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Panitumumab and Pegylated Liposomal Doxorubicin for Platinum-Resistant Epithelial Ovarian Cancer With Kirsten Rat Sarcoma Viral Oncogene Homolog (KRAS) Wild-Type
This study is currently recruiting participants.
Verified by Vejle Hospital, May 2009
First Received: March 12, 2009   Last Updated: May 5, 2009   History of Changes
Sponsored by: Vejle Hospital
Information provided by: Vejle Hospital
ClinicalTrials.gov Identifier: NCT00861120
  Purpose

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®).


Condition Intervention Phase
Epithelial Ovarian Cancer
Drug: Pegylated liposomal doxorubicin
Drug: Panitumumab
Phase II

Study Type: Interventional
Study Design: Treatment, Safety/Efficacy Study
Official Title: Panitumumab and Pegylated Liposomal Doxorubicin for Platinum-Resistant Epithelial Ovarian Cancer With KRAS Wild-Type

Resource links provided by NLM:


Further study details as provided by Vejle Hospital:

Primary Outcome Measures:
  • Response rate

Secondary Outcome Measures:
  • Progression Free Survival
  • Overall survival
  • Toxicity
  • Translational research including biomarkers expressed in tumor tissue and blood and their potential predictive or prognostic value

Estimated Enrollment: 33
Study Start Date: April 2009
Estimated Study Completion Date: August 2010
Estimated Primary Completion Date: January 2010 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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.
  • 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

Exclusion Criteria:

  • 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
  • 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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00861120

Contacts
Contact: Anders Jakobsen, Professor anders.jakobsen@slb.regionsyddanmark.dk
Contact: Karina D. Steffensen, MD, PhD karina.dahl.steffensen@slb.regionsyddanmark.dk

Locations
Denmark
Vejle Hospital, Dept. of Oncology Recruiting
Vejle, Denmark
Contact: Karina D. Steffensen, MD, PhD         karina.dahl.steffensen@slb.regionsyddanmark.dk    
Principal Investigator: Karina D. Steffensen, MD, Phd            
Sub-Investigator: Anders Jakobsen, Prof., DMSc            
Herning Regional Hospital Not yet recruiting
Herning, Denmark
Contact: Nina Keldsen, MD            
Principal Investigator: Nina Keldsen, MD            
Aalborg Hospital Not yet recruiting
Aalborg, Denmark
Contact: Bente Lund, MD            
Principal Investigator: Bente Lund, MD            
Sponsors and Collaborators
Vejle Hospital
Investigators
Study Chair: Anders Jakobsen, Professor Vejle Hospital
Principal Investigator: Karina D. Steffensen, MD, PhD Vejle Hospital
  More Information

No publications provided

Responsible Party: ( Professor, MD, DMSc Anders Jakobsen )
Study ID Numbers: 2008-007799-13
Study First Received: March 12, 2009
Last Updated: May 5, 2009
ClinicalTrials.gov Identifier: NCT00861120     History of Changes
Health Authority: Denmark: Ethics Committee;   Denmark: Danish Medicines Agency;   Denmark: Danish Dataprotection Agency

Keywords provided by Vejle Hospital:
KRAS wildtype

Study placed in the following topic categories:
Ovarian Neoplasms
Gonadal Disorders
Genital Neoplasms, Female
Endocrine System Diseases
Urogenital Neoplasms
Ovarian Diseases
Ovarian Epithelial Cancer
Doxorubicin
Genital Diseases, Female
Anti-Bacterial Agents
Malignant Mesenchymal Tumor
Soft Tissue Sarcomas
Sarcoma
Ovarian Cancer
Endocrinopathy
Endocrine Gland Neoplasms

Additional relevant MeSH terms:
Ovarian Neoplasms
Antineoplastic Agents
Gonadal Disorders
Genital Neoplasms, Female
Endocrine System Diseases
Urogenital Neoplasms
Ovarian Diseases
Antibiotics, Antineoplastic
Pharmacologic Actions
Doxorubicin
Adnexal Diseases
Genital Diseases, Female
Neoplasms
Neoplasms by Site
Therapeutic Uses
Endocrine Gland Neoplasms

ClinicalTrials.gov processed this record on September 10, 2009