Ovarian CancerPhase 2NCT00230542
Carboplatin and Pemetrexed in Recurrent Platinum Sensitive Ovarian Cancer
A Phase 2 study testing Carboplatin and Pemetrexed in people with Ovarian Cancer and Peritoneal Cancer, run by Dana-Farber Cancer Institute at 3 sites in United States.
Trial summary
The purpose of this study is to determine the effects (good and bad) the combination of carboplatin and pemetrexed have on patients with recurrent ovarian, peritoneal, or fallopian tube cancer. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Ovarian Cancer, Peritoneal Cancer, Fallopian Tube Cancer
- What is being tested?
- Carboplatin and Pemetrexed
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 3 sitesUnited States
- Study dates
- Sep 2005to Apr 2011
- Phase
- Phase 2
- 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 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of platinum-sensitive recurrence of epithelial ovarian cancer, primary peritoneal cancer, or fallopian tube cancer
- The following histologic subtypes are eligible: papillary serous, endometrioid, mucinous, clear cell, adenocarcinomas, transitional, and mixtures of the above.
- At least one measurable lesion according to RECIST criteria via CT or MRI scan
- Received a platinum-containing regimen at initial diagnosis
- ECOG performance status of 0,1 or 2
- 18 years of age or older
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- Life expectancy of greater than 12 weeks
- WBC > 1,500/mm3
- Neutrophils > 1,500/mm3
- Platelets > 100,000/mm3
- Total Bilirubin < 1.5 ULN
- Calculated creatinine clearance > 45 ml/min
- ALT/AST < 3 x ULN (no liver mets) ALT/AST < 5 x ULN (with liver mets)
- Complete recovery from completion of previous chemotherapy or biologic therapy
- Negative pregnancy test and agree to practice effective method of birth control
Who cannot join
- Patients with sarcomatous, stromal, or germ cell elements
- Prior pelvic radiotherapy > 25% of bone marrow
- Uncontrolled medical problem that in the opinion of the investigator would preclude safe administration of the study drugs
- Past history of bone marrow transplantation or stem cell support
- Known history of CNS metastasis unless the patient has had treatment with surgery or radiation therapy, is neurologically stable, and does not require oral or intravenous corticosteroids or anticonvulsants
- Prior malignancy except adequately treated carcinoma in situ of the uterine cervix, incidental stage I endometrial cancer, basal cell or squamous cell skin cancer or breast cancer (invasive or ductal carcinoma in situ) of which the patient has been disease-free for at least five years
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- Routine prophylactic use of G-CSF or GM-CSF or blood transfusions within 2 weeks
- Clinically significant cardiac disease as defined by: history of unstable angina within 6 months; history of symptomatic ventricular arrhythmias; history of congestive heart failure; history of myocardial infarction within 6 months
- Uncontrolled hypercalcemia or diabetes mellitus
- Any signs of intestinal obstruction with bowel function and/or nutrition
- Grade 2 or greater peripheral neuropathy
- Participation in an investigational study within three weeks
- History of anaphylactic shock to prior platinum chemotherapy
- History of psychiatric disability or other central nervous system disorder
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Massachusetts General Hospital
Boston, Massachusetts, 02114
Brigham and Women's Hospital
Boston, Massachusetts, 02115
Dana-Farber Cancer Institute
Boston, Massachusetts, 02115
About this study
Official title: Phase II Study of Carboplatin and Pemetrexed in Patients With Recurrent Platinum Sensitive Ovarian, Fallopian Tube or Primary Peritoneal Cancer
The purpose of this study is to determine the effects (good and bad) the combination of carboplatin and pemetrexed have on patients with recurrent ovarian, peritoneal, or fallopian tube cancer.
Read the detailed description
- Before patients receive any chemotherapy treatments they will be given three medications to prevent side effects from the chemotherapy drugs. These medications are vitamin B12, folic acid and dexamethasone.
- Chemotherapy treatments will be given intravenously in the outpatient clinic. Pemetrexed will be given first and will take 10 minutes to infuse followed by carboplatin which will take 30-45 minutes to infuse. These treatments will be repeated once every three weeks for 6 cycles of chemotherapy (18 weeks).
- Before each chemotherapy treatment the following tests and procedures will be performed: physical exam and medical history; evaluation of ability to undertake daily activities; and blood tests.
- After every 2 cycles of chemotherapy (every 6 weeks) patients will have a CT or MRI scan to measure how well their cancer is responding to treatment.
- The study treatment will last for 6 cycles of chemotherapy as long as the tumor does not grow and the patient isn't experiencing any severe side effects.
- Conditions
- Ovarian Cancer, Peritoneal Cancer, Fallopian Tube Cancer
- Being tested
- Carboplatin, Pemetrexed
- Keywords
- platinum-sensitive recurrence, carboplatin, pemetrexed
- 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.
CarboplatinDrug
Also called Paraplatin
Given intravenously following pemetrexed over 30-45 minutes once every three weeks for 6 cycles (18 weeks)
PemetrexedDrug
Also called Alimta
Given intravenously over 30 minutes once every three weeks for 6 cycles (18 weeks)
| Study group | Role | What they receive |
|---|---|---|
| Carboplatin / Pemetrexed | Experimental | Single Arm Study Carboplatin AUC 5 Pemetrexed 500 mg/m2 Receives: Drug: Carboplatin; Drug: Pemetrexed |
What is being measured
The primary outcome is the main question the study is designed to answer.
To assess the response rate of carboplatin in combination with pemetrexed in patients with recurrent platinum-sensitive epithelial ovarian cancer, fallopian tube cancer or peritoneal cancer.
