Carboplatin-based Chemotherapy With or Without Panitumumab in Platinum-sensitive Recurrent Ovarian Cancer (PROVE)
This study is currently recruiting participants.
Verified March 2013 by WiSP Wissenschaftlicher Service Pharma GmbH
Sponsor:
WiSP Wissenschaftlicher Service Pharma GmbH
Collaborator:
ClinAssess GmbH
Information provided by (Responsible Party):
WiSP Wissenschaftlicher Service Pharma GmbH
ClinicalTrials.gov Identifier:
NCT01388621
First received: May 17, 2011
Last updated: March 12, 2013
Last verified: March 2013
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Ovarian Cancer |
Drug: Panitumumab Drug: pegylated liposomal doxorubicin (PLD) Drug: Carboplatin Drug: Gemcitabine |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | PROVE A Randomized Phase II Trial of Standard Carboplatin-based Chemotherapy With or Without Panitumumab in Platinum-sensitive Recurrent Ovarian Cancer |
Resource links provided by NLM:
Drug Information available for:
Doxorubicin
Doxorubicin hydrochloride
Carboplatin
Gemcitabine
Gemcitabine hydrochloride
Panitumumab
U.S. FDA Resources
Further study details as provided by WiSP Wissenschaftlicher Service Pharma GmbH:
Primary Outcome Measures:
- Progression-free survival (PFS) rate after 12 months. [ Time Frame: 12 month ] [ Designated as safety issue: No ]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).
Secondary Outcome Measures:
- 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) ] [ Designated as safety issue: No ]according to RECIST, including measurable disease patients only, and including patients with CA-125 defined disease as well
- Progression-free survival [ Time Frame: End of Follow-up (up to 1 year) ] [ Designated as safety issue: No ]
- Overall survival [ Time Frame: End of Follow-up (up to 1 year) ] [ Designated as safety issue: No ]
- Translational research [ Time Frame: 3 years ] [ Designated as safety issue: No ]
KRAS,BRAF,PIK3CA,PTEN Patients are tested for the before mentioned gene markers and evaluated in relation to the other outcome variables.
Optional outcome measurement, not necessary for all patients
- 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) ] [ Designated as safety issue: Yes ]
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.
- 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) ] [ Designated as safety issue: No ]according to RECIST, including measurable disease patients only, and including patients with CA-125 defined disease as well
| Estimated Enrollment: | 140 |
| Study Start Date: | October 2011 |
| Estimated Study Completion Date: | July 2015 |
| Estimated Primary Completion Date: | July 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Experimental arm (A):
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. |
Drug: Panitumumab
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.
Other Name: Vectibix
Drug: pegylated liposomal doxorubicin (PLD)
pegylated liposomal doxorubicin (PLD) 30 mg/m² d1 q4w until progressive disease or for a max. of 6 cycles
Other Name: Caelyx
Drug: Carboplatin
Carboplatin AUC 5 d1 q4w until progressive disease or for a max. of 6 cycles
Other Name: multiple generics in existence
Drug: Gemcitabine
gemcitabine 1000 mg/m² d1 + 8 q3w until progressive disease or for a max. of 6 cycles
Other Name: Gemzar
Drug: Carboplatin
Carboplatin AUC 4 d1 q3w until progressive disease or for a max. of 6 cycles
Other Name: multiple generics in existence
Drug: Panitumumab
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.
Other Name: Vectibix
|
|
Active Comparator: Standard arm (B):
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. |
Drug: pegylated liposomal doxorubicin (PLD)
pegylated liposomal doxorubicin (PLD) 30 mg/m² d1 q4w until progressive disease or for a max. of 6 cycles
Other Name: Caelyx
Drug: Carboplatin
Carboplatin AUC 5 d1 q4w until progressive disease or for a max. of 6 cycles
Other Name: multiple generics in existence
Drug: Gemcitabine
gemcitabine 1000 mg/m² d1 + 8 q3w until progressive disease or for a max. of 6 cycles
Other Name: Gemzar
Drug: Carboplatin
Carboplatin AUC 4 d1 q3w until progressive disease or for a max. of 6 cycles
Other Name: multiple generics in existence
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- 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.
- 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.
