Ovarian CancerPhase 2NCT00588237
Intravenous and Intraperitoneal Paclitaxel, Intraperitoneal Cisplatin, and Intravenous Bevacizumab for the Initial Treatment of Optimal Stage II or III Ovarian, Primary Peritoneal, and Fallopian Tube Cancer
A Phase 2 study testing Paclitaxel,Cisplatin, Bevacizumab in people with Ovarian Cancer and Primary PERITONEUM, run by Memorial Sloan Kettering Cancer Center at 1 site in United States.
Trial summary
The purpose of this study is to test whether it is safe to treat your cancer with 3 drugs instead of 2 drugs. After surgery, your cancer is typically treated with 2 drugs called cisplatin and paclitaxel (also known as Taxol). Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Ovarian Cancer, Primary PERITONEUM, Fallopian Tube Cancer
- What is being tested?
- Paclitaxel,Cisplatin, Bevacizumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2006to Nov 2014
- 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
- Subjects must have signed an approved informed consent.
- Subjects with histologic diagnosis of epithelial ovarian carcinoma, primary peritoneal carcinoma, or fallopian tube carcinoma, Stage II or III, with optimal (≤ or equal to 1 cm residual disease) residual disease following initial surgery. All subjects must have had appropriate surgery for ovarian, primary peritoneal, or fallopian tube carcinoma with appropriate tissue available for histologic evaluation to confirm diagnosis and stage. Pathology must be verified at Memorial Sloan-Kettering Cancer Center.
- Subjects with the following histologic epithelial cell types are eligible: Serous adenocarcinoma, endometrioid adenocarcinoma, mucinous adenocarcinoma, undifferentiated carcinoma, clear cell adenocarcinoma, mixed epithelial carcinoma, transitional cell carcinoma, malignant Brenner's Tumor, or adenocarcinoma N.O.S.
- Subjects must have a Karnofsky Performance Status (KPS) of ≥ or equal to 70%.
- Subjects must be entered no more than 12 weeks postoperatively.
- Bone marrow function:
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- Absolute neutrophil count (ANC) ≥ than or equal to 1,500/µl (equivalent to Common Toxicity Criteria (CTC) Grade 1)
- Platelets ≥ than or equal to 100,000/µl (CTC Grade 0-1)
- Renal function: Creatinine ≤ than or equal to 1.5 mg/dl
- Hepatic function: Bilirubin ≤ than or equal to 1.5 x ULN (CTC Grade 1) AST ≤ than or equal to 2.5 x ULN (CTC Grade 1)
- Neurologic function:Neuropathy (sensory) ≤ than CTC Grade 1
- Urine Protein Creatinine: Urine protein creatinine (UPC) ratio must be < than 1.0 gm. If UPC ratio > than or equal to 1, collection of 24-hour urine measurement of urine protein is recommended as part of the patient's medical management off-study. *
- UPC ratio of spot urine is an estimation of the 24 urine protein excretion - a UPC ratio of 1 is roughly equivalent to a 24-hour urine protein of 1 gm. UPC ratio is calculated using one of the following formulas:
- [urine protein]/[urine creatinine] - if both protein and creatinine are reported in mg/dL
- [(urine protein) x0.088]/[urine creatinine] - if urine creatinine is reported in mmol/L
- The UPCR has been found to correlate directly with the amount of protein excreted in a 24 hour urine collection. Specifically, a UPCR of 1.0 is equivalent to 1.0 gram of protein in a 24 hour urine collection. Obtain at least 4 ml of a random urine sample in a sterile container (does not have to be a 24 hour urine). Send sample to lab with request for urine protein and creatinine levels [separate requests]. The lab will measure protein concentration (mg/dL) and creatinine concentration (mg/dL). The UPCR is derived as follows: protein concentration (mg/dL)/creatinine (mg/dL). Patients must have a UPCR < 1.0 to allow participation in the study.
- Blood coagulation parameters:
- PT such that international normalized ratio (INR) is < than or equal to 1.5 (or an in-range INR, usually between 2 and 3, if a patient is on a stable dose of therapeutic warfarin) and a PTT < 1.2 times the upper limit of normal.
- Patients of childbearing potential must have a negative serum pregnancy test prior to study entry and be practicing an effective form of contraception during the study and for at least 6 months after receiving the final treatment of bevacizumab.
