Epithelial Ovarian CancerPhase 2PaLiDoNCT00861120
Panitumumab and Pegylated Liposomal Doxorubicin for Platinum-Resistant Epithelial Ovarian Cancer With KRAS Wild-type
A Phase 2 study testing Pegylated liposomal doxorubicin and Panitumumab in people with Epithelial Ovarian Cancer, run by Vejle Hospital at 6 sites in 4 countries.
Trial summary
The purpose of this study is to investigate the response rate in platinum-resistant, KRAS wild-type, ovarian cancer patients who are treated with pegylated liposomal doxorubicin (Caelyx®) in combination with biological treatment panitumumab (Vectibix®). Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Epithelial Ovarian Cancer
- What is being tested?
- Pegylated liposomal doxorubicin and Panitumumab
- How many people
- 33 participants
- Where
- 6 sitesin 4 countries
- Study dates
- Apr 2009to Aug 2012
- 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
- Histologically confirmed epithelial primary ovarian, primary fallopian or primary peritoneal cancer. Stage I-IV.
- A: First line treatment with a platinum containing regimen with either progression or no response during 1.line chemotherapy, or relapse within 6 months after end of 1. line chemotherapy, OR
- B: Patients receiving second line with a platinum containing regimen with either progression or no response during second line chemotherapy, or relapse within 6 months after end of second line chemotherapy
- Maximum two prior lines of chemotherapy (both platinum-based)
- Age ≥ 18 years.
- Performance status 0-2.
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- Measurable disease by CA125 GCIG criteria
- KRAS wild type
- Adequate bone marrow function, liver function, renal function and coagulation parameters (within 7 days prior to randomization):
- WBC ≥ 3.0 x 109/l or neutrophils (ANC)≥ 1.5 x 109/l
- Platelet count ≥ 100 x 109/l
- Hemoglobin ≥ 9.7 g/dl (6 mmol/L)
- Serum bilirubin ≤ 1.5 x UNL
- Serum transaminases ≤ 2.5 x UNL in absence of liver metastases, or ≤ 5xUNL in presence of liver metastases
- Serum creatinine ≤ 1.5 x UNL
- Magnesium ≥ lower limit of normal
- Calcium ≥ lower limit of normal
- Written informed consent
Who cannot join
- Prior treatment with chemotherapy or biological targeted treatment except 1. line chemotherapy with platinum or combination platinum/taxane (bevacizumab allowed as part of the 1. line treatment).
- Patients who have received (or are planning to receive) treatment with any other investigational agent, or who have participated in another clinical trial within 28 days prior to entering this trial.
- Pregnant or breast-feeding or planning to become pregnant within 6 months after end of treatment. For fertile women a negative pregnancy test at screening is mandatory.
- Fertile patients not willing to use acceptable and safe methods of contraception during and for 6 months following treatment
- Other present or previous malignancy except curatively treated cervical cancer, non-melanotic skin cancer or other cancer with minimal risk of relapse.
- CNS metastasis
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- History of any chronic medical or psychiatric condition or laboratory abnormality that are not medically controlled or in the opinion of the Investigator may increase the risks associated with study drug administration. (e.g. diabetes, cardiac diseases, hypertension).
- Clinically significant cardiovascular disease ≤ 1 year before enrollment/randomization, including:
- Myocardial infarction or unstable angina within 6 months of randomization.
- New York Heart Association (NYHA) ≥ Grade 2 congestive heart failure. Even if medically controlled.
- Poorly controlled cardiac arrhythmia despite Medication (patients with rate-controlled atrial fibrillation are eligible)
- Uncontrolled hypercalcemia (calcium level outside the upper limit of normal; antihypercalcemic treatment is allowed).
- Allergy to the ingredients of the study medication or to Staphylococcus Protein A
- History of interstitial pneumonitis or pulmonary fibrosis or evidence of interstitial lung disease on baseline chest CT scan.
Trial locations and contacts
6 sites in 4 countries.
6 sites in 4 countries
Denmark3 sites
Aalborg Hospital
Aalborg
Herning Regional Hospital
Herning
Vejle Hospital, Dept. of Oncology
Vejle
About this study
Official title: Panitumumab and Pegylated Liposomal Doxorubicin for Platinum-Resistant Epithelial Ovarian Cancer With Kirsten Rat Sarcoma Viral Oncogene Homolog (KRAS) Wild-type
The purpose of this study is to investigate the response rate in platinum-resistant, KRAS wild-type, ovarian cancer patients who are treated with pegylated liposomal doxorubicin (Caelyx®) in combination with biological treatment panitumumab (Vectibix®).
Read the detailed description
Patients with platinum-resistant recurrent ovarian cancer have few therapeutic options and the response rates are only 10-20% using non-cross-resistant chemotherapeutic agents.
New biologic agents in combination with chemotherapy or other treatment modalities may result in improvement in survival.
Recent results in colorectal cancer have clearly indicated that KRAS mutant tumors do not respond to treatment with EGFR inhibitors.
Panitumumab (ABX-EGF) is the first fully human monoclonal antibody specific to the EGF receptor. To date, panitumumab has been evaluated in combination with chemotherapy in patients with CRC, NSCLC, and SCCHN.