This study has now been published: Matulonis U.A.,Horowitz N, Campos S, Lee H., Lee J., Krasner C., Berlin S., Roche M., Duska L, Pereira L, Kendall D, Penson R. Phase II Study of Carboplatin and Pemetrexed for the Treatment of Platinum-Sensitive Recurrent Ovarian Cancer. J Clin Oncol. 2008:26(35):5761-6
Measured: 2 years
Secondary outcomes (2)
To assess time to progression, progression-free survival, and overall survival in this patient population
to assess toxicities of treatment with combination carboplatin and pemetrexed.
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 posted3 Oct 2005 (estimated)
- Study startSep 2005
- Primary completionJul 2007
- Study completionApr 2011
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 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
- 44 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
- Responsible party
- Principal investigator, Ursula A. Matulonis, MD, Dana-Farber Cancer Institute
- Investigators
- Ursula Matulonis, MD, Principal investigator, Dana-Farber Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00230542
- Sponsor's protocol ID
- 05-220
- Status last verified
- Aug 2018
- First submitted
- 29 Sep 2005
- Last updated
- 13 Aug 2018
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Study of Carboplatin and Pemetrexed in Patients With Recurrent Platinum Sensitive Ovarian, Fallopian Tube or Primary Peritoneal Cancer
- ClinicalTrials.gov ID
- NCT00230542
- Acronym / sponsor ID
- 05-220
- Conditions
- Ovarian Cancer, Peritoneal Cancer, Fallopian Tube Cancer
- Keywords
- platinum-sensitive recurrence, carboplatin, pemetrexed
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Dana-Farber Cancer InstituteUniversity, hospital or other
- Collaborators
- Massachusetts General Hospital, Brigham and Women's Hospital
- Study start
- Sep 2005
- Primary completion
- Jul 2007 (actual)
- Study completion
- Apr 2011 (actual)
- First posted
- 3 Oct 2005 (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 purpose of this study is to determine the effects (good and bad) the combination of carboplatin and pemetrexed have on patients with recurrent ovarian, peritoneal, or fallopian tube cancer.
Detailed description
- Before patients receive any chemotherapy treatments they will be given three medications to prevent side effects from the chemotherapy drugs. These medications are vitamin B12, folic acid and dexamethasone.
- Chemotherapy treatments will be given intravenously in the outpatient clinic. Pemetrexed will be given first and will take 10 minutes to infuse followed by carboplatin which will take 30-45 minutes to infuse. These treatments will be repeated once every three weeks for 6 cycles of chemotherapy (18 weeks).
- Before each chemotherapy treatment the following tests and procedures will be performed: physical exam and medical history; evaluation of ability to undertake daily activities; and blood tests.
- After every 2 cycles of chemotherapy (every 6 weeks) patients will have a CT or MRI scan to measure how well their cancer is responding to treatment.
- The study treatment will last for 6 cycles of chemotherapy as long as the tumor does not grow and the patient isn't experiencing any severe side effects.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Carboplatin / Pemetrexed | Experimental | Drug: Carboplatin, Drug: PemetrexedSingle Arm Study Carboplatin AUC 5 Pemetrexed 500 mg/m2 |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- Diagnosis of platinum-sensitive recurrence of epithelial ovarian cancer, primary peritoneal cancer, or fallopian tube cancer
- The following histologic subtypes are eligible: papillary serous, endometrioid, mucinous, clear cell, adenocarcinomas, transitional, and mixtures of the above.
- At least one measurable lesion according to RECIST criteria via CT or MRI scan
- Received a platinum-containing regimen at initial diagnosis
- ECOG performance status of 0,1 or 2
Key exclusion criteria (14 listed)
- Patients with sarcomatous, stromal, or germ cell elements
- Prior pelvic radiotherapy > 25% of bone marrow
- Uncontrolled medical problem that in the opinion of the investigator would preclude safe administration of the study drugs
- Past history of bone marrow transplantation or stem cell support
- Known history of CNS metastasis unless the patient has had treatment with surgery or radiation therapy, is neurologically stable, and does not require oral or intravenous corticosteroids or anticonvulsants
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: ParaplatinGiven intravenously following pemetrexed over 30-45 minutes once every three weeks for 6 cycles (18 weeks) | Drug | Carboplatin / Pemetrexed |
| PemetrexedAlso: AlimtaGiven intravenously over 30 minutes once every three weeks for 6 cycles (18 weeks) | Drug | Carboplatin / Pemetrexed |
Primary outcome
To assess the response rate of carboplatin in combination with pemetrexed in patients with recurrent platinum-sensitive epithelial ovarian cancer, fallopian tube cancer or peritoneal cancer.
Time frame: 2 years
This study has now been published: Matulonis U.A.,Horowitz N, Campos S, Lee H., Lee J., Krasner C., Berlin S., Roche M., Duska L, Pereira L, Kendall D, Penson R. Phase II Study of Carboplatin and Pemetrexed for the Treatment of Platinum-Sensitive Recurrent Ovarian Cancer. J Clin Oncol. 2008:26(35):5761-6
2 secondary outcomes
To assess time to progression, progression-free survival, and overall survival in this patient population
to assess toxicities of treatment with combination carboplatin and pemetrexed.
Time frame: 2 years
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 13 Aug 2018.
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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.
Ursula Matulonis, MD principal investigator
Dana-Farber Cancer Institute
3 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 Carboplatin and Pemetrexed in people with Ovarian Cancer and Peritoneal Cancer, run by Dana-Farber Cancer Institute at 3 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 15 inclusion and 14 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 13 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 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?
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?
To assess the response rate of carboplatin in combination with pemetrexed in patients with recurrent platinum-sensitive epithelial ovarian cancer, fallopian tube cancer or peritoneal cancer. (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 13 Aug 2018.