Ovarian CancerPhase 1NCT00059618
PS-341 Plus Carboplatin in Platinum and Taxane Resistant Recurrent Ovarian Cancer, Primary Peritoneal Cancer, and Fallopian Tube Cancer
A Phase 1 study testing PS-341 (Bortezomib) and Carboplatin in people with Ovarian Cancer and Primary Peritoneal Cancer, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial summary
The goal of this clinical research study is to find the highest safe dose of PS-341 that can be given with carboplatin chemotherapy as a treatment for patients with ovarian, abdominal, or fallopian tube cancer. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Ovarian Cancer, Primary Peritoneal Cancer, Fallopian Tube Cancer
- What is being tested?
- PS-341 (Bortezomib) and Carboplatin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2003to Apr 2007
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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 Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients must have histologically-confirmed ovarian cancer, primary peritoneal cancer, or fallopian tube cancer with advanced and/or metastatic disease. All patients must be considered platinum- and taxane- resistant.
- Platinum resistance is defined as:
- Progression of disease during platinum or taxane chemotherapy, or
- Progression of disease within 6 months of completing platinum or taxane chemotherapy
- Failure to achieve a complete response, with persistent macroscopic disease, after 6 cycles of chemotherapy, if the last two cycles had no measurable change in disease status
- Patients may have had any number of prior chemotherapy regimens, except high dose chemotherapy an/or peripheral blood stem cell transplantation (high dose: higher than the standard doses of chemotherapy)
Show all 16Show fewer
- Patients must have measurable disease.
- Zubrod performance status of < 2.
- Patients must give voluntary written informed consent before performance of any study-related procedure not part of normal medical care.
- Adequate liver, renal and bone marrow function, defined as:
- Absolute neutrophil count (ANC) > 1.5 x 10^9/L.
- Platelets > 100 x 10^9/L
- Total bilirubin < 1.7 umol/L
- Alanine transaminase (ALT) and aspartate transaminase (AST) < 1.5 x Upper Limits of Normal (ULN)
- Alkaline phosphatase < 2.5 x ULN.
- Serum creatinine < 1.5 x ULN.
Who cannot join
- Chemotherapy within four weeks of first course of PS-341. (Patients may have been on hormonal therapy).
- Patients who previously received high-dose chemotherapy (higher than the standard doses of chemotherapy) and/or peripheral blood stem cell transplantation.
- Radiation therapy within four weeks of enrollment (excepting palliative XRT).
- Patients not recovered from toxic effects of previous chemotherapy, radiation therapy, or antibody therapy.
- Patients with > Grade 2 peripheral neuropathy.
- Surgery within four weeks of study enrollment.
Show all 16Show fewer
- History of severe hypersensitivity reaction to carboplatin
- Electrocardiographic evidence of acute ischemia or new conduction system abnormalities.
- Myocardial infarction within six months of enrollment.
- Patients with brain metastases or central nervous system disease as evidenced by clinical symptoms.
- History of other malignancy, except nonmelanoma skin cancer or carcinoma in-situ of the cervix, unless in complete remission and off all therapy for that disease for a minimum of 5 years. Chemotherapy given for prior cancers will not exclude patients from participating in this study.
- Patients with previously documented human immunodeficiency virus (HIV) infection. HIV-positive patients are excluded from the study based on theoretical concerns regarding the effect of PS-341 on certain aspects of immune function. NF-KB is a critical T cell activation protein (including through CD40L/CD 154 stimulation) and also is involved in cytokine production. Because PS 341 effectively blocks NF-KB and therefore could reduce or block the ability of T lymphocytes and other immune cells to fight HIV, PS-341 should not be administered to HIV-positive patients. Additional experiments in animal models are being conducted to better elucidate the effects of PS-341 on HIV.
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, or cardiac arrhythmia.
- Other serious medical or psychiatric illness that could, in the investigator's opinion, potentially interfere with the completion of treatment according to this protocol.
