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

NCT00861120 | Completed Phase 2 DMC

• 1 other identifier: 2008-007799-13
• Study Type: interventional
• Target: 33
• Locations: 4 countries
• Sites: 6

Brief 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®).

Conditions

Epithelial Ovarian Cancer

Keywords

Ovarian cancer; KRAS wildtype; Platinum resistant

Outcome Measures

Primary Outcomes (1)

• Response rate

  6 months.

Secondary Outcomes (3)

• Progression Free Survival

  6 months.

• Overall survival

  Up to 5 years

• Toxicity

  6 months

Interventions

Pegylated liposomal doxorubicin DRUG

40 mg/m2 on day 1 of a 28 days cycle

Also known as: Caelyx

Panitumumab DRUG

6 mg/kg on days 1 and 15 of a 28 days cycle

Also known as: Vectibix

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Vejle Hospital: lead

Study Sites (6)

AGO Austria

Innsbruck, Austria

Location

Leuven University Hospital

Leuven, Belgium

Location

Aalborg Hospital

Aalborg, Denmark

Location

Herning Regional Hospital

Herning, Denmark

Location

Vejle Hospital, Dept. of Oncology

Vejle, Denmark

Location

Lund University Hospital

Lund, Sweden

Location

MeSH Terms

Conditions

Carcinoma, Ovarian Epithelial; Ovarian Neoplasms

Interventions

liposomal doxorubicin; Panitumumab

Condition Hierarchy (Ancestors)

Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Endocrine Gland Neoplasms; Neoplasms by Site; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Anders Jakobsen, MD, DMSc

  Vejle Hospital

  STUDY CHAIR

• Karina D. Steffensen, MD, PhD

  Vejle Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 12, 2009
• First Posted: March 13, 2009
• Study Start: April 1, 2009
• Primary Completion: August 1, 2011
• Study Completion: August 1, 2012
• Last Updated: October 26, 2012

Record last verified: 2012-10

Locations

SE (1); DK (3); BE (1); AU (1)