Bevacizumab and Paclitaxel for Neuroendocrine Tumors of the Cervix

NCT00626561 | Terminated Phase 2 Results

• 1 other identifier: 2007-0324
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 1

Brief Summary

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. 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. 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. 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. 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.

Conditions

Cervical Cancer; Uterine Cancer

Keywords

Cervical Cancer; Uterine Cancer; Bevacizumab; Avastin; Anti-VEGF monoclonal antibody; rhuMAb-VEGF; Paclitaxel; Taxol

Outcome Measures

Primary Outcomes (1)

• Progression-free Survival (PFS)

  Progression-Free Survival is the period from study entry until disease progression, death or date of last contact.

  Baseline to 6 Months, or until disease progression.

Study Arms (1)

Bevacizumab + Paclitaxel

EXPERIMENTAL

Bevacizumab 10 mg/kg intravenous (IV) twice weekly and Paclitaxel 60 mg/m\^2 IV weekly.

Drug: Bevacizumab; Drug: Paclitaxel

Interventions

Bevacizumab DRUG

10 mg/kg IV twice weekly on days 1 and 15.

Also known as: Avastin, Anti-VEGF monoclonal antibody, rhuMAb-VEGF

Bevacizumab + Paclitaxel

Paclitaxel DRUG

60 mg/m\^2 IV weekly on days 1, 8, 15, and 22.

Also known as: Taxol

Bevacizumab + Paclitaxel

Eligibility Criteria

• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with histologically confirmed, advanced stage (stage IVB), recurrent, or persistent small cell, large cell, or neuroendocrine tumor of the uterine corpus and cervix
• 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.
• 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.
• 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
• 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.
• Patients must have signed an approved informed consent and authorization permitting release of personal health information.
• Patients with Eastern Cooperative Oncology Group (ECOG) Performance Grade of 0 or 1
• Patients must be free of clinically significant infection.

You may not qualify if:

• Patients who have progressed through or recurred within 3 months of treatment with a taxane agent administered on a weekly basis.
• Patients who have previously been treated with bevacizumab or other anti-angiogenic agents
• Patients who are less than 4 weeks from prior chemotherapy and/or radiation therapy
• Patients with ECOG Performance Grade of 2, 3 or 4
• 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
• 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
• Inadequately controlled hypertension (defined as systolic blood pressure \>140 or diastolic blood pressure \> 90 mmHg on antihypertensive medications)
• Any prior history of hypertensive crisis or hypertensive encephalopathy
• New York Heart Association (NYHA) Grade II or greater congestive heart failure
• History of myocardial infarction or unstable angina within 6 months prior to study enrollment
• History of stroke or transient ischemic attack within 6 months prior to study enrollment
• Known metastatic cervical cancer to the central nervous system
• Significant vascular disease (e.g., aortic aneurysm, aortic dissection)
• Symptomatic peripheral vascular disease
• 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

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead
• Genentech, Inc.: collaborator

Study Sites (1)

UT MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

• MD Anderson Cancer Center

MeSH Terms

Conditions

Uterine Cervical Neoplasms; Uterine Neoplasms

Interventions

Bevacizumab; Paclitaxel

Condition Hierarchy (Ancestors)

Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes

Results Point of Contact

• Title: Michael M. Frumovitz, MD / Professor, Gynecologic Oncology
• Organization: University of Texas MD Anderson Cancer Center

CR_Study_Registration@mdanderson.org

713-792-9599

Study Officials

• Michael M. Frumovitz, MD

  UT MD Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• 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: SPONSOR

Study Record Dates

• First Submitted: February 20, 2008
• First Posted: February 29, 2008
• Study Start: February 1, 2008
• Primary Completion: July 1, 2011
• Study Completion: July 1, 2011
• Last Updated: July 7, 2014
• Results First Posted: July 7, 2014

Record last verified: 2014-06

Locations

US (1)