- Patients who are pregnant, suspected to be pregnant, or breast-feeding.
- Patients with a known hypersensitivity to PS-341, boron, or mannitol.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Texas M. D. Anderson Cancer Center
Houston, Texas, 77030
About this study
Official title: A Phase I Study Evaluating the Safety and Tolerability of PS-341(Bortezomib)and Carboplatin in Patients With Platinum- and Taxane-Resistant Recurrent Ovarian Cancer, Primary Peritoneal Cancer, and Fallopian Tube Cancer
The goal of this clinical research study is to find the highest safe dose of PS-341 that can be given with carboplatin chemotherapy as a treatment for patients with ovarian, abdominal, or fallopian tube cancer. Researchers also hope to find out if giving these drugs together will help shrink or slow the growth of tumors in patients who are considered resistant to platinum drugs. The safety of these drugs will also be studied.
Read the detailed description
Bortezomib is a drug that turns off certain genes and proteins inside the cancer cell that are responsible for cell growth. Researchers believe that when certain genes and proteins are turned off, the ability of the cancer cell to survive is decreased.
Before treatment starts, participants will have a complete checkup, blood tests, a urine test, a heart test, a chest x-ray, and either a CT scan or MRI scan. Women able to have children must have a negative blood pregnancy test within 14 days of beginning treatment. Blood tests and a complete checkup will also be done before each course of therapy and a month after treatment ends. Approximately 2-3 teaspoons of blood will be obtained for routine blood tests each time blood is drawn during this study.
Participants in this study will receive Bortezomib and carboplatin through a catheter (tube) placed in a vein. This is Day 1 of therapy. Bortezomib is given first (over 5 to 10 seconds) followed by carboplatin (over one hour). Bortezomib is then given alone on Days 4, 8, and 11. There is no treatment given on Days 12-28. One course of therapy is 28 days long and includes one dose of carboplatin and 4 doses of Bortezomib. All treatment is given on an outpatient basis at M. D. Anderson.
There are 4 different dose levels of Bortezomib being studied. The dose of Bortezomib that participants receive will depend on when they are enrolled. It will also depend on whether or not other participants had side effects from their treatment. Up to 6 patients could be treated at each dose.
Before each course of therapy, participants will have a physical exam and blood tests. A CT scan or MRI scan is repeated after Cycles 2 and 4 and at the end of treatment. Participants who have a partial or complete response (the tumor shrinks by more than 50% or disappears completely) will have a repeat CT or MRI 4 weeks later to confirm the response.
Participants may receive up to 8 courses of treatment. If the disease gets worse or if intolerable side effects occur, participants will be taken off study.
This is an investigational study. Bortezomib is approved for use by the FDA, in patients with multiple myeloma. Carboplatin is approved by the FDA, though its use with Bortezomib is experimental. A total of 24 patients will take part in this study. All will be enrolled at M. D. Anderson.
- Being tested
- PS-341 (Bortezomib), Carboplatin
- Keywords
- Platinum Resistant, Taxane Resistant, Ovarian Cancer, Primary Peritoneal Cancer, Fallopian Tube Cancer, Bortezomib, PS-341, Velcade, LDP-341, MLN341, Carboplatin, Paraplatin
- 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.
PS-341 (Bortezomib)Drug
Also called Velcade, LDP-341, MLN341
Starting dose 0.8 mg/m^2 given by vein over 5-10 seconds Day 1, 4, 8 and 11 of 28 day cycle for 8 cycles.