No previous studies have evaluated the effect of panitumumab in epithelial ovarian cancer based on KRAS mutation status.
- Conditions
- Epithelial Ovarian Cancer
- Being tested
- Pegylated liposomal doxorubicin, Panitumumab
- Keywords
- Ovarian cancer, KRAS wildtype, Platinum resistant
- Medical subject headings
- Carcinoma, Ovarian Epithelial, Ovarian Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pegylated liposomal doxorubicinDrug
Also called Caelyx
40 mg/m2 on day 1 of a 28 days cycle
PanitumumabDrug
Also called Vectibix
6 mg/kg on days 1 and 15 of a 28 days cycle
What is being measured
The primary outcome is the main question the study is designed to answer.
Response rate
Measured: 6 months.
Secondary outcomes (3)
Progression Free Survival
Measured: 6 months.
Overall survival
Measured: Up to 5 years
Toxicity
Measured: 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 Mar 2009 (estimated)
- Study startApr 2009
- Primary completionAug 2011
- Study completionAug 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Epithelial 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 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 33 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Vejle Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Anders Jakobsen, MD, DMSc, Study chair, Vejle HospitalKarina D. Steffensen, MD, PhD, Principal investigator, Vejle Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00861120
- Sponsor's protocol ID
- 2008-007799-13
- Other IDs
- 2008
- Acronym
- PaLiDo
- Status last verified
- Oct 2012
- First submitted
- 12 Mar 2009
- Last updated
- 26 Oct 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Panitumumab and Pegylated Liposomal Doxorubicin for Platinum-Resistant Epithelial Ovarian Cancer With Kirsten Rat Sarcoma Viral Oncogene Homolog (KRAS) Wild-type
- ClinicalTrials.gov ID
- NCT00861120
- Acronym / sponsor ID
- PaLiDo / 2008-007799-13
- Conditions
- Epithelial Ovarian Cancer
- Keywords
- Ovarian cancer, KRAS wildtype, Platinum resistant
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 33 participants (estimated)
- Lead sponsor
- Vejle HospitalUniversity, hospital or other
- Study start
- Apr 2009
- Primary completion
- Aug 2011 (actual)
- Study completion
- Aug 2012 (actual)
- First posted
- 13 Mar 2009 (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 investigate the response rate in platinum-resistant, KRAS wild-type, ovarian cancer patients who are treated with pegylated liposomal doxorubicin (Caelyx®) in combination with biological treatment panitumumab (Vectibix®).
Detailed description
Patients with platinum-resistant recurrent ovarian cancer have few therapeutic options and the response rates are only 10-20% using non-cross-resistant chemotherapeutic agents.
New biologic agents in combination with chemotherapy or other treatment modalities may result in improvement in survival.
Recent results in colorectal cancer have clearly indicated that KRAS mutant tumors do not respond to treatment with EGFR inhibitors.
Panitumumab (ABX-EGF) is the first fully human monoclonal antibody specific to the EGF receptor. To date, panitumumab has been evaluated in combination with chemotherapy in patients with CRC, NSCLC, and SCCHN.
No previous studies have evaluated the effect of panitumumab in epithelial ovarian cancer based on KRAS mutation status.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Factorial
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (18 listed)
- Histologically confirmed epithelial primary ovarian, primary fallopian or primary peritoneal cancer. Stage I-IV.
- Maximum two prior lines of chemotherapy (both platinum-based)
- Age ≥ 18 years.
- Performance status 0-2.
- Measurable disease by CA125 GCIG criteria
Key exclusion criteria (14 listed)
- Prior treatment with chemotherapy or biological targeted treatment except 1. line chemotherapy with platinum or combination platinum/taxane (bevacizumab allowed as part of the 1. line treatment).
- Patients who have received (or are planning to receive) treatment with any other investigational agent, or who have participated in another clinical trial within 28 days prior to entering this trial.
- Pregnant or breast-feeding or planning to become pregnant within 6 months after end of treatment. For fertile women a negative pregnancy test at screening is mandatory.
- Fertile patients not willing to use acceptable and safe methods of contraception during and for 6 months following treatment
- Other present or previous malignancy except curatively treated cervical cancer, non-melanotic skin cancer or other cancer with minimal risk of relapse.
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 |
|---|---|---|
| Pegylated liposomal doxorubicinAlso: Caelyx40 mg/m2 on day 1 of a 28 days cycle | Drug | – |
| PanitumumabAlso: Vectibix6 mg/kg on days 1 and 15 of a 28 days cycle | Drug | – |
Primary outcome
Response rate
Time frame: 6 months.
3 secondary outcomes
Progression Free Survival
Time frame: 6 months.
Overall survival
Time frame: Up to 5 years
Toxicity
Time frame: 6 months
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 26 Oct 2012.
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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.
Anders Jakobsen, MD, DMSc study chair
Vejle Hospital
Karina D. Steffensen, MD, PhD principal investigator
Vejle Hospital
6 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Pegylated liposomal doxorubicin and Panitumumab in people with Epithelial Ovarian Cancer, run by Vejle Hospital at 6 sites in 4 countries.
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 18 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 26 Oct 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Denmark, Austria, Belgium, Sweden. 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?
Response rate (time frame: 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 26 Oct 2012.