Ovarian CancerPhase 2PROVENCT01388621
Carboplatin-based Chemotherapy With or Without Panitumumab in Platinum-sensitive Recurrent Ovarian Cancer
A Phase 2 study testing Panitumumab, pegylated liposomal doxorubicin (PLD) and Carboplatin in people with Ovarian Cancer, run by WiSP Wissenschaftlicher Service Pharma GmbH at 18 sites in Germany.
Trial summary
The purpose of this trial is to estimate the therapeutic efficacy of the experimental targeted regimen including the EGFR antibody panitumumab (in combination with carboplatin and either pegylated liposomal doxorubicin or gemcitabine) in relation to the respective standard combination in patients with a KRAS wildtype… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Ovarian Cancer
- What is being tested?
- Panitumumab, pegylated liposomal doxorubicin (PLD) and Carboplatin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- 18 sitesGermany
- Study dates
- Oct 2011to Jul 2015
- 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
- Female patients with pretreated epithelial ovarian cancer, primary peritoneal carcinomatosis or fallopian tube cancer with histological confirmation of the tumor
- Wild-type k-ras status
- Patients must have pretreated platinum-sensitive ovarian cancer with recurrence more than 6 months after completion of a platinum-containing regimen
- Presence of at least one measurable or non-measurable disease (e.g. malignant ascites) following RECIST criteria by radiologic evaluation OR histological confirmation of recurrence by biopsy. The presence of non-measurable lesions only requires in addition a 2-fold increase of CA-125 elevation above normal lab value (confirmed by two measurements).
- No more than 2 prior treatment regimens for these epithelial cancers
- Age > 18 years.
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- ECOG Performance Status of 0 or 1
- Adequate bone marrow, liver and renal function as assessed by the following laboratory requirements to be conducted within 7 days prior to screening:
- Hemoglobin > 9.0 g/dl
- Leukocyte count >3.000/mm3 ; absolute neutrophil count (ANC) >1.500/mm3
- Platelet count ≥ 100.000/μl
- Total bilirubin < 1,0 times the upper limit of normal
- ALT and AST < 2,5 x upper limit of normal (< 5 x upper limit of normal for patients with liver involvement of their cancer)
- Alkaline phosphatase < 4 x ULN
- PT-INR/PTT < 1.5 x upper limit of normal [Patients who are being therapeutically anticoagulated with an agent such as coumarin or heparin will be allowed to participate provided that no prior evidence of underlying abnormality in these parameters exists.]
- Serum creatinine < 1.5 x upper limit of normal and creatinine clearance > 50 ml/min.
- Magnesium ≥ lower limit of normal; calcium ≥ lower limit of normal
- Signed and dated informed consent before the start of specific protocol procedures.
Who cannot join
- Clinically significant cardiovascular disease (incl. myocardial infarction, unstable angina, symptomatic congestive heart failure, serious uncontrolled cardiac arrhythmia) ≤ 1 year before enrolment.
- History of interstitial lung disease, e.g. pneumonitis or pulmonary fibrosis or evidence of interstitial lung disease on baseline chest CT scan.
- History of HIV infection or chronic hepatitis B or C
- Active clinically serious infections (> grade 2 NCI-CTC version 3.0)
- Pre-existing neuropathy > grade 1 (NCI CTCAE), except for loss of tendon reflex
- Prior radiological or clinical evidence of CNS metastases including previously treated, resected, or asymptomatic brain lesions or leptomeningeal involvement by head CT scan or MRI
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- Patients with seizure disorder requiring medication (such as steroids or anti-epileptics)
- History of organ allograft
- Patients with evidence or history of bleeding diathesis
- Patients undergoing renal dialysis
- Previous or concurrent cancer that is distinct in primary site or histology from the cancer being evaluated in this study EXCEPT cervical carcinoma in situ, treated basal cell carcinoma, superficial bladder tumors [Ta, Tis \& T1] or any cancer curatively treated > 3 years prior to study entry.
- Patients in a closed institution according to an authority or court decision
- Any condition that is unstable or could jeopardize the safety of the patient and their compliance in the study
- Excluded therapies and medications, previous and concomitant:
- Anticancer chemotherapy within 4 weeks prior to study entry.
