, 8 and 15.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Treatment will be administered on an outpatient basis. Chemotherapy will be administered in a 28-day treatment cycle. The 28 days of treatment with paclitaxel and sunitinib malate (plus the time required to recover if toxicity is encountered) is defined as a cycle.
* Paclitaxel 90 mg/m2 IV on days 1, 8 and 15.
* Sunitinib malate 37.5 mg orally, daily. After 4 cycles, paclitaxel will be discontinued and patients will continue on sunitinib malate until disease progression, unacceptable toxicity, or physician discretion. Receives: Drug: Sunitinib malate; Drug: Paclitaxel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression Free Survival Rate at 24 Weeks
To determine the rate of non-progressive disease at 24 weeks from the first dose of the combination of sunitinib malate and paclitaxel in advanced esophageal carcinoma, where progression is defined as at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions
Measured: 24 weeks
Secondary outcomes (4)
Response Rate
To determine the response rate for the combination of sunitinib malate and paclitaxel in advanced esophageal carcinoma per RECIST criteria.
Measured: 6 months
Overall Survival
To determine the one year overall survival rate for the combination of sunitinib malate and paclitaxel in advanced esophageal carcinoma
Measured: 12 months
Progression-Free Survival
To determine the time to progression for the combination of sunitinib malate and paclitaxel in advanced esophageal carcinoma per RECIST criteria.
Measured: 12 months
Toxicity Profile
Determine the most frequent toxicities associated with the treatment regimen, per the CTCAE version 3 (Common Toxicity Criteria for Adverse Events) criteria.
Measured: 16 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2008 (estimated)
- Study startAug 2008
- Primary completionMar 2010
- Study completionMar 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Esophageal CancerStudies of the same condition, open and under way.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hoosier Cancer Research Network
- Sponsor type
- University, hospital or other
- Collaborators
- Pfizer
- Responsible party
- Principal investigator, Nasser Hanna, M.D., Hoosier Cancer Research Network
- Investigators
- Nasser Hanna, M.D., Study chair, Hoosier Cancer Research Network
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00730353
- Sponsor's protocol ID
- HOG GI06-112
- Status last verified
- Jan 2017
- First submitted
- 4 Aug 2008
- Last updated
- 16 Mar 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Schmitt JM, Sommers SR, Fisher W, Ansari R, Robin E, Koneru K, McClean J, Liu Z, Tong Y, Hanna N. Sunitinib plus paclitaxel in patients with advanced esophageal cancer: a phase II study from the Hoosier Oncology Group. J Thorac Oncol. 2012 Apr;7(4):760-3. doi: 10.1097/JTO.0b013e31824abc7c.
PubMed 22425927
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Study of Sunitinib Malate (Sutent®) With Paclitaxel (Taxol®) in Patients With Advanced Esophageal Cancer
- ClinicalTrials.gov ID
- NCT00730353
- Acronym / sponsor ID
- HOG GI06-112
- Conditions
- Esophageal Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Hoosier Cancer Research NetworkUniversity, hospital or other
- Collaborators
- Pfizer
- Study start
- Aug 2008
- Primary completion
- Mar 2010 (actual)
- Study completion
- Mar 2010 (actual)
- First posted
- 8 Aug 2008 (estimated)
- Results
- Posted 16 Mar 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Paclitaxel is known to be active as a single and combination agent in esophageal cancer, and has also been demonstrated to have anti-angiogenic properties in weekly dosing regimens. Sunitinib malate is an anti-angiogenic drug with the potential to improve responses when combined with chemotherapy, as demonstrated with other regimens in similar settings. We believe that the combination of paclitaxel and sunitinib malate offer great promise in the treatment of advanced esophageal cancer.
Detailed description
OUTLINE: This is a multi-center study.
Treatment will be administered on an outpatient basis. Chemotherapy will be administered in a 28-day treatment cycle. The 28 days of treatment with paclitaxel and sunitinib malate (plus the time required to recover if toxicity is encountered) is defined as a cycle.
- Paclitaxel 90 mg/m2 IV on days 1, 8 and 15.
- Sunitinib malate 37.5 mg orally, daily.
After 4 cycles, paclitaxel will be discontinued and patients will continue on sunitinib malate until disease progression, unacceptable toxicity, or physician discretion.
