Avastin/[18-F]-5-fluorouracil PET/CT Imaging Feasibility Project

Learn more about:
Related Clinical Trial
CRTE7A2-01 TCR-T Cell for HPV-16 Positive Advanced Cervical, Anal, or Head and Neck Cancers Assessment of Patients’ Quality of Sexual Life After Anal Cancer Treatment Neoadjuvant PD-1 Blockade Combined With Chemotherapy Followed by Concurrent Immunoradiotherapy for Locally Advanced Anal Canal Squamous Carcinoma Patients Pencil Beam Proton Therapy for Recurrences in Anal Cancer Patients Previously Treated With Radiotherapy (DACG 5) Hyperthermia Enhanced Re-irradiation of Loco-regional Recurrent Tumors Detecting HPV DNA in Anal and Cervical Cancers ANCA II – Quality of Life and Functional Outcome in Patients With Anal Cancer RTX-321 Monotherapy in Patients With HPV 16+ Tumors Anal Injury Screening for High Risk HPV M7824 in Subjects With HPV Associated Malignancies Multimodal Monitoring of Radiotherapy Response in Squamous Cell Cancer Avastin/[18-F]-5-fluorouracil PET/CT Imaging Feasibility Project Assessment of Health Related Quality of Life in Patients Treated for Rectal Cancer Octreotide in Preventing or Reducing Diarrhea in Patients Receiving Chemoradiotherapy for Anal or Rectal Cancer Combination Immunotherapy in Subjects With Advanced HPV Associated Malignancies Function Following Laser for Anal Intraepithelial Neoplasia (FLAN) A Message Framing Intervention for Increasing Parental Acceptance of Human Papillomavirus Vaccination Anal Sphincter Prosthesis in Treating Patients Who Are Undergoing Surgery for Anal or Rectal Cancer Phase 2 Study of ADXS11-001 in Subjects With Carcinoma of the Anorectal Canal Pilot Study to Determine the Safety and Efficacy of Gardasil Against the Human Papilloma Virus (HPV) in HIV-infected Men Assessment of Symptom-Related Cytokines in Lung and Gastrointestinal (GI) Cancer Patients Identification of Predictive Factors for Physiological Hypermetabolism of the Anal Canal in 18F-FDG PET / CT Early Rectal Cancer: Endoscopic Submucosal Dissection or Transanal Endoscopic Microsurgery? Drainage Seton With Flap Versus EAS Preserving Seton in Treatment of Transsphincteric Anal Fistula HPV-SAVE: 9-Valent HPV Vaccine for High-Grade Anal Dysplasia Radiation Dosimetry Study Comparing 2 Different Patient Setups in Anal/Rectal Cancer Patients Comparing Two Types of Swabs in Collecting Cell Samples for Anal Pap Tests and Human Papillomavirus Tests in Men Who Have Sex With Men The HPV-SAVE Study Team: HPV Screening and Vaccine Evaluation in Men Who Have Sex With Men High-Resolution Anoscopy Perceived Discomfort Study Infrared Coagulator Ablation or Observation in Preventing Anal Cancer in HIV-Positive Patients With Anal Neoplasia Image Fusion PET, CT and 3D-ultrasound Examinations Hybrid Capture 2 Human Papiloma Virus (HPV) High-Risk Anal DNA Test ART: Anal Squamous Cell Carcinoma: Investigation of Functional Imaging During chemoRadioTherapy Anal HPV Tests in Screening for Cell Changes in the Anus in Patients With HIV Molecular Genetic