- Prior anti-EGFR therapy
- Radiotherapy during study or within 4 weeks of start of study drug. (Palliative radiotherapy of non-target lesions will be allowed) and prior radiotherapy of > 25% of the bone marrow
- Major surgery within 4 weeks of start of study
- Autologous bone marrow transplant or stem cell rescue within 12 months of study
- Investigational drug therapy outside of this trial during or within 4 weeks of study entry
- Substance abuse, medical, psychological or social conditions that may interfere with the patient's participation in the study or evaluation of the study results
Trial locations and contacts
18 sites in 1 country.
18 sites in 1 country
Germany18 sites, 16 recruiting
- Recruiting
Praxisklinik Frauenheilkunde
Berlin, State of Berlin, 10367
Peter Klare, MD (Dr. med.)
- Withdrawn
Helios Klinikum Berlin - Buch
Berlin, State of Berlin, 13125
- Recruiting
Frauenklinik Charité - Universitätsmedizin Berlin Campus Virchow-Klinikum
Berlin, State of Berlin, 13353
Jalid Sehouli, MD (Prof. Dr. med.)
- Recruiting
Ev. Waldkrankenhaus Spandau
Berlin, State of Berlin, 13589
Jochem Potenberg, MD (Dr. med)
- Recruiting
Praxis Dr. Schilling / Till / Kohn FÄ f. Gynäkologie u. Geburtshilfe, Gynäkol.-Onkol. Schwerpunktpraxis
Berlin, 10317
Jörg Schilling, MD (Dr.)
- Recruiting
Gynäkologische Praxis Dr. med. Ruhmland
Berlin, 12683
Birgit Ruhmland, MD (Dr.)
- Recruiting
Park-Klinik Weißensee
Berlin, 13086
Elke Keil, MD (Dr.)
- Recruiting
Medizinisches Zentrum Bonn-Friedensplatz
Bonn, North Rhine-Westphalia, 53111
Christian M Kurbacher, MD (PD Dr. med.)
- Recruiting
Klinikum Chemnitz Frauen- und Kinderklinik
Chemnitz, Saxony, 09116
Petra Krabisch, MD (Dr. med.)
- Recruiting
Carl-Thiem-Klinikum Cottbus Frauenklinik
Cottbus, Brandenburg, 03048
Andrzej Popiela, MD (Dr. med.)
- Recruiting
Praxis Dr. Oettle
Friedrichshafen, Baden-Wurttemberg, 88045
Helmut Oettle, MD (PD Dr. med.)
- Recruiting
Praxis Dr. Heinrich
Fürstenwalde, Brandenburg, 15517
Georg Heinrich, MD (Dr. med.)
- Recruiting
Martin-Luther-Universität Halle-Wittenberg Zentrum für Frauenheilkunde und Geburtshilfe
Halle, Saxony-Anhalt, 06120
Hans-Georg Strauss, MD (Dr. med.)
- Recruiting
Tagesklinik Altonaer Strasse
Hamburg, Free and Hanseatic City of Hamburg, 20357
Andreas Nugent, MD (Dr. med.)
- Recruiting
MVM mbH Onkologische Schwerpunktpraxis Leer
Leer, Lower Saxony, 26789
Lothar Müller, MD (Dr. med.)
- Recruiting
Klinikum Magdeburg
Magdeburg, Saxony-Anhalt, 39130
Christoph Kahl, MD (PD Dr. med.)
- Recruiting
Stauferklinikum Schwäbisch Gmünd
Mutlangen, Baden-Wurttemberg, 73557
Ekkehard von Abel, Dr. med
- Withdrawn
Universitätsfrauenklinik am Klinikum Südstadt
Rostock, Mecklenburg-Vorpommern, 18059
About this study
Official title: PROVE A Randomized Phase II Trial of Standard Carboplatin-based Chemotherapy With or Without Panitumumab in Platinum-sensitive Recurrent Ovarian Cancer
The purpose of this trial is to estimate the therapeutic efficacy of the experimental targeted regimen including the EGFR antibody panitumumab (in combination with carboplatin and either pegylated liposomal doxorubicin or gemcitabine) in relation to the respective standard combination in patients with a KRAS wildtype with platinum-sensitive recurrent ovarian cancer. It is expected that the progression free survival rate at 12 months is improved by the targeted regimen.
