Avastin in Combination Wtih Docetaxel in Ovarian/Fallopian Tube/Peritoneum Carcinoma

This study has been completed.
Sponsor:
Collaborators:
Genentech
Sanofi
Information provided by (Responsible Party):
H. Lee Moffitt Cancer Center and Research Institute
ClinicalTrials.gov Identifier:
NCT00504257
First received: July 17, 2007
Last updated: December 6, 2012
Last verified: December 2012
  Purpose

The purpose of this study is to evaluate the effectiveness of the combination of Avastin and Docetaxel in the treatment of women with platinum sensitive recurrent epithelial ovarian cancer within 12 months of platinum chemotherapy.


Condition Intervention Phase
Fallopian Tube Cancer
Ovarian Cancer
Malignant Tumor of Peritoneum
Drug: Avastin
Drug: Docetaxel
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase II Trial of Avastin in Combination With Docetaxel in Patients With Recurrence of Epithelial Carcinoma of the Ovary/Fallopian Tube/Peritoneum Within 12 Months of Platinum Therapy

Resource links provided by NLM:


Further study details as provided by H. Lee Moffitt Cancer Center and Research Institute:

Primary Outcome Measures:
  • Progression-free Survival (PFS) at 6 Months [ Time Frame: 6 months per participant ] [ Designated as safety issue: No ]
    Progression-Free Survival (PFS): is the period from study entry until disease progression, death due to disease progression or date of last contact. Progressive Disease (PD): At least a 20% increase in the sum of the longest diameter (LD) of target lesions, taking as reference the smallest sum LD recorded since the treatment started, progression of non-target lesions, or the appearance of one or more new lesions.


Secondary Outcome Measures:
  • Duration of PFS [ Time Frame: 5 years ] [ Designated as safety issue: No ]

    Duration of Response: Time in months of stable disease, complete response or partial response to progressive disease. Stable Disease: Any condition not meeting the other RECIST criteria (CR, PR, PD, Symptomatic Deterioration).

    Complete Response (CR): Disappearance of all target and non-target lesions and no evidence of new lesions is documented by 2 disease assessments at least 4 weeks apart. Normalization of CA-125 level, if elevated at baseline.


  • Response Rate (RR) [ Time Frame: 5 years ] [ Designated as safety issue: No ]

    Partial Response (PR): At least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum longest diameter (LD). There can be no unequivocal progression of nontarget lesions and no new lesions. Documented by 2 disease assessments at least 4 weeks apart is required. In the case where the ONLY target lesion is a solitary pelvic mass measured only by physical exam, which is not radiographically measurable, a 50% decrease in the LD is required. A PR according to CA-125 levels has occurred if a 50% decrease in the level from the 2 elevated baseline levels, and must be confirmed by a 4th sample at least 28 days after the prior sample OR a 75% serial decrease in CA-125 levels occurs over 3 samples. Final sample must be analyzed at least 28 days after the prior sample.

    Symptomatic Deterioration: A global deterioration in health status attributable to the disease requiring a change in therapy without objective evidence of PD.


  • Incidence of Serious Adverse Events (SAEs) [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]
    The final safety analysis will include all patients who receive at least one dose of any study drug. The incidence of serious adverse experiences (SAEs) treatment related will be summarized by type and severity and exact 95% confidence intervals (CIs) for the rates of such SAEs will be computed.

  • Overall Survival (OS) [ Time Frame: 5 years ] [ Designated as safety issue: No ]
    Overall Survival (OS): defined as observed length of life from entry onto the protocol to death, or for living patients, date of last contact (regardless of whether or not this contact is on a subsequent protocol). Survival (PFS and OS) will be analyzed using the Kaplan-Meier method with standard errors based on Greenwood's formula.


Enrollment: 45
Study Start Date: March 2007
Study Completion Date: October 2012
Primary Completion Date: October 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Combination Therapy
Immunotherapy (Avastin) and Chemotherapy (Docetaxel) as outlined in Intervention descriptions. Response assessment every 3 cycles (9 weeks).
Drug: Avastin
15 mg/kg, In 100 ml NS IV infusion over 90 +/- 15 minutes, Day 1, every 21 day cycle
Other Names:
  • Avastin™
  • bevacizumab
Drug: Docetaxel
40 mg/m^2, In 250 ml D5W or NS IV infusion over 1 hour in a non-pvc container and through a polyethylene-lined set, Day 1, 8, every 21 day cycle
Other Name: TAXOTERE®