and Pathological Studies of Anal Tumors Intensity-Modulated Radiation Therapy, Fluorouracil, and Mitomycin C in Treating Patients With Invasive Anal Cancer Capecitabine, Oxaliplatin, and Radiation Therapy in Treating Patients With Stage II or Stage III Anal Cancer QOL & Functional Outcomes After Combined Modality Tx for Anal CA: Comparison of Conventional vs IMRT A Study of mDCF in Combination or Not With Atezolizumab in Advanced Squamous Cell Anal Carcinoma Chemotherapy Plus Radiation Therapy in Treating Patients With Stage II or Stage III Anal Cancer Infrared Coagulation in Preventing Anal Cancer in Patients With HIV Who Have Anal Neoplasia Combination Chemotherapy Plus Radiation Therapy in Treating Patients With Stage II or Stage III Anal Cancer Topical MTS-01 for Dermatitis During Radiation and Chemotherapy for Anal Cancer Radiochemotherapy +/- Durvalumab for Locally-advanced Anal Carcinoma. A Multicenter, Randomized, Phase II Trial of the German Anal Cancer Study Group Intrafractional Vaginal Dilation in Anal Cancer Patients Undergoing Pelvic Radiotherapy Screening for HIV-Associated Anal Cancer Combined Modality Therapy for Patients With With HIV and Stage I, Stage II, or Stage III Anal Cancer Cetuximab, Cisplatin, Fluorouracil, and Radiation Therapy in Treating Patients With Anal Cancer Study of IMRT Radiotherapy Concurrent Chemothrerapy for Anal Cancer A Prospective, Open-Label, Multi-center Comparison of Lymphoseek Identified Lymph Nodes and Clinically Identified Lymph Nodes of Subjects With Known Cancer of the Anus Prospective Observational Trial to Evaluate Quality of Life After Definitive Chemoradiation in Patients With Anal Cancer (LANACARE) Radiation Therapy Plus Fluorouracil With or Without Additional Chemotherapy in Treating Patients With Primary Anal Cancer Prospective Cohort on Quality of Sexual Life Among Men Who Have Sex With Men Treated for Anal Cancer With Concurrent Chemotherapy and Intensity-modulated Radiotherapy Trial To Test Safety And Efficacy Of Vaccination For Incurable HPV 16-Related Oropharyngeal, Cervical And Anal Cancer SGN-00101 in Preventing Anal Cancer in Patients With HIV Who Have Anal Neoplasia Anal Cancer Radiotherapy Study Radiation Therapy, Mitomycin, and Either Fluorouracil or Cisplatin in Treating Patients With Locally Advanced Anal Cancer Radiation Therapy, Cisplatin, Fluorouracil, and Cetuximab in Treating Patients With Locally Advanced Anal Cancer Individual Following in Anal Cancer With PET/CT Anal Cancer Screening Study The Prevent Anal Cancer Self-Swab Study Shared Decision Making With Anal Cancer Patients on Radiation Dose Predictive Value of FMISO-PET, FDG-PET-CT, DWI-MRI and DCE-MRI Scans for Patients With Anal Cancer Receiving Radiotherapy +/- Chemotherapy Quality of Life in Patients With Anal Cancer Functional Outcomes Following Anal Cancer Treatment Pembrolizumab in Refractory Metastatic Anal Cancer A Phase I/II Evaluation of ADXS11-001, Mitomycin, 5-fluorouracil (5-FU) and IMRT for Anal Cancer

