Ovarian CancerPhase 2NCT00928642
Gleevec and Gemzar in Patients With Epithelial Ovarian Cancer
A Phase 2 study testing imatinib mesylate by mouth and Gemcitabine Intravenous in people with Ovarian Cancer and Primary Peritoneal Cancer, run by Henry M. Jackson Foundation for the Advancement of Military Medicine at 1 site in United States.
Trial summary
This study will evaluate the efficacy and tolerability of the combination of Gleevec and Gemzar in patients with ovarian cancer, who have progressed after receiving at least one prior chemotherapy treatment. Gleevec is an oral chemotherapy drug used is this study and Gemzar is an IV chemotherapy drug used. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Ovarian Cancer, Primary Peritoneal Cancer
- What is being tested?
- imatinib mesylate by mouth and Gemcitabine Intravenous
- 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
- Jun 2009to Nov 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
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients 18 years of age or greater
- Histologically documented diagnosis of ovarian cancer or primary peritoneal cancer. Histological subtypes include: mucinous tumor, serous tumor, endometrioid tumor, and other histologies including clear cell and undifferentiated epithelial tumors.
- At least one measurable site of disease (as defined by Southwestern Oncology Group Solid Tumor Response Criteria) or other response assessment criteria, as appropriate.
- Patients must have relapsed after receiving at least one prior platinum-based chemotherapy.
- Performance status of 0, 1, 2, (ECOG)
- Adequate end organ function: Total bilirubin < 1.5 x ULN, SGOT and SGPT < 2.5 UNL, creatinine < 1.5 x UNL, ANC > 1.5 x 109/L, platelets > 100 x 109/L.
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- Patients will most likely have had their ovaries removed at the time off initial surgery. If any subjects are of childbearing potential at the time of entry, they must have negative pregnancy test within 7 days before initiation of study drug dosing. Postmenopausal women must be amenorrheic for at least 12 months to be considered of non-childbearing potential. Subjects of reproductive potential must agree to employ and effective barrier method of birth control throughout the study and for up to 3 months following discontinuation of the study drug.
- Written, voluntary informed consent.
- Patients must be eligible for care at a military medical treatment facility.
Who cannot join
- Patient has received prior treatment with Gemzar.
- Patient has received any other investigational agents within 28 days of the first day of study drug dosing.
- Patient is < 5 years free of another primary malignancy except: if the other primary malignancy is neither currently clinically significant nor requiring active intervention, or if other primary malignancy is a basal cell skin cancer or a cervical carcinoma in situ. Existence of any other malignant disease is not allowed.
- Patient with Grade III/IV cardiac problems as defined but the New York Heart Association Criteria.
- Patients who are pregnant or breast-feeding.
- Patient has a severe and/or uncontrolled medical disease (i,e. uncontrolled diabetes, uncontrolled chronic renal disease, or active uncontrolled infection).
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- Patient has a known untreated or progressive brain metastasis.
- Patient has known chronic liver diseases (i.e. chronic active hepatitis, and cirrhosis.
- Patient has a known diagnosis of human immunodeficiency virus (HIV infection ).
- Patient received chemotherapy within 4 weeks (6 weeks for nitrosourea or mitomycin-C) prior to study entry, unless the disease is rapidly progressing..
- Patient previously received radiotherapy to greater than or equal to 25% of the bone marrow.
- Patient had a major surgery within 2 weeks prior to study entry.
- Patient with any significant history of non-compliance to medical regimens or with inability to grant reliable informed consent.
Trial locations and contacts
1 site in 1 country.
United States1 site
Madigan Army Medical Center
Tacoma, Washington, 98431
About this study
Official title: A Phase II Trial of Gleevec and Gemzar in Patients With Epithelial Ovarian Cancer Who Have Failed at Least Two Prior Therapies
This study will evaluate the efficacy and tolerability of the combination of Gleevec and Gemzar in patients with ovarian cancer, who have progressed after receiving at least one prior chemotherapy treatment. Gleevec is an oral chemotherapy drug used is this study and Gemzar is an IV chemotherapy drug used. Participation in the treatment portion of the study will continue as long as the patient's tumors shrink or remain stable and as long as the patient is able to tolerate the study drug. The follow-up portion of the study will last for 5 years.
