Gastric CancerPhase 2NCT00683787
Docetaxel With or Without Vandetanib in Treating Patients With Metastatic Stomach Cancer or Gastroesophageal Junction Cancer
A Phase 2 study testing docetaxel and vandetanib in people with Gastric Cancer, run by Roswell Park Cancer Institute at 1 site in United States.
Trial summary
RATIONALE: Drugs used in chemotherapy, such as docetaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Gastric Cancer
- What is being tested?
- docetaxel and vandetanib
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteUnited States
- Study dates
- May 2008to Mar 2011
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ECOG performance status 0-1
- Life expectancy ≥ 3 months
- ANC ≥ 1,500/µL
- Platelet count ≥ 100,000/µL
- Bilirubin ≤ 1.5 times upper limit of normal (ULN)
- Creatinine < 1.5 times ULN OR creatinine clearance ≥ 50 mL/min
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- Potassium ≥ 4.0 mEq/L (supplementation allowed) and ≤ the CTCAE grade 1 upper limit
- Magnesium normal (supplementation allowed) and ≤ the CTCAE grade 1 upper limit
- Calcium normal and corrected serum calcium ≤ the CTCAE grade 1 upper limit
- In cases where the serum calcium is below the normal range, calcium (adjusted for albumin) normal OR ionized calcium normal
- ALT and AST ≤ 2.5 times ULN
- Alkaline phosphatase ≤ 2.5 times ULN
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception during and for up to 12 weeks after completion of study therapy
- Atrial fibrillation allowed if controlled by medication
- LVEF ≥ 45% by MUGA or ECHO
Who cannot join
- Evidence of severe or uncontrolled systemic disease
- Any concurrent condition which makes it undesirable for the patient to participate in the trial or which would jeopardize study compliance, in the Investigator's opinion
- Uncontrolled infection
- Coagulopathy (including warfarin or anti-coagulant related) or bleeding disorder
- Peripheral neuropathy ≥ grade 2
- Clinically significant cardiac event, including myocardial infarction or New York Heart Association class II-IV heart disease within the past 3 months
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- Presence of cardiac disease that, in the opinion of the Investigator, increases the risk of ventricular arrhythmia
- History of arrhythmia (i.e., multifocal premature ventricular contractions, bigeminy, trigeminy, ventricular tachycardia, or uncontrolled atrial fibrillation) which is symptomatic or requires treatment (CTCAE grade 3) OR asymptomatic sustained ventricular tachycardia
- History of QTc prolongation as a result of other medication that required discontinuation of that medication
- Congenital long QT syndrome or a first degree relative with unexplained sudden death under 40 years of age
- Presence of left bundle branch block
- QTc with Bazett's correction that is unmeasurable or ≥ 480 msec on screening ECG
- If a patient has QTc ≥ 480 msec on screening ECG, the screen ECG may be repeated twice (at least 24 hours apart)
- The average OTc from the three screening ECGs must be < 480 msec in order for the patient to be eligible for the study
- Hypertension not controlled by medical therapy (systolic blood pressure [BP] > 160 mm Hg or diastolic BP > 100 mm Hg)
- Currently active diarrhea (≥ grade 2) that may affect the ability of the patient to absorb vandetanib
- Previous or current malignancies of other histologies within the past 5 years, with the exception of cervical carcinoma in situ and adequately treated basal cell or squamous cell carcinoma of the skin
- PRIOR CONCURRENT THERAPY:
- Recovered from all prior therapy
- At least 4 weeks since prior chemotherapy or radiotherapy
- No more than one prior chemotherapy regimen for metastatic disease
- Prior adjuvant therapy, including chemoradiotherapy, allowed
- At least 2 weeks since prior palliative radiotherapy
- Up to 3750 cGy palliative radiotherapy to the stomach allowed
- No prior therapy with docetaxel
- More than 30 days since prior investigational agents
- More than 4 weeks since prior and no concurrent or planned participation in another experimental drug study
- More than 4 weeks since prior major surgery and recovered
- More than 2 weeks since prior and no concurrent medication that may cause QTc prolongation or induce Torsades de Pointes
- No concurrent amiodarone
- No concurrent potent inducers of CYP3A4 function (e.g., rifampicin, rifabutin, phenytoin, carbamazepine, barbiturates, or Hypericum perforatum [St. John wort])
- No prior enrollment or randomization to treatment in the present study
Trial locations and contacts
1 site in 1 country.
United States1 site
Roswell Park Cancer Institute
Buffalo, New York, 14263-0001
About this study
Official title: Multicenter Randomized Phase II Trial of Docetaxel With/Without VANDETANIB for Advanced Gastroesophageal Cancer
RATIONALE: Drugs used in chemotherapy, such as docetaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Vandetanib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor. It is not yet known whether docetaxel is more effective when given together with or without vandetanib.
PURPOSE: This randomized phase II trial is studying docetaxel to see how well it works compared with docetaxel given together with vandetanib in treating patients with metastatic stomach cancer or gastroesophageal junction cancer.
Read the detailed description
OBJECTIVES:
Primary
- To test the hypothesis that the addition of a targeted agent, such as vandetanib, to standard chemotherapy with docetaxel will result in incremental responses in patients with metastatic gastric or gastroesophageal junction cancer.
Secondary
- To assess progression-free survival and overall survival of patients treated with this regimen.
- To study the toxicity profile of this regimen in these patients.
OUTLINE: This is a multicenter study. Patients are stratified according to clinical site. Patients are randomized to 1 of 3 treatment arms.
- Arm I: Patients receive docetaxel IV once every 3 weeks.
- Arm II: Patients receive docetaxel IV as in arm I and oral vandetanib (100 mg) once daily.