Brief Title

Avastin/[18-F]-5-fluorouracil PET/CT Imaging Feasibility Project

Official Title

Avastin/[18-F]-5-fluorouracil PET/CT Imaging Feasibility Project

Brief Summary

      To determine whether using a radiolabelled analog of 5-FU, [18F]-5-fluorouracil, for PET/CT
      imaging can visually demonstrate differential chemotherapy delivery to known tumor sites
      before and after administration of bevacizumab and determine the optimal timing of
      bevacizumab administration to maximize the chemotherapy delivery into the tumor for improved
      cancer treatment.
    



Study Type

Observational


Primary Outcome

Determine whether[18F]-5-Fluorouracil PET/CT scanning can demonstrate a difference in [18F]-5-Fluorouracil tumor uptake before and after the administration of Avastin

Secondary Outcome

 Determine if [18F]-5-Fluorouracil PET/CT imaging demonstrates that there is a difference in maximal [18F]-5-Fluorouracil tumor uptake that is dependent on the time point of post-Avastin scanning

Condition

Colorectal Neoplasms

Intervention

Bevacizumab


Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Drug

Estimated Enrollment

7

Start Date

February 2008

Completion Date

July 2010

Primary Completion Date

July 2009

Eligibility Criteria

        Inclusion Criteria:

          1. Patients must have histologically or cytologically confirmed adenocarcinoma of the
             colon.

          2. Patients must have metastatic disease to the liver with at least one lesion that is
             measurable by RECIST criteria within 4 weeks prior to entry of study

          3. Patients with a history of colon adenocarcinoma treated by surgical resection who
             develop radiological or clinical evidence of metastatic cancer do not require separate
             histological or cytological confirmation of metastatic disease unless an interval of >
             5 years has elapsed between the primary surgery and the development of metastatic
             disease. Clinicians should consider biopsy of lesions to establish diagnosis of
             metastatic colon adenocarcinoma if there is substantial clinical ambiguity regarding
             the nature or source of apparent metastases.

          4. Patients must have ECOG performance status of 0-2

          5. Patients must be >= 18 years of age

          6. Laboratory values <= 2 weeks prior to enrollment:

               -  Absolute Neutrophil Count (ANC) >= 1.5 x 10^9/L (>= 1500/mm^3)

               -  Platelets (PLT) >= 100 x 10^9/L >= 100,000/mm^3)

               -  Hemoglobin (Hgb) >= 9 g/dL

               -  Serum creatinine <= 1.5 ULN

               -  Serum bilirubin <= 1.5 ULN

               -  Aspartate aminotransferase (AST/SGOT) and alanine aminotransferase (ALT/SGPT) <=
                  3.0 x ULN (<= 5 x ULN if liver metastases present). Note: ERCP or percutaneous
                  stenting may be used to normalize the liver function tests.

               -  Negative for proteinuria based on dip stick reading OR, if documentation of +1
                  result for protein on dip stick reading, then total urinary protein <= 500 mg and
                  measured creatinine clearance (CrCl) >= 50 mL/min from a 24-hour urine collection

          7. Life expectancy >= 12 weeks

          8. Ability to give written informed consent according to local guidelines

        Exclusion Criteria:

          1. Patients receiving prior 5-FU for the treatment of metastatic colorectal
             adenocarcinoma will be excluded from enrollment. Previous use of 5-FU for adjuvant
             treatment of resected stage II or III colorectal adenocarcinoma will be allowed,
             provided the time from last 5-FU administration to enrollment is > 3 months.

          2. Prior full field radiotherapy <= 4 weeks or limited field radiotherapy <= 2 weeks
             prior to enrollment. Patients must have recovered from all therapy-related toxicities.
             The site of previous radiotherapy should have evidence of progressive disease if this
             is the only site of disease.

          3. Prior biologic or immunotherapy <= 2 weeks prior to registration. Patients must have
             recovered from all therapy-related toxicities

          4. Prior therapy with anti-VEGF agents

          5. Patients with a history of another primary malignancy <= 5 years, with the exception
             of inactive basal or squamous cell carcinoma of the skin

          6. Concurrent use of other investigational agents and patients who have received
             investigational drugs <= 4 weeks prior to enrollment.

          7. Female patients who are pregnant or breast feeding, or adults of reproductive
             potential not employing an effective method of birth control. Barrier contraceptives
             must be used throughout the trial in both sexes. Women of childbearing potential must
             have a negative serum pregnancy test 48 hours prior to administration of study
             treatment.

          8. Patients unwilling to or unable to comply with the protocol
      

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Dr Andrew Quon, , 

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT00661154

Organization ID

GIIMG0001

Secondary IDs

97291

Responsible Party

Sponsor

Study Sponsor

Stanford University

Collaborators

 Genentech, Inc.

Study Sponsor

Dr Andrew Quon, Principal Investigator, Stanford University


Verification Date

August 2012