Safety and Efficacy Study of Gemcitabine Plus Bevacizumab in Patients With Platinum-Resistant Ovarian, Primary Peritoneal or Fallopian Tube Cancer

NCT01131039 | Withdrawn Phase 2 DMC

• 2 other identifiers: IRB00023366AVF4314S
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of the study is to determine whether the administration of bevacizumab and gemcitabine given by IV infusion can prolong survival, delay tumor growth, and/or shrink tumors in patients with ovarian cancer, primary peritoneal, or fallopian tube cancer.

Conditions

Fallopian Tube Neoplasms; Ovarian Cancer; Primary Peritoneal

Keywords

Ovarian Cancer

Outcome Measures

Primary Outcomes (1)

• Progression-free survival

  The primary outcome measure is progression-free survival. Disease status and response rates will be determined by investigator assessment using RECIST or CA-125 changes (subjects with nonmeasurable disease only)

  2 years

Secondary Outcomes (1)

• Safety and tolerability of bevacizumab in combination with gemcitabine will be assessed.

  2 years

Study Arms (1)

Single

EXPERIMENTAL

Drug: Gemcitabine/Bevacizumab

Interventions

Gemcitabine/Bevacizumab DRUG

Gemcitabine: IV, days 1,8, and every 21 days Bevacizumab: IV, day 1 and every 21 days until disease progression

Also known as: Gemcitabine, Gemzar®, Bevacizumab, Avastin

Single

Eligibility Criteria

• Age: 19 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients must have platinum-resistant ovarian, primary peritoneal or fallopian tube cancer.
• Patients will be included in the study based on the following criteria:
• Signed informed consent
• Age ≥ 19 yrs
• Advanced, histologically documented ovarian, primary peritoneal, or fallopian tube cancer
• Measurable disease with at least one lesion that can be accurately measured in at least one dimension (longest dimension recorded). Each lesion must be \> 20 mm when measured by conventional techniques, including palpation, plain x-ray, CT and MRI, or \> 10 mm when measured by spiral CT. OR Clinically or radiologically detectable disease (ascites, peritoneal deposits, mesenteric thickening or lesions that do not fulfill RECIST for measurable disease). In addition, the subject must have two consecutive rising pretreatment CA-125 levels that are both \> 2x the institutional upper limit of normal (ULN) and 40.0 IU/ml taken at least 1 week and nor more than 3 months apart.
• Platinum-resistant or refractory cancer; subjects must not have had a biologic or chemotherapeutic regimen for treatment of platinum-resistant disease prior to study entry. Subjects with primary platinum-resistant cancer must have had a tumor recurrence within 6 months after completing or while receiving a platinum-containing regimen. These subjects must not have had any other non-platinum-containing regimen. OR Subjects with secondary platinum-resistant cancer may have had any regimen with any response and then have had tumor recurrence within 6 months after completing or while receiving retreatment with a platinum-containing regimen. These subjects must have received only two prior chemotherapeutic regimens. OR Subjects who receive a chemotherapeutic regimen as consolidation after a response to a platinum-containing regimen must have had tumor recurrence within 6 months after completing or while receiving the consolidation regimen.
• Life expectancy \> 12 weeks
• ECOG performance status 0 or 1
• Use of an effective means of contraception (for women of childbearing potential)
• Clinical laboratory test results: Granulocyte count \> 1500/µL; Platelet count \> 75000/µL; Hemoglobin \> 9g/dL (hemoglobin may be supported by transfusion or erythropoietin or other approved hematopoietic growth factors; darbepoetin is permitted); Serum bilirubin \< 1.5 the ULN; alkaline phosphatase, AST, and ALT \< 2.5 ULN ( AST, ALT \< 5.0 ULN for subjects with liver metastasis); Serum creatinine \< 1.5 ULN; International normalized ratio (INR) \< 1.5 and activated partial thromboplastin time (aPTT) \< 1.5 ULN (except for subjects receiving anti-coagulation therapy)

You may not qualify if:

• Prior treatment with gemcitabine
• Three or more prior chemotherapeutic regimens for the management of primary disease
• Prior treatment with experimental anti-cancer agents within 4 weeks prior to Day 1 (the day the first study treatment infusions are administered)
• History or clinical evidence of central nervous system or brain metastases
• Prior treatment with Avastin or other anti-angiogenic agent
• Uncontrolled hypercalcemia ( \>11.5 mg/dL)
• History of other malignancies within 5 years of Day 1, except for adequately treated carcinoma in situ of the cervix, ductal carcinoma in situ (DCIS) of breast, basal or squamous cell skin cancer
• History of serious systemic disease, unstable angina, myocardial infarction, stroke, transient ischemic attack,, symptoms of CHF, or unstable symptomatic arrhythmia requiring medication (subjects with chronic atrial arrhythmia, i.e., atrial fibrillation, paroxysmal supraventricular tachycardia, are eligible) within 6 months prior to Day 1 of treatment
• Known HIV infection
• Pregnancy or lactation
• Major surgery, open biopsy, or significant traumatic injury within 4 weeks prior to Day 1 of treatment, or anticipation of need for major surgical procedure during the course of the study
• Inability to comply with study and follow-up procedures
• Any other diseases, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug or that may affect the interpretation of the results or render the subject at high risk from treatment complications
• Life expectancy of less than 12 weeks
• Current, recent (within 4 weeks of the first infusion of this study), or planned participation in an experimental drug study other than a Genentech-sponsored bevacizumab cancer study

Sponsors & Collaborators

• Emory University: lead
• Genentech, Inc.: collaborator

MeSH Terms

Conditions

Fallopian Tube Neoplasms; Ovarian Neoplasms

Interventions

Gemcitabine; Bevacizumab

Condition Hierarchy (Ancestors)

Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Fallopian Tube Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Endocrine Gland Neoplasms; Ovarian Diseases; Endocrine System Diseases; Gonadal Disorders

Intervention Hierarchy (Ancestors)

Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Sharmila Makhija, MD

  Emory University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 21, 2010
• First Posted: May 26, 2010
• Study Start: January 1, 2011
• Primary Completion: September 1, 2011
• Study Completion: September 1, 2011
• Last Updated: December 20, 2013

Record last verified: 2013-12