- Conditions
- Ovarian Cancer
- Being tested
- Panitumumab, pegylated liposomal doxorubicin (PLD), Carboplatin, Gemcitabine
- Keywords
- ovarian cancer, fallopian cancer, recurrent, platinum-sensitive, KRAS-Wildtype
- Medical subject headings
- Ovarian Neoplasms, Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PanitumumabDrug
Also called Vectibix
Panitumumab 6 mg/kg/BW d1 + 15 q4w until progressive disease or for a max. of 6 cycles In case of CR, PR or SD at the end of the combination treatment in experimental arm, panitumumab monotherapy is to be continued with 9 mg/kg/BW d1 q3w until time of tumor progression or up to a maximum of 6 months.
pegylated liposomal doxorubicin (PLD)Drug
Also called Caelyx
pegylated liposomal doxorubicin (PLD) 30 mg/m² d1 q4w until progressive disease or for a max. of 6 cycles
CarboplatinDrug
Also called multiple generics in existence
Carboplatin AUC 5 d1 q4w until progressive disease or for a max. of 6 cycles
GemcitabineDrug
Also called Gemzar
gemcitabine 1000 mg/m² d1 + 8 q3w until progressive disease or for a max. of 6 cycles
CarboplatinDrug
Also called multiple generics in existence
Carboplatin AUC 4 d1 q3w until progressive disease or for a max. of 6 cycles
PanitumumabDrug
Also called Vectibix
Panitumumab 9 mg/kg/BW d1 q3w until progressive disease or for a max. of 6 cycles In case of CR, PR or SD at the end of the combination treatment in experimental arm, panitumumab monotherapy is to be continued with 9 mg/kg/BW d1 q3w until time of tumor progression or up to a maximum of 6 months.
| Study group | Role | What they receive |
|---|---|---|
| Experimental arm (A): | Experimental | Caelyx 30 mg/m² d1 Carboplatin AUC 5 d1 Panitumumab 6 mg/kg/KG d1 + 15 q4w until progressive disease or for a max. of 6 cycles
OR
Gemcitabine 1000 mg/m² d1 + 8 Carboplatin AUC 4 d1 Panitumumab 9 mg/kg/KG d1 q3w until progressive disease or for a max. of 6 cycles
The backbone chemotherapy (Caelyx or Gemcitabine-based) is specified by the investigator before randomization of a patient. Receives: Drug: Panitumumab; Drug: pegylated liposomal doxorubicin (PLD); Drug: Carboplatin; Drug: Gemcitabine |
| Standard arm (B): | Active comparator | Caelyx 30 mg/m² d1 Carboplatin AUC 5 d1 q4w until progressive disease or for a max. of 6 cycles
OR
Gemcitabine 1000 mg/m² d1 + 8 Carboplatin AUC 4 d1 q3w until progressive disease or for a max. of 6 cycles
The backbone chemotherapy (Caelyx or Gemcitabine-based) is specified by the investigator before randomization of a patient. Receives: Drug: pegylated liposomal doxorubicin (PLD); Drug: Carboplatin; Drug: Gemcitabine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-free survival (PFS) rate after 12 months.
PFS is defined as the time from randomisation to the time of disease progression or relapse (according to RECIST, not CA-125 only!) or death, or to the date of last tumor assessment without any such event (censored observation).
Measured: 12 month
Secondary outcomes (5)
Duration of Tumor-Response
according to RECIST, including measurable disease patients only, and including patients with CA-125 defined disease as well
Measured: Duration of Therapy (Therapy is planned for 6 cycles of 3 resp. 4 weeks each, shorter or longer durations are possible)
Progression-free survival
Measured: End of Follow-up (up to 1 year)
Overall survival
Measured: End of Follow-up (up to 1 year)
Maximum toxicity resp. AE grade per patient per toxicity resp. AE during therapy
Toxicities resp. (S)AE during therapy will be documented, reported and analyzed according to NCI CTC 3.0 with special focus on skin toxicity.
Results are given as maximum grade per patient per toxicity resp. AE during therapy.
