Ovarian CancerPhase 2NCT00418093
Oxaliplatin, Gemcitabine and Bevacizumab in Women With Recurrent Mullerian Carcinoma
A Phase 2 study testing Gemcitabine, Oxaliplatin and Bevacizumab in people with Ovarian Cancer and Fallopian Tube Cancer, run by Dana-Farber Cancer Institute at 2 sites in United States.
Trial summary
The main purpose of this study is to begin to collect information and try to learn whether or not the combination of oxaliplatin, gemcitabine and bevacizumab works in treating women with recurrent mullerian carcinoma. We will also collect more information about the safety and side effects of this combination of drugs. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Ovarian Cancer, Fallopian Tube Cancer, Primary Peritoneal Cancer
- What is being tested?
- Gemcitabine, Oxaliplatin and Bevacizumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 19 participants
- Where
- 2 sitesUnited States
- Study dates
- Sep 2006to Oct 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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Recurrent ovarian, fallopian tube, or primary peritoneal carcinoma. Histologic or cytologic confirmation of the original primary tumor is required.
- Must have measurable disease which is defined as at least one lesion that can be accurately measured in at least one dimension. Each lesion must be >20mm when measured by conventional techniques.
- Must have at least one "target lesion" to be used to assess response.
- Platinum-sensitive tumors, defined as a platinum free interval of at least 6 months, and may have had up to two prior treatment regimens.
- Eastern Cooperative Oncology Group score of 0 or 1
- Life expectancy of 12 weeks or longer
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- 18 years of age or older
- Adequate bone marrow, renal, neurologic and liver function
- Normal blood coagulation parameters
Who cannot join
- Chemotherapy within last 3 weeks
- Current, recent (within 4 weeks), or planned participation in an experimental drug study other than a Genentech-sponsored bevacizumab cancer study.
- Known bleeding disorder or coagulopathy, or history of stroke.
- Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to study entry or the anticipation of need for major surgical procedure during the course of the study.
- Minor surgical procedures within 14 days of study entry.
- Significant cardiovascular disease, New York Heart Association Grade II or greater congestive heart failure, serious cardiac arrhythmia requiring medication, a history of deep vein thrombosis, or Grade II or greater, clinically significant peripheral vascular disease within 1 year of study entry.
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- Urine protein:creatinine ration greater than or equal to 1.0
- History or clinical evidence of central nervous system disease
- Patients with other invasive malignancies, with the exception of non-melanoma skin cancer, who have evidence of disease within last three years.
- More than 2 prior lines of chemotherapy
- Previous treatment with a VEGF targeted inhibitor or antibody
- Serious non-healing wound, ulcer or bone fracture
- Prior radiation therapy to more than one-third of hematopoietic sites.
- History of abdominal fistulas, gastrointestinal perforation, intra-abdominal abscess, or partial bowel obstruction within 6 months
- Pregnant or lactating
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Massachusetts General Hospital
Boston, Massachusetts, 02114
Dana-Farber Cancer Institute
Boston, Massachusetts, 02215
About this study
Official title: A Phase II Evaluation of Oxaliplatin, Gemcitabine and Bevacizumab in Women With Recurrent Mullerian Carcinoma
The main purpose of this study is to begin to collect information and try to learn whether or not the combination of oxaliplatin, gemcitabine and bevacizumab works in treating women with recurrent mullerian carcinoma. We will also collect more information about the safety and side effects of this combination of drugs. Gemcitabine and oxaliplatin are chemotherapy drugs that kill cancer cells. Bevacizumab is a new anti-cancer drug that works to slow or stop cell growth in cancerous tumors by decreasing the blood supply to the tumors.
Read the detailed description
- The study treatment is divided into periods called cycles. Each cycle is 28 days long. Participants will be given the study drugs intravenously on day 1 and day 15 of each cycle.
- Gemcitabine will be given first, over a period of 30 minutes. Then oxaliplatin over a period of 2 hours. Finally, bevacizumab will be given over a period of 30 to 90 minutes. Participants will continue study treatment as long as their tumor is not growing and they are not experiencing unacceptable side effects. If the tumor goes away completely, the participant will have 2 more cycle of study treatment.
- Blood will be drawn for routine testing every week during study treatment to check for side effects. Before day 1 and 15 of each cycle the following tests and procedures will be performed: a medical history; complete physical exam; vital signs; blood tests; and urine tests. Before day 1 of every other cycle, the following additional procedures will be performed: A CT scan, x-ray or ultrasound of your abdomen and pelvis; an x-ray of the chest (if required by the study doctor); blood tests; and urine samples.