- Patients must have an Intraperitoneal (IP) port in place. If a patient does not have an IP port, she must be willing to undergo surgical placement of one.
Who cannot join
- Subjects with a current diagnosis of epithelial ovarian tumor of low malignant potential (borderline carcinomas) are not eligible. Subjects with a prior diagnosis of a low malignant potential tumor that was surgically resected and who subsequently develop invasive adenocarcinoma are eligible, provided that they have not received prior chemotherapy for any ovarian tumor.
- Subjects who have received prior radiotherapy to any portion of the abdominal cavity or pelvis are excluded. Prior radiation for localized cancer of the breast, head and neck, or skin is permitted, provided that it was completed more than 3 years prior to enrollment, and the subject remains free of recurrent or metastatic disease.
- Subjects who have received prior chemotherapy for any abdominal or pelvic tumor are excluded. Subjects may have received prior adjuvant chemotherapy for localized breast cancer, provided that it was completed more than 3 years prior to enrollment, and that the subject remains free of recurrent or metastatic disease.
- Patients with synchronous primary endometrial cancer, or a history of primary endometrial cancer, are excluded unless all of the following conditions are met:
- Stage not greater than IB.
- Less than 3 mm invasion without vascular or lymphatic invasion
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- No poorly differentiated subtypes, including papillary serous, clear cell or other FIGO grade 3 lesions
- Patients with suboptimal (> 1 cm) residual disease, as determined by the operative surgeon.
- Patients who have received any targeted therapy (including but not limited to vaccines, antibodies, tyrosine kinase inhibitors) or hormonal therapy for management of their ovarian, peritoneal primary, or fallopian tube cancer.
- With the exception of non-melanoma skin cancer and other specific malignancies as noted above, subjects with other invasive malignancies who had (or have) any evidence of the other cancer present within the last 5 years or whose previous cancer treatment contraindicates this protocol therapy are excluded.
- Subjects with acute hepatitis.
- Subjects with active infection that requires parenteral antibiotics.
- Patients with serious, non-healing wound, ulcer, or bone fracture are not eligible. This includes history of abdominal fistula, gastrointestinal perforation or intra-abdominal abscess within 28 days. Patients with granulating incisions healing by secondary intention with no evidence of fascial dehiscence or infection are eligible but require weekly wound examinations.
- Patients with active bleeding or pathologic conditions that carry high risk of bleeding, such as known bleeding disorder, coagulopathy, or tumor involving major vessels.
- Patients with history or evidence upon physical examination of CNS disease, including primary brain tumor, seizures not controlled with standard medical therapy, any brain metastases, or history of cerebrovascular accident (CVA, stroke), transient ischemic attack (TIA) or subarachnoid hemorrhage within 6 months of the first date of treatment on this study.
- Patients with clinically significant cardiovascular disease. This includes:
- Uncontrolled hypertension, defined as systolic >150 mm Hg or diastolic > 90 mm Hg
- Myocardial infarction or unstable angina < 6 months prior to registration
- New York Heart Association (NYHA) Grade II or greater congestive heart failure
- Serious cardiac arrhythmia requiring medication
- CTCAE grade 2 or greater peripheral vascular disease
- Patients with major surgical procedure, open biopsy, laparoscopy (including intraperitoneal port placement) or significant traumatic injury within 28 days prior to the first date of bevacizumab therapy. Major surgical procedure anticipated during the course of the study. Minor surgical procedures, fine needle aspirates, or core biopsies within 7 days prior to the first date of bevacizumab therapy.
- Patients with known hypersensitivity to Chinese hamster ovary cell products or other recombinant human or humanized antibodies.
- Patients under the age of 18.
- Patients who are pregnant or nursing.
- Evidence of extensive intraperitoneal adhesions at the time of surgery, as determined by the operative surgeon.
Trial locations and contacts
1 site in 1 country.