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Signed informed consent
  • Pathologically confirmed epithelial ovarian cancer, peritoneal serous cancer, or fallopian tube cancer
  • Patient's disease recurrence or progression occurs between 0 to 12 months (1 to 365 days) from prior platinum-containing chemotherapy regimen. Patients, however, may not receive study drug until at least 28 days from prior chemotherapy.
  • The patient may have received up to three prior chemotherapy regimens for the treatment of this malignancy. Patients who may have received prior treatment with paclitaxel and/or a platinum compound will be allowed. Rechallenge with the same platinum based regimen is considered 1 prior regimen. Patients who have been treated with consolidation treatment are allowed and the consolidation will not be considered a separate regimen. Hormonal therapy (i.e. progesterones, estrogens, anti-estrogens, aromatase inhibitors) will not be considered a prior chemotherapy regimen.
  • Measurable or evaluable disease either by the Gynecologic Oncology Group (GOG) Response Evaluation Criteria in Solid Tumors (RECIST) or CA 125 criteria (Journal of the National Cancer Institute, Vol. 96, No. 6, March 17, 2004, Vergote JNCI 2000)
  • At least 4 weeks since major surgery, with full recovery
  • At least 3 weeks since radiotherapy, with full recovery. The measurable disease must be completely outside of the radiation port.
  • Eastern Cooperative Oncology Group (ECOG) performance status </= 2
  • Hematologic (minimal values): Absolute neutrophil count >/= 1,500/mm^3, Hemoglobin >/= 8.0 g/dL (transfusions allowed), Platelet count >/= 100,000/mm^3
  • Hepatic: Total Bilirubin </= upper limit of normal (ULN), alanine transaminase (AST) and alanine transaminase (ALT) and alkaline phosphatase must be within the range allowing for eligibility. In determining eligibility the more abnormal of the 2 values (AST or ALT) should be used.
  • Women of childbearing potential must have a negative pregnancy test.
  • Patients of childbearing potential must be willing to consent to using effective contraception while on treatment and for 3 months following the completion of treatment.

Exclusion Criteria:

Prior treatment with Docetaxel or Avastin

  • Concurrent immunotherapy or hormonal therapy for the specific purpose of treatment for the ovarian cancer. Any hormonal therapy directed at the malignant tumor must be discontinued at least one week prior to enrollment in order for the patient to be eligible to participate in this trial. Continuation of hormonal replacement therapy is allowed.
  • Peripheral neuropathy >/= grade 2
  • History of a severe hypersensitivity reaction to Docetaxel, Avastin, or to other drugs formulated with polysorbate (Tween) 80.
  • Current, recent (within 4 weeks of the first infusion of this study), or planned participation in an experimental drug study of Avastin
  • Blood pressure of >150/100 mmHg Unstable angina
  • New York Heart Association (NYHA) Grade II or greater congestive heart failure
  • History of myocardial infarction within 6 months prior to Day 1
  • History of stroke within 6 months prior to Day 1
  • Clinically significant peripheral vascular disease
  • Evidence of bleeding diathesis or coagulopathy
  • Presence of central nervous system or brain metastases
  • Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to Day 0, anticipation of need for major surgical procedure during the course of the study
  • Minor surgical procedures such as fine needle aspirations or core biopsies within 7 days prior to Day 0
  • Pregnant (positive pregnancy test) or lactating
  • Urine protein: creatinine ratio >/= 1.0 at screening
  • History of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 6 months prior to Day 0
  • Serious, non-healing wound, active ulcer, or untreated bone fracture
  • Evidence of malignancy in the last 5 years, other than nonmelanoma cutaneous carcinomas
  • History of hemoptysis (bright red blood of 1/2 teaspoon or more) within last 3 months
  • Patients believed to possibly be at higher than average risk of perforation will be excluded from study. This includes symptoms or findings of partial or complete bowel obstruction, history of fistula, patients requiring parenteral nutrition and hydration, and those with history of prior perforation due to tumor or perforation within last 6 months from other causes.
  • Inability to comply with study and/or follow-up procedures.
  • Patients who are not on a stable dose of anticoagulation therapy. Patients who are on a stable anticoagulation regimen, including coumadin or low molecular-weight heparin, will not be excluded.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00504257

Locations
United States, Florida
Broward General Medical Center Cancer Center
Fort Lauderdale, Florida, United States, 33316
Women's Cancer Associates
Saint Petersburg, Florida, United States, 33701
H. Lee Moffitt Cancer Center and Research Institute
Tampa, Florida, United States, 33612-9497
United States, North Carolina
Duke Cancer Institute
Durham, North Carolina, United States, 27710
Sponsors and Collaborators
H. Lee Moffitt Cancer Center and Research Institute
Genentech
Sanofi
Investigators
Principal Investigator: Robert M. Wenham, MD H. Lee Moffitt Cancer Center and Research Institute
  More Information

Additional Information:
No publications provided

Responsible Party: H. Lee Moffitt Cancer Center and Research Institute
ClinicalTrials.gov Identifier: NCT00504257     History of Changes
Other Study ID Numbers: MCC-14920, AVF3823s, IST13070
Study First Received: July 17, 2007
Last Updated: December 6, 2012
Health Authority: United States: Federal Government
United States: Institutional Review Board

Keywords provided by H. Lee Moffitt Cancer Center and Research Institute:
recurrent ovarian epithelial cancer
recurrent primary peritoneal cavity cancer
recurrent fallopian tube cancer

Additional relevant MeSH terms:
Neoplasms
Carcinoma
Ovarian Neoplasms
Peritoneal Neoplasms
Fallopian Tube Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Endocrine Gland Neoplasms
Neoplasms by Site
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders
Abdominal Neoplasms
Digestive System Neoplasms
Digestive System Diseases
Peritoneal Diseases
Fallopian Tube Diseases
Docetaxel
Bevacizumab
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on May 19, 2013