Exclusion Criteria:
- 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
- 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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01388621
Contacts
| Contact: Nadine Albers | 0351-25933-281 | nadine.albers@gmiho.de |
Locations
| Germany | |
| Praxis Dr. Oettle | Recruiting |
| Friedrichshafen, Baden-Württemberg, Germany, 88045 | |
| Principal Investigator: Helmut Oettle, MD (PD Dr. med.) | |
| Carl-Thiem-Klinikum Cottbus Frauenklinik | Recruiting |
| Cottbus, Brandenburg, Germany, 03048 | |
| Principal Investigator: Andrzej Popiela, MD (Dr. med.) | |
| Praxis Dr. Heinrich | Recruiting |
| Fuerstenwalde, Brandenburg, Germany, 15517 | |
| Principal Investigator: Georg Heinrich, MD (Dr. med.) | |
| Universitätsfrauenklinik am Klinikum Südstadt | Withdrawn |
| Rostock, mecklenburg-Vorpommern, Germany, 18059 | |
| MVM mbH Onkologische Schwerpunktpraxis Leer | Recruiting |
| Leer, Niedersachsen, Germany, 26789 | |
| Principal Investigator: Lothar Müller, MD (Dr. med.) | |
| Medizinisches Zentrum Bonn-Friedensplatz | Recruiting |
| Bonn, Nordrhein-Westfalen, Germany, 53111 | |
| Principal Investigator: Christian M Kurbacher, MD (PD Dr. med.) | |
| Martin-Luther-Universität Halle-Wittenberg Zentrum für Frauenheilkunde und Geburtshilfe | Recruiting |
| Halle, Sachsen-Anhalt, Germany, 06120 | |
| Principal Investigator: Hans-Georg Strauss, MD (Dr. med.) | |
| Klinikum Magdeburg | Recruiting |
| Magdeburg, Sachsen-Anhalt, Germany, 39130 | |
| Principal Investigator: Christoph Kahl, MD (PD Dr. med.) | |
| Klinikum Chemnitz Frauen- und Kinderklinik | Recruiting |
| Chemnitz, Sachsen, Germany, 09116 | |
| Principal Investigator: Petra Krabisch, MD (Dr. med.) | |
| Gynäkologische Praxis Dr. med. Ruhmland | Recruiting |
| Berlin, Germany, 12683 | |
| Principal Investigator: Birgit Ruhmland, MD (Dr.) | |
| Helios Klinikum Berlin - Buch | Withdrawn |
| Berlin, Germany, 13125 | |
| Praxisklinik Frauenheilkunde | Recruiting |
| Berlin, Germany, 10367 | |
| Principal Investigator: Peter Klare, MD (Dr. med.) | |
| Ev. Waldkrankenhaus Spandau | Recruiting |
| Berlin, Germany, 13589 | |
| Principal Investigator: Jochem Potenberg, MD (Dr. med) | |
| Frauenklinik Charité - Universitätsmedizin Berlin Campus Virchow-Klinikum | Recruiting |
| Berlin, Germany, 13353 | |
| Principal Investigator: Jalid Sehouli, MD (Prof. Dr. med.) | |
| Praxis Dr. Schilling / Till / Kohn FÄ f. Gynäkologie u. Geburtshilfe, Gynäkol.-Onkol. Schwerpunktpraxis | Recruiting |
| Berlin, Germany, 10317 | |
| Principal Investigator: Jörg Schilling, MD (Dr.) | |
| Park-Klinik Weißensee | Recruiting |
| Berlin, Germany, 13086 | |
| Principal Investigator: Elke Keil, MD (Dr.) | |
| Tagesklinik Altonaer Strasse | Recruiting |
| Hamburg, Germany, 20357 | |
| Principal Investigator: Andreas Nugent, MD (Dr. med.) | |
Sponsors and Collaborators
WiSP Wissenschaftlicher Service Pharma GmbH
ClinAssess GmbH
Investigators
| Principal Investigator: | Jalid Sehouli, MD (Prof. Dr. med.) | Frauenklinik Charité - Universitätsmedizin Berlin Campus Virchow-Klinikum |
More Information
No publications provided
| Responsible Party: | WiSP Wissenschaftlicher Service Pharma GmbH |
| ClinicalTrials.gov Identifier: | NCT01388621 History of Changes |
| Other Study ID Numbers: | GMIHO-008/2009_AG56, 2010-018849-59 |
| Study First Received: | May 17, 2011 |
| Last Updated: | March 12, 2013 |
| Health Authority: | Germany: Paul-Ehrlich-Institut |
Keywords provided by WiSP Wissenschaftlicher Service Pharma GmbH:
|
ovarian cancer fallopian cancer recurrent platinum-sensitive KRAS-Wildtype |
Additional relevant MeSH terms:
|
Ovarian Neoplasms Endocrine Gland Neoplasms Neoplasms by Site Neoplasms Ovarian Diseases Adnexal Diseases Genital Diseases, Female Genital Neoplasms, Female Urogenital Neoplasms Endocrine System Diseases Gonadal Disorders Doxorubicin Gemcitabine Carboplatin Antibodies, Monoclonal |
Antibiotics, Antineoplastic Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Antimetabolites, Antineoplastic Antimetabolites Molecular Mechanisms of Pharmacological Action Antiviral Agents Anti-Infective Agents Enzyme Inhibitors Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs Radiation-Sensitizing Agents |
ClinicalTrials.gov processed this record on May 22, 2013