Measured: Duration of Therapy (Therapy is planned for 6 cycles of 3 resp. 4 weeks each, shorter or longer durations are possible)
Tumor Response Rate
according to RECIST, including measurable disease patients only, and including patients with CA-125 defined disease as well
Measured: Duration of Therapy (Therapy is planned for 6 cycles of 3 resp. 4 weeks each, shorter or longer durations are possible)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jul 2011 (estimated)
- Study startOct 2011
- Primary completionJul 2014 (estimated)
- Study completionJul 2015 (estimated)
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.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 140 participants (estimated)
Sponsor and investigators
- Lead sponsor
- WiSP Wissenschaftlicher Service Pharma GmbH
- Sponsor type
- University, hospital or other
- Collaborators
- ClinAssess GmbH
- Responsible party
- Sponsor
- Investigators
- Jalid Sehouli, MD (Prof. Dr. med.), Principal investigator, Frauenklinik Charité - Universitätsmedizin Berlin Campus Virchow-Klinikum
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01388621
- Sponsor's protocol ID
- GMIHO-008/2009_AG56
- Other IDs
- 2010-018849-59
- Acronym
- PROVE
- Status last verified
- Aug 2013
- First submitted
- 17 May 2011
- Last updated
- 20 Aug 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PROVE A Randomized Phase II Trial of Standard Carboplatin-based Chemotherapy With or Without Panitumumab in Platinum-sensitive Recurrent Ovarian Cancer
- ClinicalTrials.gov ID
- NCT01388621
- Acronym / sponsor ID
- PROVE / GMIHO-008/2009_AG56
- Conditions
- Ovarian Cancer
- Keywords
- ovarian cancer, fallopian cancer, recurrent, platinum-sensitive, KRAS-Wildtype
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 140 participants (estimated)
- Lead sponsor
- WiSP Wissenschaftlicher Service Pharma GmbHUniversity, hospital or other
- Collaborators
- ClinAssess GmbH
- Study start
- Oct 2011
- Primary completion
- Jul 2014 (estimated)
- Study completion
- Jul 2015 (estimated)
- First posted
- 6 Jul 2011 (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 trial is to estimate the therapeutic efficacy of the experimental targeted regimen including the EGFR antibody panitumumab (in combination with carboplatin and either pegylated liposomal doxorubicin or gemcitabine) in relation to the respective standard combination in patients with a KRAS wildtype with platinum-sensitive recurrent ovarian cancer. It is expected that the progression free survival rate at 12 months is improved by the targeted regimen.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental arm (A): | Experimental | Drug: Panitumumab, Drug: pegylated liposomal doxorubicin (PLD), Drug: Carboplatin, Drug: GemcitabineCaelyx 30 mg/m² d1 Carboplatin AUC 5 d1 Panitumumab 6 mg/kg/KG d1 + 15 q4w until progressive disease or for a max. of 6 cycles OR Gemcitabine 1000 mg/m² d1 + 8 Carboplatin AUC 4 d1 Panitumumab 9 mg/kg/KG d1 q3w until progressive disease or for a max. of 6 cycles The backbone chemotherapy (Caelyx or Gemcitabine-based) is specified by the investigator before randomization of a patient. |
| Standard arm (B): | Active comparator | Drug: pegylated liposomal doxorubicin (PLD), Drug: Carboplatin, Drug: GemcitabineCaelyx 30 mg/m² d1 Carboplatin AUC 5 d1 q4w until progressive disease or for a max. of 6 cycles OR Gemcitabine 1000 mg/m² d1 + 8 Carboplatin AUC 4 d1 q3w until progressive disease or for a max. of 6 cycles The backbone chemotherapy (Caelyx or Gemcitabine-based) is specified by the investigator before randomization of a patient. |
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)
- Female patients with pretreated epithelial ovarian cancer, primary peritoneal carcinomatosis or fallopian tube cancer with histological confirmation of the tumor
- Wild-type k-ras status
- Patients must have pretreated platinum-sensitive ovarian cancer with recurrence more than 6 months after completion of a platinum-containing regimen
- Presence of at least one measurable or non-measurable disease (e.g. malignant ascites) following RECIST criteria by radiologic evaluation OR histological confirmation of recurrence by biopsy. The presence of non-measurable lesions only requires in addition a 2-fold increase of CA-125 elevation above normal lab value (confirmed by two measurements).
