Ovarian CancerPhase 1NCT01219777
Neoadjuvant Chemotherapy IV Carboplatin With Weekly Paclitaxel \Bevacizumab for Primary Ovarian
A Phase 1 study testing carboplatin, Bevacizumab and Paclitaxel in people with Ovarian Cancer and Primary Peritoneal Cancer, run by Ritu Salani at 1 site in United States.
Trial summary
The purpose of this study is to determine the maximum tolerated dose (MTD) of intravenous weekly paclitaxel given with intravenous carboplatin and bevacizumab in patients with epithelial ovarian, primary peritoneal, or fallopian tube carcinoma that are to receive neoadjuvant chemotherapy (prior to surgical… Read more about this study
- Who is it for?
- Ages 18 to 90 years, women only
- Conditions the study is for
- Ovarian Cancer, Primary Peritoneal Cancer, Fallopian Tube Cancer
- What is being tested?
- carboplatin, Bevacizumab and Paclitaxel
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2010to May 2015
- Phase
- Phase 1
- 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 90 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- histology,cytologically diagnosed epithelial ovarian, primary peritoneal or fallopian tube cancer
- FIGO (International Federation of Gynecology and Obstetrics stage III or IV disease
- GOG (Gynecologic Oncology Group) Performance Status 0,1,2
- No prior surgery for their malignancy
- Adequate bone marrow function
- Platelet count greater than or equal to 100,000
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- Renal Function: Creatinine < 1.5 institutional upper limit normal
- Hepatic Function: Bilirubin less than 1.5 ULN (upper limit of normal)
- Hepatic Function: SGOT (serum glutamate oxaloacetate transaminase) and Alkaline Phosphate
- Neurologic Function: Neuropathy less than CTCAE (Common Toxicity Criteria for Adverse Effects)grade 1
- Coagulation Functions: INR<1.5 and PTT ,1.2 times the upper limit of normal
- Measurable disease
Who cannot join
- Previous cancer related surgery
- Received prior chemotherapy, immunotherapy, radiotherapy, hormonal therapy or biologic therapy for their ovarian, fallopian tube or primary peritoneal cancer.
- Borderline ovarian tumors, recurrent epithelial ovarian or primary peritoneal cancer or non-epithelial ovarian are not eligible.
- Other cancers within 5 years (other than non-melanoma skin cancer)
- Acute Hepatitis or end stage liver disease
- History of prior gastrointestinal perforation
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- Evidence of abdominal free air not explained by paracentesis
- Sign or symptoms of gastrointestinal obstruction
- Active bleeding or pathologic conditions that carry high risk of bleeding
- CNS (Central Nervous System) disease
- Clinically Significant cardiovascular disease
- Known hypersensitivity to Chinese Hamster ovary cell products or other recombinant human or humanized antibodies
- Clinically significant proteinuria.
- Hypertensive crises or hypertensive encephalopathy
- History of hemoptysis
- Any non-study related invasive procedure within 28 days fo first date of bevacizumab
- GOG performance status 3 or 4
- Patients who are pregnant or nursing.
- Under the age of 18
- Received prior treatment of bevacizumab or any anti-VEGF (vascular endothelial growth factor) drug
Trial locations and contacts
1 site in 1 country.
United States1 site
The Ohio State University Medical Center
Columbus, Ohio, 43210
About this study
Official title: Phase I Evaluation of Intravenous Carboplatin With Weekly Paclitaxel and Bevacizumab in Patients Undergoing Neoadjuvant Chemotherapy for Epithelial Ovarian, Fallopian Tube, and Primary Peritoneal Cancer
The purpose of this study is to determine the maximum tolerated dose (MTD) of intravenous weekly paclitaxel given with intravenous carboplatin and bevacizumab in patients with epithelial ovarian, primary peritoneal, or fallopian tube carcinoma that are to receive neoadjuvant chemotherapy (prior to surgical cytoreduction). Patients will then undergo surgery which will allow an objective measure of response to the above regimen as well as assessment of surgical outcomes.
Read the detailed description
Phase I study proposed to evaluate:
- Tolerability of IV regimen carboplatin, paclitaxel and bevacizumab in the neoadjuvant setting prior to surgery.
