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Sponsored by: |
Vejle Hospital |
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Information provided by: | Vejle Hospital |
ClinicalTrials.gov Identifier: | NCT00861120 |
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 |
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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 |
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) |
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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
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
Adequate bone marrow function, liver function, renal function and coagulation parameters (within 7 days prior to randomization):
Exclusion Criteria:
Clinically significant cardiovascular disease ≤ 1 year before enrollment/randomization, including:
Contact: Anders Jakobsen, Professor | anders.jakobsen@slb.regionsyddanmark.dk | |
Contact: Karina D. Steffensen, MD, PhD | karina.dahl.steffensen@slb.regionsyddanmark.dk |
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 |
Study Chair: | Anders Jakobsen, Professor | Vejle Hospital |
Principal Investigator: | Karina D. Steffensen, MD, PhD | Vejle Hospital |
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 |
KRAS wildtype |
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 |
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 |