Panitumumab and Gemcitabine in Relapsed Ovarian Cancer

NCT01296035 | Terminated Phase 2 Results DMC

• 1 other identifier: WIH 20050782
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

Brief Summary

This is a study to find out if the study drug, panitumumab, when given with gemcitabine works in treating ovarian cancer and to find out what side effects occur when they are given together.

Conditions

Ovarian Cancer; Fallopian Tube Cancer; Primary Peritoneal Cancer

Keywords

recurrent ovarian cancer; platinum-refractory ovarian cancer

Outcome Measures

Primary Outcomes (1)

• Overall Response Rate, Measured by RECIST Criteria

  Documentation of known measurable or evaluable disease parameters after every 2 cycles of treatment. If any patient is withdrawn for the study prior to completion of therapy a repeat evaluation will be done at that time.

  Every 8 weeks while on-study

Secondary Outcomes (1)

• Adverse Events, Measured by Active Version of the NCI Common Toxicity Criteria

  Every 4 weeks while on-study, up to 24 weeks

Study Arms (1)

Panitumumab and Gemcitabine

EXPERIMENTAL

Panitumumab and Gemcitabine

Biological: Panitumumab

Interventions

Panitumumab BIOLOGICAL

Panitumumab 2.5 mg/kg on D1, D8, D15, and D22 and Gemcitabine 800 mg/m2 on D1, D8, and D15 of each 28 day cycle.

Panitumumab and Gemcitabine

Eligibility Criteria

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

You may qualify if:

• Histologically or cytologically confirmed diagnosis of metastatic, advanced, or recurrent platinum-resistant epithelial ovarian, primary peritoneal or fallopian tube cancer.
• Prior first line therapy with a platinum and taxane based combination as adjuvant therapy
• Measurable disease defined by RECIST criteria
• Voluntary written informed consent before performance of any study-related procedure not part of normal medical care, with the understanding that consent may be withdrawn by the subject at any time without prejudice to future medical care.
• Female subject is either post-menopausal or surgically sterilized or willing to use an acceptable method of birth control (i.e., a hormonal contraceptive, intra-uterine device, diaphragm with spermicide, condom with spermicide, or abstinence) for the duration of the study.
• age \> 18
• Karnofsky performance status \> 70
• Up to three prior lines of cytotoxic therapy in the setting of recurrent disease.
• Estimated life expectancy of at least 3 months
• Women of child-bearing potential must have a negative pregnancy test
• Adequate hematopoietic function defined as:
• ANC ≥ 1500/mm3
• Platelets ≥ 100,000/mm3
• Hemoglobin ≥ 9 g/dL
• Magnesium ≥ lower limit of normal

You may not qualify if:

• Prior anti-EGFr antibody therapy (e.g., cetuximab) or treatment with small molecule EGFr inhibitors (e.g., gefitinib, erlotinib, lapatinib)
• Prior treatment with gemcitabine
• Radiotherapy ≤ 14 days prior to enrollment.
• More than three lines of systemic chemotherapy for recurrent or advanced disease. Prior hormonal therapy is allowed.
• Prior immunotherapy, or experimental or approved proteins/antibodies
• Female subject is pregnant or breast-feeding.
• Patient has received other investigational drugs within 28 days before enrollment
• Serious medical or psychiatric illness likely to interfere with participation in this clinical study.
• Prior treatment with panitumumab
• Concurrent uncontrolled illness
• Ongoing or active infection
• History or active secondary cancer within the last 5 years, except for superficial basal cell skin cancers, curatively resected non-melanoma skin cancer
• Psychiatric illness or social situation that would preclude study compliance.
• History or known presence of central nervous system (CNS) metastasis
• Subjects requiring chronic use of immunosuppressive agents (e.g., methotrexate, cyclosporine)

Sponsors & Collaborators

• Women and Infants Hospital of Rhode Island: lead
• Amgen: collaborator

Study Sites (1)

Women & Infants' Hospital

Providence, Rhode Island, 02905, United States

Location

MeSH Terms

Conditions

Ovarian Neoplasms; Fallopian Tube Neoplasms

Interventions

Panitumumab

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; 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; Fallopian Tube Diseases

Intervention Hierarchy (Ancestors)

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

Limitations and Caveats

This study was terminated prematurely due to poor accrual. The outcome measures could not be analyzed due to the small number or participants.

Results Point of Contact

• Title: Director of Clinical Trials
• Organization: Women & Infants Hospital

jmari@wihri.org

401-274-1122

Study Officials

• Carolyn McCourt, MD

  Women & Infants' Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr. Carolyn McCourt

Study Record Dates

• First Submitted: February 9, 2011
• First Posted: February 15, 2011
• Study Start: February 1, 2011
• Primary Completion: October 1, 2013
• Study Completion: November 1, 2013
• Last Updated: August 25, 2015
• Results First Posted: August 25, 2015

Record last verified: 2015-07

Locations

US (1)