- Safety/Toxicity of IV regimen in this patient population
- Treatment is Carboplatin area under the concentration curve (AUC) 5, Bevacizumab 15mg/m2, and starting dose of paclitaxel of 60mg/m2 and will be escalated in intervals of 10mg/m2 to a maximum dose of 80mg/m2.
- Patients will receive cycles 1-3 of carboplatin, bevacizumab, and paclitaxel and then cycle 4 will be carboplatin and paclitaxel followed by surgical intervention within 6 weeks of cycle 4.
- Post surgical treatment per physician discretion
- Being tested
- carboplatin, Bevacizumab, Paclitaxel
- Keywords
- bevacizumab, paclitaxel, carboplatin, ovarian, cancer, fallopian tube, primary peritoneal
- Medical subject headings
- Ovarian Neoplasms, Fallopian Tube Neoplasms, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
carboplatinDrug
Also called Paraplatin®, CBDCA
Carboplatin AUC 5.0 or 6.0 will be administered on day 1 during cycle 1-3. Treatment cycle consists of 21 days duration.
BevacizumabDrug
Also called Avastin
Bevacizumab 15 mg/kg administered on Day 1 during cycle 1-3. Treatment cycle consists of 21 days duration.
PaclitaxelDrug
Also called Taxol, Abraxane
60-80 mg/m2 administered on Day 1, 8 \& 15 during cycle 1-3. Treatment cycle consists of 21 days duration.
| Study group | Role | What they receive |
|---|---|---|
| Carboplatin | Experimental | AUC 5.0 or 6.0 Receives: Drug: carboplatin |
| Bevacizumab | Experimental | 15 mg/kg Receives: Drug: Bevacizumab |
| Paclitaxel | Experimental | 60-80 mg/m2 Receives: Drug: Paclitaxel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tolerated Dose
To determine the maximum tolerated dose of carboplatin AUC5 administered Day 1 Cycles 1-4, weekly paclitaxel 60-80mg/m2 administered on Day 1, 8,and 15 for 3 weeks cycles 1-4, bevacizumab 15mg/kg administered Day 1 Cycles 1-3 prior to surgical intervention.
Measured: Up to 6 months
Secondary outcomes (1)
Toxicity and Response Rates Based on Imaging and Surgical Outcomes
Determine the safety/toxicity of this regimen in this patient population. Estimate the percent of patients undergoing successful cytoreductive surgery to optimal disease (<1 cm greatest tumor diameter) following neoadjuvant chemotherapy with carboplatin, paclitaxel and bevacizumab in patients with epithelial ovarian cancer, primary peritoneal cancer and fallopian tube cancer. Assess the 30 day morbidity and mortality following surgical intervention. To describe the response rate for patients treated with neoadjuvant carboplatin, weekly paclitaxel, and bevacizumab using RECIST and GCIG response criteria prior to surgical intervention. Response was determined per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.
Measured: Up to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Oct 2010 (estimated)
- Study startSep 2010
- Primary completionMay 2012
- Study completionMay 2015
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 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ritu Salani
- Sponsor type
- University, hospital or other
- Collaborators
- Genentech, Inc.
- Responsible party
- Sponsor-investigator, Ritu Salani, Ohio State University Comprehensive Cancer Center
- Investigators
- Ritu Salani, MD, Principal investigator, Ohio State University Comprehensive Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01219777
- Sponsor's protocol ID
- OSU-09149
- Other IDs
- NCI-2012-00512
- Status last verified
- May 2015
- First submitted
- 11 Oct 2010
- Last updated
- 8 Feb 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 8 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I Evaluation of Intravenous Carboplatin With Weekly Paclitaxel and Bevacizumab in Patients Undergoing Neoadjuvant Chemotherapy for Epithelial Ovarian, Fallopian Tube, and Primary Peritoneal Cancer
- ClinicalTrials.gov ID
- NCT01219777
- Acronym / sponsor ID
- OSU-09149
- Keywords
- bevacizumab, paclitaxel, carboplatin, ovarian, cancer, fallopian tube, primary peritoneal
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 9 participants (actual)
- Lead sponsor
- Ritu SalaniUniversity, hospital or other
- Collaborators
- Genentech, Inc.