- Arm III: Patients receive docetaxel IV as in arm I and oral vandetanib (300 mg) once daily.
In all arms, courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed every 2 months for 5 years.
- Conditions
- Gastric Cancer
- Being tested
- docetaxel, vandetanib
- Keywords
- recurrent gastric cancer, stage IV gastric cancer, adenocarcinoma of the stomach
- Medical subject headings
- Stomach Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
docetaxelDrug
Given IV once every 3 weeks
vandetanibDrug
Oral vandetanib once daily
| Study group | Role | What they receive |
|---|---|---|
| Arm I | Active comparator | Patients receive docetaxel IV once every 3 weeks. Receives: Drug: docetaxel |
| Arm II | Experimental | Patients receive docetaxel IV as in arm I and oral vandetanib (100 mg) once daily. Receives: Drug: docetaxel; Drug: vandetanib |
| Arm III | Experimental | Patients receive docetaxel IV as in arm I and oral vandetanib (300 mg) once daily. Receives: Drug: docetaxel; Drug: vandetanib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Response Rate
Measured: 1 year
Secondary outcomes (3)
Progression-free Survival
Measured: 3 years
Overall Survival
Measured: 3 years
Toxicity
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 May 2008 (estimated)
- Study startMay 2008
- Primary completionApr 2009
- Study completionMar 2011
Why it stopped: low accrual
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.
- Other trials for Gastric CancerStudies of the same condition, open and under way.
- More trials run by Roswell Park Cancer InstituteThe 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
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Roswell Park Cancer Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nikhil Khushalani, MD, Principal investigator, Roswell Park Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00683787
- Sponsor's protocol ID
- CDR0000596150
- Other IDs
- RPCI-I-106207
- Status last verified
- Dec 2014
- First submitted
- 21 May 2008
- Last updated
- 8 Jan 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 8 Jan 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter Randomized Phase II Trial of Docetaxel With/Without VANDETANIB for Advanced Gastroesophageal Cancer
- ClinicalTrials.gov ID
- NCT00683787
- Acronym / sponsor ID
- CDR0000596150
- Conditions
- Gastric Cancer
- Keywords
- recurrent gastric cancer, stage IV gastric cancer, adenocarcinoma of the stomach
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: low accrual
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Roswell Park Cancer InstituteUniversity, hospital or other
- Study start
- May 2008
- Primary completion
- Apr 2009 (actual)
- Study completion
- Mar 2011 (actual)
- First posted
- 23 May 2008 (estimated)
- Results
- Posted 8 Jan 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
RATIONALE: Drugs used in chemotherapy, such as docetaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Vandetanib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor. It is not yet known whether docetaxel is more effective when given together with or without vandetanib.
PURPOSE: This randomized phase II trial is studying docetaxel to see how well it works compared with docetaxel given together with vandetanib in treating patients with metastatic stomach cancer or gastroesophageal junction cancer.
Detailed description
OBJECTIVES:
Primary
- To test the hypothesis that the addition of a targeted agent, such as vandetanib, to standard chemotherapy with docetaxel will result in incremental responses in patients with metastatic gastric or gastroesophageal junction cancer.
Secondary
- To assess progression-free survival and overall survival of patients treated with this regimen.
- To study the toxicity profile of this regimen in these patients.
OUTLINE: This is a multicenter study. Patients are stratified according to clinical site. Patients are randomized to 1 of 3 treatment arms.
- Arm I: Patients receive docetaxel IV once every 3 weeks.
- Arm II: Patients receive docetaxel IV as in arm I and oral vandetanib (100 mg) once daily.
- Arm III: Patients receive docetaxel IV as in arm I and oral vandetanib (300 mg) once daily.
In all arms, courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed every 2 months for 5 years.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Arm I | Active comparator | Drug: docetaxelPatients receive docetaxel IV once every 3 weeks. |
| Arm II | Experimental | Drug: docetaxel, Drug: vandetanibPatients receive docetaxel IV as in arm I and oral vandetanib (100 mg) once daily. |
| Arm III | Experimental | Drug: docetaxel, Drug: vandetanibPatients receive docetaxel IV as in arm I and oral vandetanib (300 mg) once daily. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- ECOG performance status 0-1
- Life expectancy ≥ 3 months
- ANC ≥ 1,500/µL
- Platelet count ≥ 100,000/µL
- Bilirubin ≤ 1.5 times upper limit of normal (ULN)
Key exclusion criteria (32 listed)
- Evidence of severe or uncontrolled systemic disease
- Any concurrent condition which makes it undesirable for the patient to participate in the trial or which would jeopardize study compliance, in the Investigator's opinion
- Uncontrolled infection
- Coagulopathy (including warfarin or anti-coagulant related) or bleeding disorder
- Peripheral neuropathy ≥ grade 2
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 |
|---|---|---|
| docetaxelGiven IV once every 3 weeks | Drug | Arm I, Arm II, Arm III |
| vandetanibOral vandetanib once daily | Drug | Arm II, Arm III |
Primary outcome
Overall Response Rate
Time frame: 1 year
3 secondary outcomes
Progression-free Survival
Time frame: 3 years
Overall Survival
Time frame: 3 years
Toxicity
Time frame: 1 year
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jan 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Nikhil Khushalani, MD principal investigator
Roswell Park Cancer Institute
1 site 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 vandetanib in people with Gastric Cancer, run by Roswell Park Cancer Institute at 1 site 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 17 inclusion and 32 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: stopped early, as of the sponsor's last update on 8 Jan 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 8 Jan 2015). 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?
Overall Response Rate (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 8 Jan 2015.