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

Epithelial Ovarian Cancer Clinical Trial

— PaLiDo  

Official title:

Panitumumab and Pegylated Liposomal Doxorubicin for Platinum-Resistant Epithelial Ovarian Cancer With Kirsten Rat Sarcoma Viral Oncogene Homolog (KRAS) Wild-type

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00861120
• Other study ID #: 2008-007799-13
• Status: Completed
• Phase: Phase 2
• First received: March 12, 2009
• Last updated: October 25, 2012
• Start date: April 2009
• Est. completion date: August 2012

Study information

• Verified date: October 2012
• Source: Vejle Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Ethics CommitteeDenmark: Danish Medicines AgencyDenmark: Danish Dataprotection Agency
• Study type: Interventional

Clinical Trial Summary

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®).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 33
• Est. completion date: August 2012
• Est. primary completion date: August 2011
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Factorial Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Epithelial Ovarian Cancer
• Neoplasms, Glandular and Epithelial
• Ovarian Neoplasms

Intervention

Drug:
• Pegylated liposomal doxorubicin
40 mg/m2 on day 1 of a 28 days cycle
• Panitumumab
6 mg/kg on days 1 and 15 of a 28 days cycle

Locations

Country	Name	City	State
Austria	AGO Austria	Innsbruck
Belgium	Leuven University Hospital	Leuven
Denmark	Aalborg Hospital	Aalborg
Denmark	Herning Regional Hospital	Herning
Denmark	Vejle Hospital, Dept. of Oncology	Vejle
Sweden	Lund University Hospital	Lund

Sponsors (1)

Lead Sponsor	Collaborator
Vejle Hospital

Countries where clinical trial is conducted

Austria,  Belgium,  Denmark,  Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Response rate		6 months.	No
Secondary	Progression Free Survival		6 months.	No
Secondary	Overall survival		Up to 5 years	No
Secondary	Toxicity		6 months	No