3-AP and Radiation Therapy in Treating Patients With Stage III Pancreatic Cancer That Cannot Be Removed By Surgery

NCT00288093 | Completed Phase 1

• 9 other identifiers: NCI-2009-0012005011OSU-2005C0030CSU-05011CDR0000455065NCI-70447044P30CA016058U01CA076576
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

This phase I trial is studying the side effects and best dose of 3-AP when given together with radiation therapy in treating patients with stage III pancreatic cancer that cannot be removed by surgery. 3-AP may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Radiation therapy uses high-energy x-rays to kill tumor cells. 3-AP may make tumor cells more sensitive to radiation therapy. Giving 3-AP together with radiation therapy may kill more tumor cells.

Conditions

Pancreatic Adenocarcinoma; Stage III Pancreatic Cancer AJCC v6 and v7

Outcome Measures

Primary Outcomes (1)

• MTD as assessed by the number of patients with dose-limiting toxicity (DLT)

  MTD will be the dose at which 1 or fewer patients (less than or equal to 1/6) experiences a DLT during the treatment cycle with the next higher dose having at least 2/3 or 2/6 patients experiencing DLT. DLT will be defined as greater than or equal to Grade 3 non-hematologic or greater than or equal to Grade 4 hematologic adverse event with the following exceptions: greater than or equal to Grade 3 nausea and greater than or equal to Grade 3 vomiting that improves with antiemetic therapy greater than or equal to Grade 3 diarrhea that improves with Lomotil.

  Observed clinically for 3-4 hours after each 3-AP infusion during the first week of treatment

Secondary Outcomes (3)

• Levels of dCTP in PBMCs correlated to activity and toxicity of 3-AP

  Immediately before and after 3-AP on the first and last day of treatment

• Radiographic correlates using secretin-stimulated MRCP and dynamic contrast enhanced MRI

  Prior to treatment (baseline), 2 weeks within and 4 weeks after combined-modality therapy

• Therapeutic response as assessed using the Response Evaluation Criteria in Solid Tumors (RECIST)

  CT scans at baseline and 4 weeks from end of therapy and then every 2 months for 1 year from start of therapy. Confirmatory scans will also be obtained 2 months following initial documentation of an objective response.

Study Arms (1)

Treatment (triapine, radiation therapy)

EXPERIMENTAL

Patients undergo radiotherapy once daily, 5 days a week, for approximately 5.5 weeks (a total of 28 fractions). Patients also receive 3-AP (Triapine) IV over 2 hours 3 days a week every other week for 5.5 weeks. Treatment continues in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of 3-AP (Triapine) until the maximum tolerated dose (MTD) is determined.

Radiation: 3-Dimensional Conformal Radiation Therapy; Drug: Triapine

Interventions

3-Dimensional Conformal Radiation Therapy RADIATION

Treatment (triapine, radiation therapy)

Triapine DRUG

Treatment (triapine, radiation therapy)

Eligibility Criteria

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

You may qualify if:

• Histologically or cytologically confirmed adenocarcinoma of the pancreas
• Unresectable nonmetastatic (stage III) disease
• ECOG performance status 0-2
• Life expectancy \> 12 weeks
• WBC ≥ 3,000/mm\^3
• Absolute neutrophil count ≥ 1,500/mm\^3
• Platelet count ≥ 100,000/mm\^3
• Total bilirubin ≤ 2 times upper limit of normal (ULN)
• AST/ALT ≤ 3 times ULN
• Creatinine normal ORcreatinine clearance ≥ 60 mL/min
• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective contraception prior to and during study treatment
• No history of allergic reactions attributed to compounds of similar chemical or biologic composition to 3-AP (Triapine®) or other agents used in study
• No known glucose-6-phosphate dehydrogenase (G6PD) deficiency

Sponsors & Collaborators

• National Cancer Institute (NCI): lead

Study Sites (1)

Ohio State University Comprehensive Cancer Center

Columbus, Ohio, 43210, United States

Location

MeSH Terms

Interventions

Radiotherapy, Conformal; 3-aminopyridine-2-carboxaldehyde thiosemicarbazone

Intervention Hierarchy (Ancestors)

Radiotherapy, Computer-Assisted; Radiotherapy; Therapeutics

Study Officials

• Tanios Bekaii-Saab

  Ohio State University Comprehensive Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: February 6, 2006
• First Posted: February 7, 2006
• Study Start: December 20, 2006
• Primary Completion: December 28, 2012
• Study Completion: December 28, 2012
• Last Updated: August 18, 2017

Record last verified: 2017-08

Locations

US (1)