Ovarian CancerPhase 2NCT00768144
Sunitinib in Recurrent and Refractory Ovarian, Fallopian Tube and Peritoneal Carcinoma
A Phase 2 study testing Sunitinib in people with Ovarian Cancer and Fallopian Tube Cancer, run by Dana-Farber Cancer Institute at 3 sites in United States.
Trial summary
The purpose of this study is to determine the effectiveness of sunitinib on participants with ovarian, fallopian tube or peritoneal cancer. Sunitinib is a newly discovered drug that may stop cancer cells from growing by blocking the blood supply to the tumor. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ovarian Cancer, Fallopian Tube Cancer, Peritoneal Cancer
- What is being tested?
- Sunitinib
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 3 sitesUnited States
- Study dates
- Sep 2008to Feb 2013
- 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 or cytologically confirmed epithelial ovarian, fallopian tube or peritoneal cancer
- Recurrent or refractory disease
- Measurable disease, defined by RECIST
- 0 to 3 prior cytotoxic chemotherapy or biologic regimens for metastatic disease
- Adverse events related to prior tumor-specific therapy must have resolved to less than or equal to grade 1 prior to study entry
- Ability to swallow oral medications
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- 18 years of age or older
- ECOG Performance status must be 0-2
- Normal organ and marrow function as outlined in the protocol
Who cannot join
- Receiving systemic therapy less than 14 days prior to starting sunitinib
- Receiving any other investigational agent
- Received prior sunitinib
- Untreated brain metastases, spinal cord compression, or evidence of symptomatic brain metastases or leptomeningeal disease as noted on screening CT or MRI scans
- Any of the following within the 6 months prior to study drug administration: myocardial infarction, severe/unstable angina, coronary/peripheral artery bypass graft, symptomatic congestive heart failure, cerebrovascular accident or transient ischemic attack, or pulmonary embolism.
- Evidence of a bleeding diathesis. Major surgery or NCI CTCA 3.0 grade 3 or worse hemorrhage within 4 weeks of starting study treatment
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- Ongoing cardiac dysrhythmias of NCI CTCAE version 3.0 grade > 2
- Pre-existing thyroid abnormality, with thyroid function tests that cannot be maintained in the normal range with medication
- Prolonged QTc interval on baseline EKG
- Uncontrolled hypertension
- Patients who are taking cytochrome P450 enzyme-inducing antiepileptic drugs, rifampin, theophylline, ketoconazole, or St. John's wort.
- Psychiatric illness or social situations that wold limit compliance with study requirements
- Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or study drug administration
- Pregnant women
- Clinical or radiographical evidence of a small bowel obstruction
- Poor oral intake
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Dana-Farber Cancer Institute
Boston, Massachusetts, 02115
Massachusetts General Hospital
Boston, Massachusetts, 02214
Beth-Israel Deaconess Medical Center
Boston, Massachusetts, 02215
About this study
Official title: A Phase II Trial of Sunitinib in Recurrent and Refractory Ovarian, Fallopian Tube and Peritoneal Carcinoma
The purpose of this study is to determine the effectiveness of sunitinib on participants with ovarian, fallopian tube or peritoneal cancer. Sunitinib is a newly discovered drug that may stop cancer cells from growing by blocking the blood supply to the tumor.
Read the detailed description
This study used a two-stage design to evaluate efficacy of sunitinib based on overall response (OR) defined as complete response (CR) or partial response (PR). The null and alternative OR rate were 5% and 20%. If one or more patients enrolled in the stage one cohort (n=17 patients) achieved PR or better than accrual would proceed to stage two (n=18 patients). There was 42% probability of stopping the trial at stage one if the true OR rate was 5%. With 35 patients, this design had 85% power to detect the 15% difference in OR rates assuming 2-sided type I error rate of 0.05.
