Bevacizumab and Paclitaxel for Neuroendocrine Tumors of the Cervix

This study has been terminated.
(Due to slow accrual.)
Sponsor:
Collaborator:
Genentech, Inc.
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT00626561
First received: February 20, 2008
Last updated: June 5, 2014
Last verified: June 2014
  Purpose

Objectives:

Primary:

To estimate the efficacy of bevacizumab and paclitaxel in patients with recurrent small cell, large cell, and neuroendocrine cervical and uterine cancers, as measured by progression-free survival.

Secondary:

  1. To estimate the efficacy of bevacizumab and paclitaxel in patients with recurrent small cell, large cell, and neuroendocrine cervical and uterine cancers, as measured by overall survival.
  2. To determine the response rates in patients with recurrent small cell, large cell, and neuroendocrine cervical and uterine cancers when treated with bevacizumab and paclitaxel.
  3. To characterize the quality of life (QoL) in patients with recurrent small cell, large cell, and neuroendocrine cervical and uterine cancers when treated with bevacizumab and paclitaxel.
  4. To determine the nature and degree of toxicity in patients with advanced or recurrent small cell, large cell, or neuroendocrine cervical and uterine cancers when treated with bevacizumab and paclitaxel.

Condition Intervention Phase
Cervical Cancer
Uterine Cancer
Drug: Bevacizumab
Drug: Paclitaxel
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 Evaluation of Bevacizumab and Paclitaxel in Patients With Recurrent Small Cell, Large Cell, and Neuroendocrine Tumors of the Cervix and Uterus

Resource links provided by NLM:


Further study details as provided by M.D. Anderson Cancer Center:

Primary Outcome Measures:
  • Progression-free Survival (PFS) [ Time Frame: Baseline to 6 Months, or until disease progression. ] [ Designated as safety issue: No ]
    Progression-Free Survival is the period from study entry until disease progression, death or date of last contact.


Enrollment: 4
Study Start Date: February 2008
Study Completion Date: July 2011
Primary Completion Date: July 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Bevacizumab + Paclitaxel
Bevacizumab 10 mg/kg intravenous (IV) twice weekly and Paclitaxel 60 mg/m^2 IV weekly.
Drug: Bevacizumab
10 mg/kg IV twice weekly on days 1 and 15.
Other Names:
  • Avastin
  • Anti-VEGF monoclonal antibody
  • rhuMAb-VEGF
Drug: Paclitaxel
60 mg/m^2 IV weekly on days 1, 8, 15, and 22.
Other Name: Taxol

  Show Detailed Description

  Eligibility

Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Patients with histologically confirmed, advanced stage (stage IVB), recurrent, or persistent small cell, large cell, or neuroendocrine tumor of the uterine corpus and cervix
  2. All patients must have measurable disease. Measurable disease is defined as at least one lesion that can be accurately measured in at least one dimension (longest dimension to be 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. Biopsy confirmation is required if the lesion measures < 30 mm or if the treating physician determines it is clinically indicated.
  3. Patients must have at least one "target lesion" to be used to assess response on this protocol as defined by Response Evaluation Criteria in Solid Tumors (RECIST). Tumors within a previously irradiated field will be designated as "non-target" lesions unless progression is documented or a biopsy is obtained to confirm persistence at least 90 days following completion of radiation therapy.
  4. Patients must have adequate: BONE MARROW FUNCTION: Absolute neutrophil count (ANC) greater than or equal to 1,500/mcl and platelets greater than or equal to 100,000/mcl. RENAL FUNCTION: Creatinine less than or equal to 1.5 * institutional upper limit normal (ULN), and measured or estimated creatinine clearance greater than or equal to 50 ml/min. For the purpose of estimating the creatinine clearance, the formula of Jelliffe should be utilized. HEPATIC FUNCTION: Bilirubin less than or equal to 1.5 * ULN. serum glutamate oxaloacetate transaminase (SGOT) and alkaline phosphatase less than or equal to 2.5 * ULN
  5. Patients must have adequate: BLOOD COAGULATION PARAMETERS: prothrombin time (PT) such that international normalized ratio (INR) is < / = 1.5 (or an in-range INR, usually between 2 and 3, if a patient is on a stable dose of therapeutic warfarin) and a partial thromboplastin time (PTT) < 1.2 times the upper limit of normal. NEUROLOGIC FUNCTION: Neuropathy (sensory and motor) less than or equal to [1] Common Toxicity Criteria for Adverse Effects (CTCAE) grade 1.
  6. Patients must have signed an approved informed consent and authorization permitting release of personal health information.
  7. Patients with Eastern Cooperative Oncology Group (ECOG) Performance Grade of 0 or 1
  8. Patients must be free of clinically significant infection.