- If the participant's tumor goes away, they will be asked to return to the clinic for follow-up visits every 3 months for 2 years, then every 6 months for 3 years. At each follow-up visit the following tests and procedures will be performed: medical history; complete physical examination; CT scan, x-ray or ultrasound of the abdomen and pelvis; x-ray of the chest; and other tests if the doctor feels they are needed.
- There is an optional sub-study that six subjects will be asked to take a part in that will give the study doctors important information about the way the body uses and breaks down the study drugs. This sub-study will involve special surgical procedures and scans that will be done during cycle 1 of the study treatment.
- Being tested
- Gemcitabine, Oxaliplatin, Bevacizumab
- Keywords
- mullerian carcinoma
- 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.
GemcitabineDrug
Given intravenously over 30 minutes on day 1 and day 15 of a 28-day cycle. Participants can continue study treatment as long as there is no disease progression.
OxaliplatinDrug
Given intravenously over 2 hours on day 1 and day 15 of a 28-day cycle. Participants can continue study treatment as long as there is no disease progression.
BevacizumabDrug
Given intravenously over 30-90 minutes on day 1 and day 15 of a 28-day cycle. Participants can continue study treatment as long as there is no disease progression.
| Study group | Role | What they receive |
|---|---|---|
| Chemotherapy | Experimental | All patients received oxaliplatin, gemcitabine, and bevacizumab Receives: Drug: Gemcitabine; Drug: Oxaliplatin; Drug: Bevacizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Partial Response Rate
Precentage of women who responded to the treatment regimen Response was determined by RECIST criteria
Measured: Outcome was assessed every 2 cycles (every 8 weeks) for the duration on study, an average of 4.5 cycles (18 weeks)
Secondary outcomes (3)
Progression Free Survival
Time participant remains free of progression of her disease. Evaluated by RECIST criteria
Measured: Assessed every 2 cycles (every 8 weeks) of chemotherapy until progression of disease is documented with a median duration of follow up of 24 months
Overall Survival
Duration of time participants are alive after enrolling on the study. Assessed by clinical records
Measured: Assessed every 3 months until death from disease, other causes, or loss to follow up at a median follow up of 24 months
Determine the Nature and Degree of Toxicities Following Treatment With Oxaliplatin, Gemcitabine, and Bevacizumab in This Patient Population.
The nature and toxicities of treatment were graded per the National Cancer Institute Common Terminology Criteria of Adverse Events version 3.0 Patients with grade 2 or higher toxicity were reported
Measured: Toxicities were assessed every cycle and for up to 30 days after being removed from the trial
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jan 2007 (estimated)
- Study startSep 2006
- Primary completionJan 2011
- Study completionOct 2011
Why it stopped: THe study was terminated early due to a lack of accural
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
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dana-Farber Cancer Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Massachusetts General Hospital, Brigham and Women's Hospital, Eli Lilly and Company, Sanofi-Synthelabo, Genentech, Inc.
- Responsible party
- Principal investigator, Neil S. Horowitz, MD, Dana-Farber Cancer Institute
- Investigators
- Neil Horowitz, MD, Principal investigator, Dana-Farber Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00418093
- Sponsor's protocol ID
- 04-356
- Status last verified
- Jun 2014
- First submitted
- 2 Jan 2007
- Last updated
- 19 Jun 2014
- Results posted
- Yes, on ClinicalTrials.gov
Study at a glance
From the registry record, last updated by the sponsor on 19 Jun 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Evaluation of Oxaliplatin, Gemcitabine and Bevacizumab in Women With Recurrent Mullerian Carcinoma
- ClinicalTrials.gov ID
- NCT00418093
- Acronym / sponsor ID
- 04-356
- Keywords
- mullerian carcinoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: THe study was terminated early due to a lack of accural
- Enrolment
- 19 participants (actual)
- Lead sponsor
- Dana-Farber Cancer InstituteUniversity, hospital or other
- Collaborators
- Massachusetts General Hospital, Brigham and Women's Hospital, Eli Lilly and Company, Sanofi-Synthelabo, Genentech, Inc.
- Study start
- Sep 2006
- Primary completion
- Jan 2011 (actual)
- Study completion
- Oct 2011 (actual)
- First posted
- 4 Jan 2007 (estimated)
- Results
- Posted 19 Jun 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The main purpose of this study is to begin to collect information and try to learn whether or not the combination of oxaliplatin, gemcitabine and bevacizumab works in treating women with recurrent mullerian carcinoma. We will also collect more information about the safety and side effects of this combination of drugs. Gemcitabine and oxaliplatin are chemotherapy drugs that kill cancer cells. Bevacizumab is a new anti-cancer drug that works to slow or stop cell growth in cancerous tumors by decreasing the blood supply to the tumors.