United States1 site
Memorial Sloan-Kettering Cancer Center
New York, New York, 10065
About this study
Official title: A Phase II Study of Intravenous and Intraperitoneal Paclitaxel, Intraperitoneal Cisplatin, and Intravenous Bevacizumab for the Initial Treatment of Optimal Stage II or III Ovarian, Primary Peritoneal, and Fallopian Tube Cancer
The purpose of this study is to test whether it is safe to treat your cancer with 3 drugs instead of 2 drugs. After surgery, your cancer is typically treated with 2 drugs called cisplatin and paclitaxel (also known as Taxol). Cisplatin is given through a port in your belly, and Taxol is given both through the belly port and through the vein (IV). Large clinical studies have shown that this treatment gives the best results for women with your cancer. This treatment, however, also causes many side effects, especially belly pain, nerve injury, lowering of the immune system, and infection risk. In the study you are being asked to join, the dose of Cisplatin will be lower in order to try to lessen these problems. This study will also test the safety of adding a 3rd drug called bevacizumab (also known as Avastin). This drug has been shown to shrink ovarian, peritoneal, or fallopian tube cancer in some patients who have advanced disease, despite having received prior treatment for their cancer. Therefore, it may also be effective in patients, like you, who have a new diagnosis.
Unfortunately, Avastin can cause some dangerous side effects in women with advanced cancer. For instance, it can cause a hole in the intestines, and can increase the risk of blood clots and strokes. Avastin has not been given at the same time as IP therapy, so it is not known if this is a safe or effective combination. In this study, IV Avastin will be given in addition to IP cisplatin, IP Taxol, and IV Taxol, to patients like you who have not had any chemotherapy before. This study aims to find out what effects, good and/or bad, that this combination of drugs has on your body and on your type of cancer.
- Conditions
- Ovarian Cancer, Primary PERITONEUM, Fallopian Tube Cancer
- Being tested
- Paclitaxel,Cisplatin, Bevacizumab
- Keywords
- ovary, BEVACIZUMAB, CISPLATIN, TAXOL
- 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.
Paclitaxel,Cisplatin, BevacizumabDrug
IV paclitaxel, followed by IV Bevacizumab on Day 1. Bevacizumab treatment will begin cycle 2, day 1. IP cisplatin will be given on Day 2, and IP Paclitaxel on Day 8. Subjects will receive up to six cycles of therapy, or until disease progression or unacceptable toxicity.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Paclitaxel, Cisplatin, Bevacizumab Receives: Drug: Paclitaxel,Cisplatin, Bevacizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Objective Response
as determined by the GOG RECIST criteria
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2008 (estimated)
- Study startAug 2006
- Primary completionNov 2014
- Study completionNov 2014
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 Memorial Sloan Kettering Cancer CenterThe 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
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Memorial Sloan Kettering Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- Genentech, Inc.
- Responsible party
- Sponsor
- Investigators
- Jason Konner, MD, Principal investigator, Memorial Sloan Kettering Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00588237
- Sponsor's protocol ID
- 06-064
- Status last verified
- Dec 2015
- First submitted
- 22 Dec 2007
- Last updated
- 20 Jan 2016
- Results posted
- Yes, on ClinicalTrials.gov
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Study of Intravenous and Intraperitoneal Paclitaxel, Intraperitoneal Cisplatin, and Intravenous Bevacizumab for the Initial Treatment of Optimal Stage II or III Ovarian, Primary Peritoneal, and Fallopian Tube Cancer
- ClinicalTrials.gov ID
- NCT00588237
- Acronym / sponsor ID
- 06-064
- Conditions
- Ovarian Cancer, Primary PERITONEUM, Fallopian Tube Cancer
- Keywords
- ovary, BEVACIZUMAB, CISPLATIN, TAXOL
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Memorial Sloan Kettering Cancer CenterUniversity, hospital or other
- Collaborators
- Genentech, Inc.
- Study start
- Aug 2006
- Primary completion
- Nov 2014 (actual)
- Study completion
- Nov 2014 (actual)
- First posted
- 8 Jan 2008 (estimated)
- Results
- Posted 20 Jan 2016
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 test whether it is safe to treat your cancer with 3 drugs instead of 2 drugs. After surgery, your cancer is typically treated with 2 drugs called cisplatin and paclitaxel (also known as Taxol). Cisplatin is given through a port in your belly, and Taxol is given both through the belly port and through the vein (IV). Large clinical studies have shown that this treatment gives the best results for women with your cancer. This treatment, however, also causes many side effects, especially belly pain, nerve injury, lowering of the immune system, and infection risk. In the study you are being asked to join, the dose of Cisplatin will be lower in order to try to lessen these problems. This study will also test the safety of adding a 3rd drug called bevacizumab (also known as Avastin). This drug has been shown to shrink ovarian, peritoneal, or fallopian tube cancer in some patients who have advanced disease, despite having received prior treatment for their cancer. Therefore, it may also be effective in patients, like you, who have a new diagnosis.