Read the detailed description
Each 21 day period will be considered a cycle. Disease status will be assessed with a Cancer Antigen (CA)-125 prior to the start of each new cycle with an assessment of measurable diseased by either CT or MRI every 6 weeks. Treatment will continue until disease progression, unacceptable toxicities, or the patient elects to withdraw from the study. All patients will be followed until disease progression or study withdraw. In addition, following disease progression, patients will be monitored for delayed toxicity and survival for a period of 5 years, unless consent is withdrawn.
- Conditions
- Ovarian Cancer, Primary Peritoneal Cancer
- Being tested
- imatinib mesylate by mouth, Gemcitabine Intravenous
- Keywords
- ovarian, cancer, peritoneal, endometrioid, mucinous, serous, clear cell
- Medical subject headings
- Ovarian Neoplasms, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
imatinib mesylate by mouthDrug
Also called Gleevec
imatinib mesylate - 400mg orally, daily on Days 1-5 and 8-12 of a 21 day cycle.
Gemcitabine IntravenousDrug
Also called Gemzar
Gemcitabine - 1000 mg/m2 IV on Day 3 and Day 10 of a 21 day cycle
| Study group | Role | What they receive |
|---|---|---|
| Oral Imatinib plus intravenous gemcitabine | Experimental | All research subjects receive oral imatinib 400mg days 1-5 and 8-12 of a 21 day cycle.
All research subjects received IV gemcitabine 1000mg/m2 days 3 and 10 of a 21-day cycle. .
All subjects had epithelial ovarian cancer or primary peritoneal carcinomatosis and had failed to respond to prior chemotherapy or progressed after prior chemotherapy. Receives: Drug: imatinib mesylate by mouth; Drug: Gemcitabine Intravenous |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Cystostatic, Anti-tumor Activity of the Combination of Gleevec and Gemzar Via Progression-free Survival for at Least Six Months in Patients With Recurrent or Persistent Epithelial Ovarian or Primary Peritoneal Carcinoma.
Progression free survival at six months was assessed for all research subjects. Progression defined by SWOG criteria: Invest New Drugs. 1992 Nov;10(4):239-53. Progression is defined as > 50% increase in the sume of measured cross sectional area of areasa of measurable disease, measured from the lowest measured amount of disease. Progression is also defined as new areas of measurabe disease.
Measured: Time to progression was measured from enrollment in study until documented disease progression over a period not greater than 2 years.
To Determine the Safety and Tolerability Via Frequency and Severity of Adverse Effect of Combination Gleevec and Gemzar in This Cohort of Patients as Assessed Byt Common Toxicity Criteria
Toxicity was assess prior to each cycle of therapy (every 3 weeks) and graded based on NCI common toxicity criteria
Measured: Until disease progression or unacceptable toxicity
Secondary outcomes (4)
Tumor Response Rates Using Modified SWOG Criteria to the Combination of Gleevec and Gemzar in Patients With Relapsed Ovarian Cancer Who Have Failed at Least One Prior Chemotherapy Treatment.
Best response to thearpy was assessed using modified SWOG criteria (same as for outcome masure #1). Subjects were assess as "complete response", "partial response", "stable disease", and "progressive disease" after 2 cycles (6 weeks) of beginning treatment and every 6 weeks afterward until progression of disease, unacceptable toxicity, or subject withdrawl from study.
the measurement reported is the number of patients who met the criteria for partial response.
Measured: Subjects treated until progression of disease or unacceptable toxicity. no maximum dose was specified
To Determine the Distribution of the Overall Survival
All subjects were followed after treatment was complete to assess overall survival.
