Panitumumab and Pegylated Liposomal Doxorubicin for Platinum-Resistant Epithelial Ovarian Cancer With KRAS Wild-type (PaLiDo)

October 25, 2012 updated by: Vejle Hospital

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®).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

33

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Austria
      • Innsbruck, Austria
        • AGO Austria
  • Belgium
      • Leuven, Belgium
        • Leuven University Hospital
  • Denmark
      • Aalborg, Denmark
        • Aalborg Hospital
      • Herning, Denmark
        • Herning Regional Hospital
      • Vejle, Denmark
        • Vejle Hospital, Dept. of Oncology
  • Sweden
      • Lund, Sweden
        • Lund University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Factorial Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Response rate
Time Frame: 6 months.
6 months.

Secondary Outcome Measures

Outcome Measure
Time Frame
Overall survival
Time Frame: Up to 5 years
Up to 5 years
Progression Free Survival
Time Frame: 6 months.
6 months.
Toxicity
Time Frame: 6 months
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Vejle Hospital

Investigators

  • Study Chair: Anders Jakobsen, MD, DMSc, Vejle Hospital
  • Principal Investigator: Karina D. Steffensen, MD, PhD, Vejle Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2009

Primary Completion (Actual)

August 1, 2011

Study Completion (Actual)

August 1, 2012

Study Registration Dates

First Submitted

March 12, 2009

First Submitted That Met QC Criteria

March 12, 2009

First Posted (Estimate)

March 13, 2009

Study Record Updates

Last Update Posted (Estimate)

October 26, 2012

Last Update Submitted That Met QC Criteria

October 25, 2012

Last Verified

October 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2008-007799-13

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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