CarboplatinDrug
Also called Paraplatin
AUC 5 by vein administered over one hour Day 1 of 28 day cycle for 8 cycles.
| Study group | Role | What they receive |
|---|---|---|
| Bortezomib | Experimental | PS-341 (Bortezomib) 0.8-1.5 mg/m^2 IV push + Carboplatin (AUC 5) IV on Day 1 of each cycle, then Bortezomib alone on Days 4, 8 and 11 in each 28 day cycle. Receives: Drug: PS-341 (Bortezomib); Drug: Carboplatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum Tolerated Dose (MTD) of Bortezomib with Carboplatin Chemotherapy
Measured: Assessed Day 21 of each 28 Day cycle, up to 4 cohorts for a total of 8 cycles
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2003 (estimated)
- Study startApr 2003
- Primary completionApr 2007
- Study completionApr 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ovarian CancerStudies of the same condition, open and under way.
- More trials run by M.D. Anderson 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 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- Millennium Pharmaceuticals, Inc.
- Responsible party
- Sponsor
- Investigators
- Pedro T. Ramirez, MD, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00059618
- Sponsor's protocol ID
- ID02-114
- Status last verified
- Aug 2012
- First submitted
- 29 Apr 2003
- Last updated
- 2 Aug 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Aug 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Study Evaluating the Safety and Tolerability of PS-341(Bortezomib)and Carboplatin in Patients With Platinum- and Taxane-Resistant Recurrent Ovarian Cancer, Primary Peritoneal Cancer, and Fallopian Tube Cancer
- ClinicalTrials.gov ID
- NCT00059618
- Acronym / sponsor ID
- ID02-114
- Keywords
- Platinum Resistant, Taxane Resistant, Ovarian Cancer, Primary Peritoneal Cancer, Fallopian Tube Cancer, Bortezomib, PS-341, Velcade
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Collaborators
- Millennium Pharmaceuticals, Inc.
- Study start
- Apr 2003
- Primary completion
- Apr 2007 (actual)
- Study completion
- Apr 2007 (actual)
- First posted
- 30 Apr 2003 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this clinical research study is to find the highest safe dose of PS-341 that can be given with carboplatin chemotherapy as a treatment for patients with ovarian, abdominal, or fallopian tube cancer. Researchers also hope to find out if giving these drugs together will help shrink or slow the growth of tumors in patients who are considered resistant to platinum drugs. The safety of these drugs will also be studied.
Detailed description
Bortezomib is a drug that turns off certain genes and proteins inside the cancer cell that are responsible for cell growth. Researchers believe that when certain genes and proteins are turned off, the ability of the cancer cell to survive is decreased.
Before treatment starts, participants will have a complete checkup, blood tests, a urine test, a heart test, a chest x-ray, and either a CT scan or MRI scan. Women able to have children must have a negative blood pregnancy test within 14 days of beginning treatment. Blood tests and a complete checkup will also be done before each course of therapy and a month after treatment ends. Approximately 2-3 teaspoons of blood will be obtained for routine blood tests each time blood is drawn during this study.
Participants in this study will receive Bortezomib and carboplatin through a catheter (tube) placed in a vein. This is Day 1 of therapy. Bortezomib is given first (over 5 to 10 seconds) followed by carboplatin (over one hour). Bortezomib is then given alone on Days 4, 8, and 11. There is no treatment given on Days 12-28. One course of therapy is 28 days long and includes one dose of carboplatin and 4 doses of Bortezomib. All treatment is given on an outpatient basis at M. D. Anderson.
There are 4 different dose levels of Bortezomib being studied. The dose of Bortezomib that participants receive will depend on when they are enrolled. It will also depend on whether or not other participants had side effects from their treatment. Up to 6 patients could be treated at each dose.
Before each course of therapy, participants will have a physical exam and blood tests. A CT scan or MRI scan is repeated after Cycles 2 and 4 and at the end of treatment. Participants who have a partial or complete response (the tumor shrinks by more than 50% or disappears completely) will have a repeat CT or MRI 4 weeks later to confirm the response.
Participants may receive up to 8 courses of treatment. If the disease gets worse or if intolerable side effects occur, participants will be taken off study.