Performance Status: ECOG (Eastern Cooperative Oncology Group) performance status 0 to 2
Life expectancy: Not specified
Hematopoietic:
- International Normalized Ratio (INR) < 1.2
- Partial Thromboplastin Time (PTT) < 1.5 x Upper Limit of Normal (ULN)
- Platelets > 100 K/mm3
- Hemoglobin > 8 g/dL
- Absolute Neutrophil Count (ANC) > 1.0 K/mm3
Hepatic:
- Aspartate transaminase (AST) ≤ 2.5 x ULN, or ≤ 5.0 x ULN if the transaminase elevation is due to known liver metastases.
- Alanine transaminase (ALT) ≤ 2.5 x ULN, or ≤ 5.0 x ULN if the transaminase elevation is due to known liver metastases.
- Total bilirubin < 2.0 x ULN
Renal:
- Serum creatinine ≤ 2 x ULN or a calculated creatinine clearance (using Cockcroft-Gault formula) > 50 cc/min
Cardiovascular:
- No history of unstable angina, myocardial infarction, coronary artery bypass grafting surgery within 12 months prior to registration for protocol therapy. Patients may be on anti-anginal medications, but must be stable on those medications for at least 6 months.
- No history of New York Heart Association class II or greater congestive heart failure.
Pulmonary:
- Not specified
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: Sunitinib malate, Drug: PaclitaxelTreatment will be administered on an outpatient basis. Chemotherapy will be administered in a 28-day treatment cycle. The 28 days of treatment with paclitaxel and sunitinib malate (plus the time required to recover if toxicity is encountered) is defined as a cycle. * Paclitaxel 90 mg/m2 IV on days 1, 8 and 15. * Sunitinib malate 37.5 mg orally, daily. After 4 cycles, paclitaxel will be discontinued and patients will continue on sunitinib malate until disease progression, unacceptable toxicity, or physician discretion. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Histologically confirmed recurrent or metastatic esophageal or gastro-esophageal junction squamous cell or adenocarcinoma
- Measurable or evaluable disease per RECIST within 28 days prior to being registered on protocol therapy.
- No more than one prior chemotherapy regimen for locally advanced or metastatic disease is allowed.
- Written informed consent and HIPAA authorization for release of personal health information. NOTE: HIPAA authorization may be included in the informed consent or obtained separately.
- Age > 18 years.
Key exclusion criteria (18 listed)
- No history of inadequately controlled hypertension (Systolic Blood Pressure > 150 or Diastolic Blood Pressure > 100) on a standard regimen of antihypertensive therapy.
- No prior treatment with vascular endothelial growth factor (VEGF) inhibitor, epidermal growth factor receptor (EGFR) inhibitor, or other anti-angiogenic agent.
- No serious, non-healing wound, ulcer, or bone fracture.
- No history of or current hemoptysis.
- No history of transient ischemic attack (TIA) or stroke within 12 months prior to registration for protocol therapy.
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 |
|---|---|---|
| Sunitinib malateSunitinib malate 37.5 mg orally, daily | Drug | 1 |
| PaclitaxelPaclitaxel 90 mg/m2 IV on days 1, 8 and 15. | Drug | 1 |
Primary outcome
Progression Free Survival Rate at 24 Weeks
Time frame: 24 weeks
To determine the rate of non-progressive disease at 24 weeks from the first dose of the combination of sunitinib malate and paclitaxel in advanced esophageal carcinoma, where progression is defined as at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions
4 secondary outcomes
Response Rate
Time frame: 6 months
Overall Survival
Time frame: 12 months
Progression-Free Survival
Time frame: 12 months
Toxicity Profile
Time frame: 16 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Mar 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 22425927Schmitt JM, Sommers SR, Fisher W, Ansari R, Robin E, Koneru K, McClean J, Liu Z, Tong Y, Hanna N. Sunitinib plus paclitaxel in patients with advanced esophageal cancer: a phase II study from the Hoosier Oncology Group. J Thorac Oncol. 2012 Apr;7(4):760-3. doi: 10.1097/JTO.0b013e31824abc7c.
- Hoosier Oncology Group HomepageLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
Nasser Hanna, M.D. study chair
Hoosier Cancer Research Network
15 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 Sunitinib malate and Paclitaxel in people with Esophageal Cancer, run by Hoosier Cancer Research Network at 15 sites in United States.
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 9 inclusion and 18 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: finished, as of the sponsor's last update on 16 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 sites in United States. 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?
Yes. Results are posted in the registry (first posted 16 Mar 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression Free Survival Rate at 24 Weeks (time frame: 24 weeks). 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 NCT00730353, which also lists 1 linked publication.
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 16 Mar 2017.