Measured: Until death
To Estimate the Clinical Response Rate(Partial and Complete Response as Defined Under the SWOG Criterial)
Using SWOG criteria for response of measurable disease, subject best response was assessed. First assessment was 6 weeks after starting treatment. Subjequent evaluations were every 6 weeks in patients who remained on study.
Repsonse rate was the sum of Complete Repsonse and Partial Response.
Measured: until disease progression or unacceptable toxicity
To Assess the Effects of Prognostic Variables; Initial Performance Status; Platinum Sensitivity, and Mucinous (or Clear Cell)Histology on Progression-free Survival Overall.
The study was stopped after 8 subjects. It was not possible to perform meaningful analysis on prognostic variables. this outcome measure was not done.
Measured: Until disease progression
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2009 (estimated)
- Study startJun 2009
- Primary completionNov 2010
- Study completionNov 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.
- Other trials for Ovarian 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Henry M. Jackson Foundation for the Advancement of Military Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- Novartis
- Responsible party
- Principal investigator, david mccune, md, Madigan Army Medical Center
- Investigators
- David McCune, MD, MPH, Principal investigator, Madigan Army Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00928642
- Sponsor's protocol ID
- CSTI571BUS241
- Other IDs
- MAMC#206126
- Status last verified
- Oct 2014
- First submitted
- 25 Jun 2009
- Last updated
- 21 Oct 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Trial of Gleevec and Gemzar in Patients With Epithelial Ovarian Cancer Who Have Failed at Least Two Prior Therapies
- ClinicalTrials.gov ID
- NCT00928642
- Acronym / sponsor ID
- CSTI571BUS241
- Conditions
- Ovarian Cancer, Primary Peritoneal Cancer
- Keywords
- ovarian, cancer, peritoneal, endometrioid, mucinous, serous, clear cell
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Henry M. Jackson Foundation for the Advancement of Military MedicineUniversity, hospital or other
- Collaborators
- Novartis
- Study start
- Jun 2009
- Primary completion
- Nov 2010 (actual)
- Study completion
- Nov 2010 (actual)
- First posted
- 26 Jun 2009 (estimated)
- Results
- Posted 21 Oct 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will evaluate the efficacy and tolerability of the combination of Gleevec and Gemzar in patients with ovarian cancer, who have progressed after receiving at least one prior chemotherapy treatment. Gleevec is an oral chemotherapy drug used is this study and Gemzar is an IV chemotherapy drug used. Participation in the treatment portion of the study will continue as long as the patient's tumors shrink or remain stable and as long as the patient is able to tolerate the study drug. The follow-up portion of the study will last for 5 years.
Detailed description
Each 21 day period will be considered a cycle. Disease status will be assessed with a Cancer Antigen (CA)-125 prior to the start of each new cycle with an assessment of measurable diseased by either CT or MRI every 6 weeks. Treatment will continue until disease progression, unacceptable toxicities, or the patient elects to withdraw from the study. All patients will be followed until disease progression or study withdraw. In addition, following disease progression, patients will be monitored for delayed toxicity and survival for a period of 5 years, unless consent is withdrawn.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Oral Imatinib plus intravenous gemcitabine | Experimental | Drug: imatinib mesylate by mouth, Drug: Gemcitabine IntravenousAll research subjects receive oral imatinib 400mg days 1-5 and 8-12 of a 21 day cycle. All research subjects received IV gemcitabine 1000mg/m2 days 3 and 10 of a 21-day cycle. . All subjects had epithelial ovarian cancer or primary peritoneal carcinomatosis and had failed to respond to prior chemotherapy or progressed after prior chemotherapy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Patients 18 years of age or greater
- Histologically documented diagnosis of ovarian cancer or primary peritoneal cancer. Histological subtypes include: mucinous tumor, serous tumor, endometrioid tumor, and other histologies including clear cell and undifferentiated epithelial tumors.