- Conditions
- Ovarian Cancer, Fallopian Tube Cancer, Peritoneal Cancer
- Being tested
- Sunitinib
- Keywords
- Sutent, sunitinib
- Medical subject headings
- Ovarian Neoplasms, Fallopian Tube Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SunitinibDrug
Also called Sutent
| Study group | Role | What they receive |
|---|---|---|
| Sunitinib | Experimental | Patients received oral Sunitinib at the daily dose of 37.5 mg continuously over a 28- day treatment cycle. Treatment continued until clinical or radiological evidence of progressive disease or excessive toxicity. Receives: Drug: Sunitinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Response Rate
Best response on treatment was based on RECIST 1.0 criteria with overall response defined as achieving partial response (PR) or complete response (CR). Per RECIST 1.0 for target lesions, CR is complete disappearance of all target lesions and PR is at least a 30% decrease in the sum of longest diameter (LD) of target lesions, taking as reference baseline sum LD. To be assigned a status of CR or PR, changes in tumor measurements must be confirmed by repeat assessments performed no fewer than 4 weeks after the response criteria are first met. PR or better overall response assumes at a minimum incomplete response/stable disease (SD) for the evaluation of non-target lesions and absence of new lesions.
Measured: Clinical assessments were performed weekly for first 4 weeks and every 2 wks in subsequent cycles. Disease was evaluated radiologically at baseline, before each odd cycle and at end of trt.
Secondary outcomes (2)
16-Week Progression-Free Survival
16-week progression-free survival is the probability of patients remaining alive and progression-free at 16-weeks from study entry estimated using Kaplan-Meier methods. Patients alive and progression-free at last follow-up are censored. Progressive disease (PD) based on RECIST 1.0 is at least a 20% increase in the sum of longest diameter (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. PD for the evaluation of non-target lesions is the appearance of one or more new lesions and/or equivocal progression of non-target lesions.
Measured: Clinical assessments were performed weekly for first 4 weeks and every 2 weeks in subsequent cycles. Disease was evaluated radiologically at baseline, before each odd cycle and at end of treatment.
Progression-Free Survival
Progression-free survival estimated using Kaplan-Meier methods is defined as the time from registration to the earlier of death or disease progression. Patients alive without disease progression are censored at the date of last disease evaluation. Progressive disease (PD) based on RECIST 1.0 is at least a 20% increase in the sum of longest diameter (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. Equivocal progression of non-target lesions also qualifies as PD.
Measured: Clinical assessments were performed weekly for first 4 weeks and every 2 weeks in subsequent cycles. Disease was evaluated radiologically at baseline, before each odd cycle and at end of treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Oct 2008 (estimated)
- Study startSep 2008
- Primary completionMay 2012
- Study completionFeb 2013
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 Ovarian CancerStudies of the same condition, open and under way.
- More trials run by Dana-Farber 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dana-Farber Cancer Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Beth Israel Deaconess Medical Center, Brigham and Women's Hospital, Massachusetts General Hospital
- Responsible party
- Principal investigator, Susana M. Campos, MD, Dana-Farber Cancer Institute
- Investigators
- Susana M. Campos, MD, Principal investigator, Dana-Farber Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00768144
- Sponsor's protocol ID
- 08-056
- Status last verified
- Jul 2018
- First submitted
- 29 Sep 2008
- Last updated
- 24 Aug 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Trial of Sunitinib in Recurrent and Refractory Ovarian, Fallopian Tube and Peritoneal Carcinoma
- ClinicalTrials.gov ID
- NCT00768144
- Acronym / sponsor ID
- 08-056
- Conditions
- Ovarian Cancer, Fallopian Tube Cancer, Peritoneal Cancer
- Keywords
- Sutent, sunitinib
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Dana-Farber Cancer InstituteUniversity, hospital or other
- Collaborators
- Beth Israel Deaconess Medical Center, Brigham and Women's Hospital, Massachusetts General Hospital
- Study start
- Sep 2008
- Primary completion
- May 2012 (actual)
- Study completion
- Feb 2013 (actual)
- First posted
- 7 Oct 2008 (estimated)
- Results
- Posted 2 Dec 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine the effectiveness of sunitinib on participants with ovarian, fallopian tube or peritoneal cancer. Sunitinib is a newly discovered drug that may stop cancer cells from growing by blocking the blood supply to the tumor.