- No more than 2 prior treatment regimens for these epithelial cancers
Key exclusion criteria (21 listed)
- Clinically significant cardiovascular disease (incl. myocardial infarction, unstable angina, symptomatic congestive heart failure, serious uncontrolled cardiac arrhythmia) ≤ 1 year before enrolment.
- History of interstitial lung disease, e.g. pneumonitis or pulmonary fibrosis or evidence of interstitial lung disease on baseline chest CT scan.
- History of HIV infection or chronic hepatitis B or C
- Active clinically serious infections (> grade 2 NCI-CTC version 3.0)
- Pre-existing neuropathy > grade 1 (NCI CTCAE), except for loss of tendon reflex
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 |
|---|---|---|
| PanitumumabAlso: VectibixPanitumumab 6 mg/kg/BW d1 + 15 q4w until progressive disease or for a max. of 6 cycles In case of CR, PR or SD at the end of the combination treatment in experimental arm, panitumumab monotherapy is to be continued with 9 mg/kg/BW d1 q3w until time of tumor progression or up to a maximum of 6 months. | Drug | Experimental arm (A): |
| pegylated liposomal doxorubicin (PLD)Also: Caelyxpegylated liposomal doxorubicin (PLD) 30 mg/m² d1 q4w until progressive disease or for a max. of 6 cycles | Drug | Experimental arm (A):, Standard arm (B): |
| CarboplatinAlso: multiple generics in existenceCarboplatin AUC 5 d1 q4w until progressive disease or for a max. of 6 cycles | Drug | Experimental arm (A):, Standard arm (B): |
| GemcitabineAlso: Gemzargemcitabine 1000 mg/m² d1 + 8 q3w until progressive disease or for a max. of 6 cycles | Drug | Experimental arm (A):, Standard arm (B): |
| CarboplatinAlso: multiple generics in existenceCarboplatin AUC 4 d1 q3w until progressive disease or for a max. of 6 cycles | Drug | Experimental arm (A):, Standard arm (B): |
| PanitumumabAlso: VectibixPanitumumab 9 mg/kg/BW d1 q3w until progressive disease or for a max. of 6 cycles In case of CR, PR or SD at the end of the combination treatment in experimental arm, panitumumab monotherapy is to be continued with 9 mg/kg/BW d1 q3w until time of tumor progression or up to a maximum of 6 months. | Drug | Experimental arm (A): |
Primary outcome
Progression-free survival (PFS) rate after 12 months.
Time frame: 12 month
PFS is defined as the time from randomisation to the time of disease progression or relapse (according to RECIST, not CA-125 only!) or death, or to the date of last tumor assessment without any such event (censored observation).
5 secondary outcomes
Duration of Tumor-Response
Time frame: Duration of Therapy (Therapy is planned for 6 cycles of 3 resp. 4 weeks each, shorter or longer durations are possible)
Progression-free survival
Time frame: End of Follow-up (up to 1 year)
Overall survival
Time frame: End of Follow-up (up to 1 year)
Maximum toxicity resp. AE grade per patient per toxicity resp. AE during therapy
Time frame: Duration of Therapy (Therapy is planned for 6 cycles of 3 resp. 4 weeks each, shorter or longer durations are possible)
Tumor Response Rate
Time frame: Duration of Therapy (Therapy is planned for 6 cycles of 3 resp. 4 weeks each, shorter or longer durations are possible)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2013.
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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.
Jalid Sehouli, MD (Prof. Dr. med.) principal investigator
Frauenklinik Charité - Universitätsmedizin Berlin Campus Virchow-Klinikum
18 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 Panitumumab, pegylated liposomal doxorubicin (PLD) and Carboplatin in people with Ovarian Cancer, run by WiSP Wissenschaftlicher Service Pharma GmbH at 18 sites in Germany.
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 21 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: status not confirmed, as of the sponsor's last update on 20 Aug 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 18 sites in Germany. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Nadine Albers (0351-25933-281, nadine.albers@gmiho.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression-free survival (PFS) rate after 12 months. (time frame: 12 month). 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 Aug 2013; AzTrials last refreshed its copy on 6 Nov 2026.