NCT01388621

Brief 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 with platinum-sensitive recurrent ovarian cancer. It is expected that the progression free survival rate at 12 months is improved by the targeted regimen.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
140

participants targeted

Target at P75+ for phase_2 ovarian-cancer

Timeline
Completed

Started Oct 2011

Typical duration for phase_2 ovarian-cancer

Geographic Reach
1 country

18 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 17, 2011

Completed
2 months until next milestone

First Posted

Study publicly available on registry

July 6, 2011

Completed
3 months until next milestone

Study Start

First participant enrolled

October 1, 2011

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2014

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2015

Completed
Last Updated

August 20, 2013

Status Verified

August 1, 2013

Enrollment Period

2.8 years

First QC Date

May 17, 2011

Last Update Submit

August 19, 2013

Conditions

Ovarian Cancer

Keywords

ovarian cancerfallopian cancerrecurrentplatinum-sensitiveKRAS-Wildtype

Outcome Measures

Primary Outcomes (1)

  • 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).

    12 month

Secondary Outcomes (5)

  • Duration of Tumor-Response

    Duration of Therapy (Therapy is planned for 6 cycles of 3 resp. 4 weeks each, shorter or longer durations are possible)

  • Progression-free survival

    End of Follow-up (up to 1 year)

  • Overall survival

    End of Follow-up (up to 1 year)

  • Maximum toxicity resp. AE grade per patient per toxicity resp. AE during therapy

    Duration of Therapy (Therapy is planned for 6 cycles of 3 resp. 4 weeks each, shorter or longer durations are possible)

  • Tumor Response Rate

    Duration of Therapy (Therapy is planned for 6 cycles of 3 resp. 4 weeks each, shorter or longer durations are possible)

Study Arms (2)

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.

Drug: PanitumumabDrug: pegylated liposomal doxorubicin (PLD)Drug: CarboplatinDrug: 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.

Drug: pegylated liposomal doxorubicin (PLD)Drug: CarboplatinDrug: Gemcitabine

Interventions

PanitumumabDRUG

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.

Also known as: Vectibix
Experimental arm (A):
pegylated liposomal doxorubicin (PLD)DRUG

pegylated liposomal doxorubicin (PLD) 30 mg/m² d1 q4w until progressive disease or for a max. of 6 cycles

Also known as: Caelyx
Experimental arm (A):Standard arm (B):
CarboplatinDRUG

Carboplatin AUC 5 d1 q4w until progressive disease or for a max. of 6 cycles

Also known as: multiple generics in existence
Experimental arm (A):Standard arm (B):
GemcitabineDRUG

gemcitabine 1000 mg/m² d1 + 8 q3w until progressive disease or for a max. of 6 cycles

Also known as: Gemzar
Experimental arm (A):Standard arm (B):

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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 \[Patients who are being therapeutically anticoagulated with an agent such as coumarin or heparin will be allowed to participate provided that no prior evidence of underlying abnormality in these parameters exists.\]
  • +3 more criteria

You may not qualify if:

  • 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.
  • +6 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (18)

Praxis Dr. Oettle

Friedrichshafen, Baden-Wurttemberg, 88045, Germany

RECRUITING

Stauferklinikum Schwäbisch Gmünd

Mutlangen, Baden-Wurttemberg, 73557, Germany

RECRUITING

Carl-Thiem-Klinikum Cottbus Frauenklinik

Cottbus, Brandenburg, 03048, Germany

RECRUITING

Praxis Dr. Heinrich

Fürstenwalde, Brandenburg, 15517, Germany

RECRUITING

Tagesklinik Altonaer Strasse

Hamburg, Hamburg, 20357, Germany

RECRUITING

MVM mbH Onkologische Schwerpunktpraxis Leer

Leer, Lower Saxony, 26789, Germany

RECRUITING

Universitätsfrauenklinik am Klinikum Südstadt

Rostock, Mecklenburg-Vorpommern, 18059, Germany

WITHDRAWN

Medizinisches Zentrum Bonn-Friedensplatz

Bonn, North Rhine-Westphalia, 53111, Germany

RECRUITING

Klinikum Chemnitz Frauen- und Kinderklinik

Chemnitz, Saxony, 09116, Germany

RECRUITING

Martin-Luther-Universität Halle-Wittenberg Zentrum für Frauenheilkunde und Geburtshilfe

Halle, Saxony-Anhalt, 06120, Germany

RECRUITING

Klinikum Magdeburg

Magdeburg, Saxony-Anhalt, 39130, Germany

RECRUITING

Praxisklinik Frauenheilkunde

Berlin, State of Berlin, 10367, Germany

RECRUITING

Helios Klinikum Berlin - Buch

Berlin, State of Berlin, 13125, Germany

WITHDRAWN

Frauenklinik Charité - Universitätsmedizin Berlin Campus Virchow-Klinikum

Berlin, State of Berlin, 13353, Germany

RECRUITING

Ev. Waldkrankenhaus Spandau

Berlin, State of Berlin, 13589, Germany

RECRUITING

Praxis Dr. Schilling / Till / Kohn FÄ f. Gynäkologie u. Geburtshilfe, Gynäkol.-Onkol. Schwerpunktpraxis

Berlin, 10317, Germany

RECRUITING

Gynäkologische Praxis Dr. med. Ruhmland

Berlin, 12683, Germany

RECRUITING

Park-Klinik Weißensee

Berlin, 13086, Germany

RECRUITING

MeSH Terms

Conditions

Ovarian NeoplasmsRecurrence

Interventions

Panitumumabliposomal doxorubicinCarboplatinGemcitabine

Condition Hierarchy (Ancestors)

Endocrine Gland NeoplasmsNeoplasms by SiteNeoplasmsOvarian DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Neoplasms, FemaleUrogenital NeoplasmsGenital DiseasesEndocrine System DiseasesGonadal DisordersDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, HumanizedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulinsCoordination ComplexesOrganic ChemicalsHeterocyclic CompoundsDeoxycytidineCytidinePyrimidine NucleosidesPyrimidinesHeterocyclic Compounds, 1-Ring

Study Officials

  • Jalid Sehouli, MD (Prof. Dr. med.)

    Frauenklinik Charité - Universitätsmedizin Berlin Campus Virchow-Klinikum

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Nadine Albers

CONTACT

0351-25933-281nadine.albers@gmiho.de

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 17, 2011

First Posted

July 6, 2011

Study Start

October 1, 2011

Primary Completion

July 1, 2014

Study Completion

July 1, 2015

Last Updated

August 20, 2013

Record last verified: 2013-08

Locations

DE(18)