- Study start
- Sep 2010
- Primary completion
- May 2012 (actual)
- Study completion
- May 2015 (actual)
- First posted
- 13 Oct 2010 (estimated)
- Results
- Posted 29 Jun 2015
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 maximum tolerated dose (MTD) of intravenous weekly paclitaxel given with intravenous carboplatin and bevacizumab in patients with epithelial ovarian, primary peritoneal, or fallopian tube carcinoma that are to receive neoadjuvant chemotherapy (prior to surgical cytoreduction). Patients will then undergo surgery which will allow an objective measure of response to the above regimen as well as assessment of surgical outcomes.
Detailed description
Phase I study proposed to evaluate:
- Tolerability of IV regimen carboplatin, paclitaxel and bevacizumab in the neoadjuvant setting prior to surgery.
- Safety/Toxicity of IV regimen in this patient population
- Treatment is Carboplatin area under the concentration curve (AUC) 5, Bevacizumab 15mg/m2, and starting dose of paclitaxel of 60mg/m2 and will be escalated in intervals of 10mg/m2 to a maximum dose of 80mg/m2.
- Patients will receive cycles 1-3 of carboplatin, bevacizumab, and paclitaxel and then cycle 4 will be carboplatin and paclitaxel followed by surgical intervention within 6 weeks of cycle 4.
- Post surgical treatment per physician discretion
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Carboplatin | Experimental | Drug: carboplatinAUC 5.0 or 6.0 |
| Bevacizumab | Experimental | Drug: Bevacizumab15 mg/kg |
| Paclitaxel | Experimental | Drug: Paclitaxel60-80 mg/m2 |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- histology,cytologically diagnosed epithelial ovarian, primary peritoneal or fallopian tube cancer
- FIGO (International Federation of Gynecology and Obstetrics stage III or IV disease
- GOG (Gynecologic Oncology Group) Performance Status 0,1,2
- No prior surgery for their malignancy
- Adequate bone marrow function
Key exclusion criteria (20 listed)
- Previous cancer related surgery
- Received prior chemotherapy, immunotherapy, radiotherapy, hormonal therapy or biologic therapy for their ovarian, fallopian tube or primary peritoneal cancer.
- Borderline ovarian tumors, recurrent epithelial ovarian or primary peritoneal cancer or non-epithelial ovarian are not eligible.
- Other cancers within 5 years (other than non-melanoma skin cancer)
- Acute Hepatitis or end stage liver disease
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 |
|---|---|---|
| carboplatinAlso: Paraplatin®, CBDCACarboplatin AUC 5.0 or 6.0 will be administered on day 1 during cycle 1-3. Treatment cycle consists of 21 days duration. | Drug | Carboplatin |
| BevacizumabAlso: AvastinBevacizumab 15 mg/kg administered on Day 1 during cycle 1-3. Treatment cycle consists of 21 days duration. | Drug | Bevacizumab |
| PaclitaxelAlso: Taxol, Abraxane60-80 mg/m2 administered on Day 1, 8 \& 15 during cycle 1-3. Treatment cycle consists of 21 days duration. | Drug | Paclitaxel |
Primary outcome
Tolerated Dose
Time frame: Up to 6 months
To determine the maximum tolerated dose of carboplatin AUC5 administered Day 1 Cycles 1-4, weekly paclitaxel 60-80mg/m2 administered on Day 1, 8,and 15 for 3 weeks cycles 1-4, bevacizumab 15mg/kg administered Day 1 Cycles 1-3 prior to surgical intervention.
1 secondary outcome
Toxicity and Response Rates Based on Imaging and Surgical Outcomes
Time frame: Up to 6 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Feb 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- JameslineLink 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.
Ritu Salani, MD principal investigator
Ohio State University Comprehensive 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 1 study testing carboplatin, Bevacizumab and Paclitaxel in people with Ovarian Cancer and Primary Peritoneal Cancer, run by Ritu Salani 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 12 inclusion and 20 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 8 Feb 2018. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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 29 Jun 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?
Tolerated Dose (time frame: Up to 6 months). 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 Feb 2018.