Dose-Escalation Study of Intensity-Modulated Radiotherapy(IMRT)in Patients With Unresectable Pancreatic Cancer

NCT00593866 | Completed Phase 1 Results DMC

• 2 other identifiers: UMCC 2006.018IRB #HUM3315
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 2

Brief Summary

This is a research study for pancreatic cancer. One way of improving the results of current standard treatments is to try new approaches. This study will examine the use of a more advanced radiation therapy technique, called intensity modulated radiation therapy (IMRT), with chemotherapy. All subjects on this study will be treated with gemcitabine. This chemotherapy agent has been used for patients with pancreatic cancer. The researchers have already done studies using radiation therapy and gemcitabine. They want to build on the information they have from this previous research. The researchers want to find the best dose of IMRT that can be given at the same time that patients are receiving gemcitabine. To do this, they will vary the total dose of radiation received by patients on this study based on the information they have available from previously treated patients. The goal of the research is to identify the highest dose of IMRT that can be given at the same time as the chemotherapy without causing severe side effects.

Conditions

Pancreatic Cancer

Keywords

Patients who have confirmed cancer arising from the pancreas

Outcome Measures

Primary Outcomes (1)

• The Maximum Tolerated Radiation Dose

  The maximum tolerated radiation dose delivered with intensity-modulated radiotherapy (IMRT) and concurrent gemcitabine in patients with unresectable adenocarcinoma of the pancreas.

  13 weeks post radiation

Secondary Outcomes (1)

• The Percentage of Participants Free From Local Progression at 2 Years

  2 Years

Study Arms (1)

Radiation Dose Escalation with Gemcitabine

EXPERIMENTAL

INTENSITY MODULATED RADIOTHERAPY Radiation dose escalation: Total dose Dose per fraction BED\* Dose equivalent (1.8 Gy/fraction) Level 1 45.0 1.8 53.1 45.0 Level 2 50.0 2.0 60.0 50.4 Level 3 52.5 2.1 63.5 54.0 Level 4 55.0 2.2 67.1 57.0 Level 5 57.5 2.3 70.7 60.0 Level 6 60.0 2.4 74.4 63.0 Level 7 62.5 2.5 78.1 66.2 Level 8 65.0 2.6 81.9 69.4 * BED=Biological Effective Dose; =10 Five fractions weekly, fraction size determined by dose level Gemcitabine: 1000mg/m2 will be infused over 100 minutes on days 1, 8, 22 and 29 of the radiation treatment

Radiation: INTENSITY MODULATED RADIOTHERAPY; Drug: Gemcitabine

Interventions

INTENSITY MODULATED RADIOTHERAPY RADIATION

Five fractions weekly, fraction size determined by dose level

Also known as: Radiation dose escalation:, Total dose Dose per fraction BED* Dose equivalent (1.8 Gy/fraction), Level 1 45.0 1.8 53.1 45.0, Level 2 50.0 2.0 60.0 50.4, Level 3 52.5 2.1 63.5 54.0, Level 4 55.0 2.2 67.1 57.0, Level 5 57.5 2.3 70.7 60.0, Level 6 60.0 2.4 74.4 63.0, Level 7 62.5 2.5 78.1 66.2, Level 8 65.0 2.6 81.9 69.4, * BED=Biological Effective Dose; =10

Radiation Dose Escalation with Gemcitabine

Gemcitabine DRUG

1000mg/m2 will be infused over 100 minutes on days 1, 8, 22 and 29 of the radiation treatment

Radiation Dose Escalation with Gemcitabine

Eligibility Criteria

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

You may qualify if:

• Is the patient 18 years of age or older.
• Does the patient have histologically or cytologically proven carcinoma of the pancreas
• Is the tumor unresectable or medically inoperable
• Does the patient have a Zubrod performance status of ≤ 2 (appendix I).
• Does the patient have an absolute neutrophil count of ≥ 1500/mm3, and platelets ≥ 100,000/mm3
• Does the patient have adequate renal function (creatinine \< 2 mg/dl) and hepatic function (bilirubin \< 3 mg/dl), with relief of biliary obstruction if present
• Is the patient free of significant co-morbid conditions that would preclude safe administration or completion of protocol therapy
• If the patient is of reproductive potential, has he or she agreed to use an effective method of contraception during treatment on this trial and for 6 months after treatment
• Is the patient aware of the investigational nature of the therapy such that they can provide written informed consent

You may not qualify if:

• Does the patient have a neuroendocrine tumor of the pancreas
• Does the patient have metastatic disease
• Does the patient have a history of abdominal radiation therapy
• Is there history of more than 1 month of therapy with single agent gemcitabine
• Has the patient used any investigational agent in the month before enrollment into the study

Sponsors & Collaborators

• University of Michigan Rogel Cancer Center: lead
• Rush University Medical Center: collaborator

Study Sites (2)

Rush University Medical Center

Chicago, Illinois, 60612-3833, United States

Location

University Of Michigan

Ann Arbor, Michigan, 48109-5010, United States

Location

MeSH Terms

Conditions

Pancreatic Neoplasms

Interventions

Radiotherapy, Intensity-Modulated; Gemcitabine

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Radiotherapy, Conformal; Radiotherapy, Computer-Assisted; Radiotherapy; Therapeutics; Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring

Results Point of Contact

• Title: Dr. Mark Zalupski
• Organization: University of Michigan Comprehensive Cancer Center

zalupski@umich.edu

734-615-3969

Study Officials

• Mark Zalupski, MD

  University of Michigan

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 2, 2008
• First Posted: January 15, 2008
• Study Start: June 1, 2006
• Primary Completion: May 1, 2012
• Study Completion: October 1, 2014
• Last Updated: September 11, 2015
• Results First Posted: August 27, 2014

Record last verified: 2015-08

Locations

US (2)