Unfortunately, Avastin can cause some dangerous side effects in women with advanced cancer. For instance, it can cause a hole in the intestines, and can increase the risk of blood clots and strokes. Avastin has not been given at the same time as IP therapy, so it is not known if this is a safe or effective combination. In this study, IV Avastin will be given in addition to IP cisplatin, IP Taxol, and IV Taxol, to patients like you who have not had any chemotherapy before. This study aims to find out what effects, good and/or bad, that this combination of drugs has on your body and on your type of cancer.
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: Paclitaxel,Cisplatin, BevacizumabPaclitaxel, Cisplatin, Bevacizumab |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (20 listed)
- Subjects must have signed an approved informed consent.
- Subjects with histologic diagnosis of epithelial ovarian carcinoma, primary peritoneal carcinoma, or fallopian tube carcinoma, Stage II or III, with optimal (≤ or equal to 1 cm residual disease) residual disease following initial surgery. All subjects must have had appropriate surgery for ovarian, primary peritoneal, or fallopian tube carcinoma with appropriate tissue available for histologic evaluation to confirm diagnosis and stage. Pathology must be verified at Memorial Sloan-Kettering Cancer Center.
- Subjects with the following histologic epithelial cell types are eligible: Serous adenocarcinoma, endometrioid adenocarcinoma, mucinous adenocarcinoma, undifferentiated carcinoma, clear cell adenocarcinoma, mixed epithelial carcinoma, transitional cell carcinoma, malignant Brenner's Tumor, or adenocarcinoma N.O.S.
- Subjects must have a Karnofsky Performance Status (KPS) of ≥ or equal to 70%.
- Subjects must be entered no more than 12 weeks postoperatively.
Key exclusion criteria (26 listed)
- Subjects with a current diagnosis of epithelial ovarian tumor of low malignant potential (borderline carcinomas) are not eligible. Subjects with a prior diagnosis of a low malignant potential tumor that was surgically resected and who subsequently develop invasive adenocarcinoma are eligible, provided that they have not received prior chemotherapy for any ovarian tumor.
- Subjects who have received prior radiotherapy to any portion of the abdominal cavity or pelvis are excluded. Prior radiation for localized cancer of the breast, head and neck, or skin is permitted, provided that it was completed more than 3 years prior to enrollment, and the subject remains free of recurrent or metastatic disease.
- Subjects who have received prior chemotherapy for any abdominal or pelvic tumor are excluded. Subjects may have received prior adjuvant chemotherapy for localized breast cancer, provided that it was completed more than 3 years prior to enrollment, and that the subject remains free of recurrent or metastatic disease.
- Patients with synchronous primary endometrial cancer, or a history of primary endometrial cancer, are excluded unless all of the following conditions are met:
- Patients with suboptimal (> 1 cm) residual disease, as determined by the operative surgeon.
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 |
|---|---|---|
| Paclitaxel,Cisplatin, BevacizumabIV paclitaxel, followed by IV Bevacizumab on Day 1. Bevacizumab treatment will begin cycle 2, day 1. IP cisplatin will be given on Day 2, and IP Paclitaxel on Day 8. Subjects will receive up to six cycles of therapy, or until disease progression or unacceptable toxicity. | Drug | 1 |
Primary outcome
Overall Objective Response
Time frame: 2 years
as determined by the GOG RECIST criteria
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jan 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Memorial Sloan-Kettering Cancer CenterLink provided by the sponsor.
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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.
Jason Konner, MD principal investigator
Memorial Sloan Kettering Cancer 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 Paclitaxel,Cisplatin, Bevacizumab in people with Ovarian Cancer and Primary PERITONEUM, run by Memorial Sloan Kettering Cancer Center 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 20 inclusion and 26 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 20 Jan 2016. 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 20 Jan 2016). 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 Objective Response (time frame: 2 years). 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 20 Jan 2016.