Exclusion Criteria:

  1. Patients who have progressed through or recurred within 3 months of treatment with a taxane agent administered on a weekly basis.
  2. Patients who have previously been treated with bevacizumab or other anti-angiogenic agents
  3. Patients who are less than 4 weeks from prior chemotherapy and/or radiation therapy
  4. Patients with ECOG Performance Grade of 2, 3 or 4
  5. Patients with a history of other invasive malignancies, with the exception of non-melanoma skin cancer, are excluded if there is any evidence of other malignancy being present within the last 5 years. Patients are also excluded if their previous cancer treatment contraindicates this protocol therapy
  6. Subjects meeting any of the following criteria are ineligible for study entry: (a) Inability to comply with study and/or follow-up procedures (b) 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
  7. Inadequately controlled hypertension (defined as systolic blood pressure >140 or diastolic blood pressure > 90 mmHg on antihypertensive medications)
  8. Any prior history of hypertensive crisis or hypertensive encephalopathy
  9. New York Heart Association (NYHA) Grade II or greater congestive heart failure
  10. History of myocardial infarction or unstable angina within 6 months prior to study enrollment
  11. History of stroke or transient ischemic attack within 6 months prior to study enrollment
  12. Known metastatic cervical cancer to the central nervous system
  13. Significant vascular disease (e.g., aortic aneurysm, aortic dissection)
  14. Symptomatic peripheral vascular disease
  15. Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to study enrollment or anticipation of need for major surgical procedure during the course of the study
  16. Core biopsy or other minor surgical procedure, excluding placement of a vascular access device, within 7 days prior to study enrollment
  17. History of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 6 months prior to study enrollment
  18. Serious, non-healing wound, ulcer, or bone fracture
  19. Proteinuria at screening as demonstrated by urine dipstick for proteinuria > / = 2+ (patients discovered to have > / = 2+ proteinuria on dipstick urinalysis at baseline should undergo a 24 hour urine collection and must demonstrate < / = 1g of protein in 24 hours to be eligible)
  20. Known hypersensitivity to any component of bevacizumab
  21. Pregnant (positive pregnancy test) or lactating
  22. Patients receiving black cohosh, dong quai, valerian, St. John's wort, kava kava, gotu kola. Patient cannot have received these medications within 14 days of therapy start.
  23. Patients with a known hypersensitivity to taxanes, Cremophor EL (polyoxyethylated castor oil), or any component of the formulation.
  24. History of hemoptysis (>/= ½ teaspoon of bright red blood per episode) within 1 month prior to Day 1
  25. Evidence of bleeding diathesis or significant coagulopathy (in the absence of therapeutic anticoagulation)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00626561

Locations
United States, Texas
UT MD Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
M.D. Anderson Cancer Center
Genentech, Inc.
Investigators
Principal Investigator: Michael M. Frumovitz, MD UT MD Anderson Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT00626561     History of Changes
Other Study ID Numbers: 2007-0324
Study First Received: February 20, 2008
Results First Received: June 5, 2014
Last Updated: June 5, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by M.D. Anderson Cancer Center:
Cervical Cancer
Uterine Cancer
Bevacizumab
Avastin
Anti-VEGF monoclonal antibody
rhuMAb-VEGF
Paclitaxel
Taxol

Additional relevant MeSH terms:
Neuroendocrine Tumors
Uterine Cervical Neoplasms
Uterine Neoplasms
Genital Diseases, Female
Genital Neoplasms, Female
Neoplasms
Neoplasms by Histologic Type
Neoplasms by Site
Neoplasms, Germ Cell and Embryonal
Neoplasms, Nerve Tissue
Neuroectodermal Tumors
Urogenital Neoplasms
Uterine Cervical Diseases
Uterine Diseases
Antibodies, Monoclonal
Bevacizumab
Paclitaxel
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Antimitotic Agents
Antineoplastic Agents
Antineoplastic Agents, Phytogenic
Growth Inhibitors
Growth Substances
Immunologic Factors
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on October 23, 2014