Detailed description
- The study treatment is divided into periods called cycles. Each cycle is 28 days long. Participants will be given the study drugs intravenously on day 1 and day 15 of each cycle.
- Gemcitabine will be given first, over a period of 30 minutes. Then oxaliplatin over a period of 2 hours. Finally, bevacizumab will be given over a period of 30 to 90 minutes. Participants will continue study treatment as long as their tumor is not growing and they are not experiencing unacceptable side effects. If the tumor goes away completely, the participant will have 2 more cycle of study treatment.
- Blood will be drawn for routine testing every week during study treatment to check for side effects. Before day 1 and 15 of each cycle the following tests and procedures will be performed: a medical history; complete physical exam; vital signs; blood tests; and urine tests. Before day 1 of every other cycle, the following additional procedures will be performed: A CT scan, x-ray or ultrasound of your abdomen and pelvis; an x-ray of the chest (if required by the study doctor); blood tests; and urine samples.
- If the participant's tumor goes away, they will be asked to return to the clinic for follow-up visits every 3 months for 2 years, then every 6 months for 3 years. At each follow-up visit the following tests and procedures will be performed: medical history; complete physical examination; CT scan, x-ray or ultrasound of the abdomen and pelvis; x-ray of the chest; and other tests if the doctor feels they are needed.
- There is an optional sub-study that six subjects will be asked to take a part in that will give the study doctors important information about the way the body uses and breaks down the study drugs. This sub-study will involve special surgical procedures and scans that will be done during cycle 1 of the study treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Chemotherapy | Experimental | Drug: Gemcitabine, Drug: Oxaliplatin, Drug: BevacizumabAll patients received oxaliplatin, gemcitabine, and bevacizumab |
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)
- Recurrent ovarian, fallopian tube, or primary peritoneal carcinoma. Histologic or cytologic confirmation of the original primary tumor is required.
- Must have measurable disease which is defined as at least one lesion that can be accurately measured in at least one dimension. Each lesion must be >20mm when measured by conventional techniques.
- Must have at least one "target lesion" to be used to assess response.
- Platinum-sensitive tumors, defined as a platinum free interval of at least 6 months, and may have had up to two prior treatment regimens.
- Eastern Cooperative Oncology Group score of 0 or 1
Key exclusion criteria (15 listed)
- Chemotherapy within last 3 weeks
- Current, recent (within 4 weeks), or planned participation in an experimental drug study other than a Genentech-sponsored bevacizumab cancer study.
- Known bleeding disorder or coagulopathy, or history of stroke.
- Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to study entry or the anticipation of need for major surgical procedure during the course of the study.
- Minor surgical procedures within 14 days of study entry.
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 |
|---|---|---|
| GemcitabineGiven intravenously over 30 minutes on day 1 and day 15 of a 28-day cycle. Participants can continue study treatment as long as there is no disease progression. | Drug | Chemotherapy |
| OxaliplatinGiven intravenously over 2 hours on day 1 and day 15 of a 28-day cycle. Participants can continue study treatment as long as there is no disease progression. | Drug | Chemotherapy |
| BevacizumabGiven intravenously over 30-90 minutes on day 1 and day 15 of a 28-day cycle. Participants can continue study treatment as long as there is no disease progression. | Drug | Chemotherapy |
Primary outcome
Partial Response Rate
Time frame: Outcome was assessed every 2 cycles (every 8 weeks) for the duration on study, an average of 4.5 cycles (18 weeks)
Precentage of women who responded to the treatment regimen Response was determined by RECIST criteria
3 secondary outcomes
Progression Free Survival
Time frame: Assessed every 2 cycles (every 8 weeks) of chemotherapy until progression of disease is documented with a median duration of follow up of 24 months
Overall Survival
Time frame: Assessed every 3 months until death from disease, other causes, or loss to follow up at a median follow up of 24 months
Determine the Nature and Degree of Toxicities Following Treatment With Oxaliplatin, Gemcitabine, and Bevacizumab in This Patient Population.
Time frame: Toxicities were assessed every cycle and for up to 30 days after being removed from the trial
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jun 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.
Neil Horowitz, MD principal investigator
Dana-Farber Cancer Institute
2 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 Gemcitabine, Oxaliplatin and Bevacizumab in people with Ovarian Cancer and Fallopian Tube Cancer, run by Dana-Farber Cancer Institute at 2 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 15 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 19 Jun 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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 19 Jun 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?
Partial Response Rate (time frame: Outcome was assessed every 2 cycles (every 8 weeks) for the duration on study, an average of 4.5 cycles (18 weeks)). 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 19 Jun 2014.