Avastin, Fluorouracil, Doxorubicin and Streptozocin in Locally Advanced and Metastatic Pancreatic Endocrine Tumors

NCT00609765 | Terminated Phase 2 Results DMC

• 2 other identifiers: MCC-14961AVF3915s
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 1

Brief Summary

Open label, single-arm phase II study of avastin combined with fluorouracil, doxorubicin and streptozocin administered in 28-day cycles. Treatment will continue until progression of disease, or until withdrawal due to toxicity, or up to a maximum of 12 cycles (48 weeks). In order to reduce the risk of cardiac toxicity, doxorubicin will be administered for a maximum of 8 cycles. If disease has not progressed after 12 cycles of treatment, avastin monotherapy will continue until disease progression or withdrawal due to toxicity.

Conditions

Pancreatic Cancer

Keywords

advanced; unresectable; metastatic; endocrine; tumors

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Progression Free Survival (PFS) at 12 Months

  We planned to calculate the One Year Progression Free Survival rate. The event for PFS analyses was the first occurrence of disease progression or death and patients who did not progress or died would be censored at the date of last tumor evaluation (e.g. one-year).

  12 months

Secondary Outcomes (1)

• The Number of Participants With Radiographic Response

  2 years

Study Arms (1)

Protocol Specified Chemotherapy

EXPERIMENTAL

Protocol Specified Chemotherapy Every 28 Days: Avastin, Fluorouracil, Doxorubicin, Streptozocin. Premedications: Dexamethasone, Ondansetron

Drug: Avastin; Drug: Fluorouracil; Drug: Doxorubicin; Drug: Streptozocin; Drug: Dexamethasone; Drug: Ondansetron

Interventions

Avastin DRUG

Every 28 Days: Avastin 5mg/kg iv days 1 and 15

Also known as: bevacizumab

Protocol Specified Chemotherapy

Fluorouracil DRUG

Every 28 Days: Fluorouracil 400mg/m\^2 iv bolus daily days 1-5

Also known as: Fluoroplex, 5-FU, Efudex

Protocol Specified Chemotherapy

Doxorubicin DRUG

Every 28 Days: Doxorubicin 40mg/m\^2 iv bolus day 1

Also known as: Adriamycin®

Protocol Specified Chemotherapy

Streptozocin DRUG

Every 28 Days: Streptozocin 400mg/m2 iv bolus daily days 1-5

Also known as: Zanosar®

Protocol Specified Chemotherapy

Dexamethasone DRUG

Premedication: Dexamethasone 20mg intravenously days 1-5

Also known as: Decadron

Protocol Specified Chemotherapy

Ondansetron DRUG

Premedication: Ondansetron 16mg intravenously days 1-5

Also known as: Zofran

Protocol Specified Chemotherapy

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients must have locally advanced (unresectable) or metastatic, well or moderately differentiated pancreatic endocrine tumors.
• Measurable disease on CT scan or MRI.
• Age ≥ 18 years and ≤ 80 years.
• Use of effective means of contraception (men and women) in subjects of child-bearing potential
• Adequate renal function (serum creatinine ≤1.5, urine protein:creatinine ratio \<1.0 or 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 ≤ 1 g of protein in 24 hours to be eligible).
• Adequate hepatic function (bilirubin ≤2.0, AST and ALT ≤ 3x ULN.
• Adequate hematologic function (WBC ≥ 3,000, ANC ≥ 1500, platelets ≥ 100,000)

You may not qualify if:

• Prior therapy with fluorouracil, doxorubicin, streptozocin or avastin
• Ejection fraction on MUGA \<50%
• ECOG performance status \> 2
• 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 avastin cancer study
• Inadequately controlled hypertension (defined as systolic blood pressure \>150 and/or diastolic blood pressure \> 100 mmHg on antihypertensive medications)
• Any prior history of hypertensive crisis or hypertensive encephalopathy
• Unstable angina
• 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
• Significant vascular disease (e.g., aortic aneurysm, aortic dissection)
• Symptomatic 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

Sponsors & Collaborators

• H. Lee Moffitt Cancer Center and Research Institute: lead
• Genentech, Inc.: collaborator

Study Sites (1)

H. Lee Moffitt Cancer Center and Research Institute

Tampa, Florida, 33612, United States

Location

MeSH Terms

Conditions

Pancreatic Neoplasms; Neoplasm Metastasis; Neoplasms

Interventions

Bevacizumab; Fluorouracil; Doxorubicin; Streptozocin; Dexamethasone; Calcium Dobesilate; Ondansetron

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Uracil; Pyrimidinones; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Daunorubicin; Anthracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds; Aminoglycosides; Glycosides; Carbohydrates; Nitrosourea Compounds; Urea; Amides; Nitroso Compounds; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Steroids, Fluorinated; Benzenesulfonates; Benzene Derivatives; Arylsulfonates; Arylsulfonic Acids; Sulfonic Acids; Sulfur Acids; Sulfur Compounds; Imidazoles; Azoles; Carbazoles; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds, 3-Ring

Limitations and Caveats

This trial only enrolled one patient and was closed because of development of a new chemotherapy standard of care for treatment of this cancer which we felt rendered the trial obsolete. The trial was open for only 7 months.

Results Point of Contact

• Title: Jonathan Strosberg, M.D.
• Organization: H. Lee Moffitt Cancer Center and Research Institute

jonathan.strosberg@moffitt.org

813-745-2069

Study Officials

• Larry Kvols, M.D.

  H. Lee Moffitt Cancer Center and Research Institute

  PRINCIPAL INVESTIGATOR

• Jonathan Strosberg, M.D.

  H. Lee Moffitt Cancer Center and Research Institute

  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: January 24, 2008
• First Posted: February 7, 2008
• Study Start: August 1, 2007
• Primary Completion: March 1, 2008
• Study Completion: March 1, 2008
• Last Updated: March 23, 2017
• Results First Posted: March 22, 2011

Record last verified: 2011-03

Locations

US (1)