This is an investigational study. Bortezomib is approved for use by the FDA, in patients with multiple myeloma. Carboplatin is approved by the FDA, though its use with Bortezomib is experimental. A total of 24 patients will take part in this study. All will be enrolled at M. D. Anderson.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Bortezomib | Experimental | Drug: PS-341 (Bortezomib), Drug: CarboplatinPS-341 (Bortezomib) 0.8-1.5 mg/m^2 IV push + Carboplatin (AUC 5) IV on Day 1 of each cycle, then Bortezomib alone on Days 4, 8 and 11 in each 28 day cycle. |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (16 listed)
- Patients must have histologically-confirmed ovarian cancer, primary peritoneal cancer, or fallopian tube cancer with advanced and/or metastatic disease. All patients must be considered platinum- and taxane- resistant.
- Platinum resistance is defined as:
- Patients may have had any number of prior chemotherapy regimens, except high dose chemotherapy an/or peripheral blood stem cell transplantation (high dose: higher than the standard doses of chemotherapy)
- Patients must have measurable disease.
- Zubrod performance status of < 2.
Key exclusion criteria (16 listed)
- Chemotherapy within four weeks of first course of PS-341. (Patients may have been on hormonal therapy).
- Patients who previously received high-dose chemotherapy (higher than the standard doses of chemotherapy) and/or peripheral blood stem cell transplantation.
- Radiation therapy within four weeks of enrollment (excepting palliative XRT).
- Patients not recovered from toxic effects of previous chemotherapy, radiation therapy, or antibody therapy.
- Patients with > Grade 2 peripheral neuropathy.
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 |
|---|---|---|
| PS-341 (Bortezomib)Also: Velcade, LDP-341, MLN341Starting dose 0.8 mg/m^2 given by vein over 5-10 seconds Day 1, 4, 8 and 11 of 28 day cycle for 8 cycles. | Drug | Bortezomib |
| CarboplatinAlso: ParaplatinAUC 5 by vein administered over one hour Day 1 of 28 day cycle for 8 cycles. | Drug | Bortezomib |
Primary outcome
Maximum Tolerated Dose (MTD) of Bortezomib with Carboplatin Chemotherapy
Time frame: Assessed Day 21 of each 28 Day cycle, up to 4 cohorts for a total of 8 cycles
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Aug 2012.
- UT MD Anderson Cancer Center websiteLink provided by the sponsor.
Related trials for Ovarian Cancer
Recruiting
Methylation Profiling in Self-Samples for Identification of (Epi)Genetic Biomarkers for Gynecological Cancers
Gynaecological Cancers, Ovarian Cancer
Recruiting
A Study to Compare Two Surgical Procedures in Individuals With BRCA1 Mutations to Assess Reduced Risk of Ovarian Cancer
Ovarian Carcinoma
RecruitingPhase 2
Investigation of Ubamatamab Combination Therapy in Adult Participants With Platinum-Resistant Ovarian Cancer
Ovarian Cancer, Fallopian Tube Cancer
Active, not recruitingPhase 1/2
Phase I/II Study of the Anti-Programmed Death Ligand-1 Durvalumab Antibody (MEDI4736) in Combination With Olaparib and/or Cediranib for Advanced Solid Tumors and Advanced or Recurrent Ovarian, Triple Negative Breast, Lung, Prostate and Colorectal Can...
Colorectal Neoplasms, Breast Neoplasms
Recruiting
The Vanguard Study: Testing a New Way to Screen for Cancer
Bladder Carcinoma, Breast Carcinoma
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.
Pedro T. Ramirez, MD principal investigator
M.D. Anderson 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 PS-341 (Bortezomib) and Carboplatin in people with Ovarian Cancer and Primary Peritoneal Cancer, run by M.D. Anderson 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 16 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 2 Aug 2012. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Maximum Tolerated Dose (MTD) of Bortezomib with Carboplatin Chemotherapy (time frame: Assessed Day 21 of each 28 Day cycle, up to 4 cohorts for a total of 8 cycles). 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 2 Aug 2012.