Detailed description
This study used a two-stage design to evaluate efficacy of sunitinib based on overall response (OR) defined as complete response (CR) or partial response (PR). The null and alternative OR rate were 5% and 20%. If one or more patients enrolled in the stage one cohort (n=17 patients) achieved PR or better than accrual would proceed to stage two (n=18 patients). There was 42% probability of stopping the trial at stage one if the true OR rate was 5%. With 35 patients, this design had 85% power to detect the 15% difference in OR rates assuming 2-sided type I error rate of 0.05.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Sunitinib | Experimental | Drug: SunitinibPatients received oral Sunitinib at the daily dose of 37.5 mg continuously over a 28- day treatment cycle. Treatment continued until clinical or radiological evidence of progressive disease or excessive toxicity. |
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 or cytologically confirmed epithelial ovarian, fallopian tube or peritoneal cancer
- Recurrent or refractory disease
- Measurable disease, defined by RECIST
- 0 to 3 prior cytotoxic chemotherapy or biologic regimens for metastatic disease
- Adverse events related to prior tumor-specific therapy must have resolved to less than or equal to grade 1 prior to study entry
Key exclusion criteria (16 listed)
- Receiving systemic therapy less than 14 days prior to starting sunitinib
- Receiving any other investigational agent
- Received prior sunitinib
- Untreated brain metastases, spinal cord compression, or evidence of symptomatic brain metastases or leptomeningeal disease as noted on screening CT or MRI scans
- Any of the following within the 6 months prior to study drug administration: myocardial infarction, severe/unstable angina, coronary/peripheral artery bypass graft, symptomatic congestive heart failure, cerebrovascular accident or transient ischemic attack, or pulmonary embolism.
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 |
|---|---|---|
| SunitinibAlso: Sutent | Drug | Sunitinib |
Primary outcome
Overall Response Rate
Time frame: Clinical assessments were performed weekly for first 4 weeks and every 2 wks in subsequent cycles. Disease was evaluated radiologically at baseline, before each odd cycle and at end of trt.
Best response on treatment was based on RECIST 1.0 criteria with overall response defined as achieving partial response (PR) or complete response (CR). Per RECIST 1.0 for target lesions, CR is complete disappearance of all target lesions and PR is at least a 30% decrease in the sum of longest diameter (LD) of target lesions, taking as reference baseline sum LD. To be assigned a status of CR or PR, changes in tumor measurements must be confirmed by repeat assessments performed no fewer than 4 weeks after the response criteria are first met. PR or better overall response assumes at a minimum incomplete response/stable disease (SD) for the evaluation of non-target lesions and absence of new lesions.
2 secondary outcomes
16-Week Progression-Free Survival
Time frame: Clinical assessments were performed weekly for first 4 weeks and every 2 weeks in subsequent cycles. Disease was evaluated radiologically at baseline, before each odd cycle and at end of treatment.
Progression-Free Survival
Time frame: Clinical assessments were performed weekly for first 4 weeks and every 2 weeks in subsequent cycles. Disease was evaluated radiologically at baseline, before each odd cycle and at end of treatment.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Aug 2018.
- 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.
Susana M. Campos, MD principal investigator
Dana-Farber Cancer Institute
3 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 in people with Ovarian Cancer and Fallopian Tube Cancer, run by Dana-Farber Cancer Institute at 3 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 16 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 24 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 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 2 Dec 2014). 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: Clinical assessments were performed weekly for first 4 weeks and every 2 wks in subsequent cycles. Disease was evaluated radiologically at baseline, before each odd cycle and at end of trt.). 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 24 Aug 2018.