- At least one measurable site of disease (as defined by Southwestern Oncology Group Solid Tumor Response Criteria) or other response assessment criteria, as appropriate.
- Patients must have relapsed after receiving at least one prior platinum-based chemotherapy.
- Performance status of 0, 1, 2, (ECOG)
Key exclusion criteria (13 listed)
- Patient has received prior treatment with Gemzar.
- Patient has received any other investigational agents within 28 days of the first day of study drug dosing.
- Patient is < 5 years free of another primary malignancy except: if the other primary malignancy is neither currently clinically significant nor requiring active intervention, or if other primary malignancy is a basal cell skin cancer or a cervical carcinoma in situ. Existence of any other malignant disease is not allowed.
- Patient with Grade III/IV cardiac problems as defined but the New York Heart Association Criteria.
- Patients who are pregnant or breast-feeding.
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 |
|---|---|---|
| imatinib mesylate by mouthAlso: Gleevecimatinib mesylate - 400mg orally, daily on Days 1-5 and 8-12 of a 21 day cycle. | Drug | Oral Imatinib plus intravenous gemcitabine |
| Gemcitabine IntravenousAlso: GemzarGemcitabine - 1000 mg/m2 IV on Day 3 and Day 10 of a 21 day cycle | Drug | Oral Imatinib plus intravenous gemcitabine |
Primary outcome
The Cystostatic, Anti-tumor Activity of the Combination of Gleevec and Gemzar Via Progression-free Survival for at Least Six Months in Patients With Recurrent or Persistent Epithelial Ovarian or Primary Peritoneal Carcinoma.
Time frame: Time to progression was measured from enrollment in study until documented disease progression over a period not greater than 2 years.
Progression free survival at six months was assessed for all research subjects. Progression defined by SWOG criteria: Invest New Drugs. 1992 Nov;10(4):239-53. Progression is defined as > 50% increase in the sume of measured cross sectional area of areasa of measurable disease, measured from the lowest measured amount of disease. Progression is also defined as new areas of measurabe disease.
To Determine the Safety and Tolerability Via Frequency and Severity of Adverse Effect of Combination Gleevec and Gemzar in This Cohort of Patients as Assessed Byt Common Toxicity Criteria
Time frame: Until disease progression or unacceptable toxicity
Toxicity was assess prior to each cycle of therapy (every 3 weeks) and graded based on NCI common toxicity criteria
4 secondary outcomes
Tumor Response Rates Using Modified SWOG Criteria to the Combination of Gleevec and Gemzar in Patients With Relapsed Ovarian Cancer Who Have Failed at Least One Prior Chemotherapy Treatment.
Time frame: Subjects treated until progression of disease or unacceptable toxicity. no maximum dose was specified
To Determine the Distribution of the Overall Survival
Time frame: Until death
To Estimate the Clinical Response Rate(Partial and Complete Response as Defined Under the SWOG Criterial)
Time frame: until disease progression or unacceptable toxicity
To Assess the Effects of Prognostic Variables; Initial Performance Status; Platinum Sensitivity, and Mucinous (or Clear Cell)Histology on Progression-free Survival Overall.
Time frame: Until disease progression
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Oct 2014.
- 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.
David McCune, MD, MPH principal investigator
Madigan Army Medical Center
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 imatinib mesylate by mouth and Gemcitabine Intravenous in people with Ovarian Cancer and Primary Peritoneal Cancer, run by Henry M. Jackson Foundation for the Advancement of Military Medicine 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 9 inclusion and 13 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 21 Oct 2014. 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 21 Oct 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?
The Cystostatic, Anti-tumor Activity of the Combination of Gleevec and Gemzar Via Progression-free Survival for at Least Six Months in Patients With Recurrent or Persistent Epithelial Ovarian or Primary Peritoneal Carcinoma. (time frame: Time to progression was measured from enrollment in study until documented disease progression over a period not greater than 2 years.). The study lists 2 primary outcomes in all. 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 21 Oct 2014.