3-AP and Gemcitabine in Treating Patients With Recurrent, Unresectable, or Metastatic Pancreatic Cancer

NCT00078975 | Completed Phase 2

• 3 other identifiers: PMH-PHL-023CDR0000353205NCI-6271
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 4

Brief Summary

RATIONALE: Drugs used in chemotherapy, such as 3-AP and gemcitabine, work in different ways to stop tumor cells from dividing so they stop growing or die. 3-AP may help gemcitabine kill more tumor cells by making them more sensitive to the drug. PURPOSE: This phase II trial is studying how well giving 3-AP together with gemcitabine works in treating patients with recurrent, unresectable, or metastatic pancreatic cancer.

Conditions

Pancreatic Cancer

Keywords

adenocarcinoma of the pancreas; recurrent pancreatic cancer; stage II pancreatic cancer; stage III pancreatic cancer; stage IV pancreatic cancer

Outcome Measures

Primary Outcomes (2)

• Objective response (complete and partial)

  Every 8 weeks for the duration of the trial, an expected average of 5 years

• Prolonged stable disease rate

  Stable disease of 6 or more months

Secondary Outcomes (5)

• Median survival

  For duration of trial, an expected average of 5 years

• Survival rate at 1 year

  1 year

• Response duration

  From date of response until progression

• Progression-free survival

  From date of response until progression or death

• Safety and tolerability

  Up to 1 year

Study Arms (1)

Triapine in combination with Gemcitabine

EXPERIMENTAL

Drug: gemcitabine hydrochloride; Drug: triapine

Interventions

gemcitabine hydrochloride DRUG

Triapine in combination with Gemcitabine

triapine DRUG

Triapine in combination with Gemcitabine

Eligibility Criteria

• Age: 18 Years - 120 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

DISEASE CHARACTERISTICS: * Histologically or cytologically confirmed pancreatic adenocarcinoma * Recurrent, unresectable, or metastatic disease * At least 1 unidimensionally measurable lesion * At least 20 mm by conventional techniques OR at least 10 mm by spiral CT scan * Prior radiation field must not have encompassed the only site of measurable disease * No known brain metastases PATIENT CHARACTERISTICS: Age * 18 and over Performance status * ECOG 0-2 OR * Karnofsky 60-100% Life expectancy * More than 12 weeks Hematopoietic * WBC ≥ 3,000/mm\^3 * Absolute neutrophil count ≥ 1,500/mm\^3 * Platelet count ≥ 100,000/mm\^3 * No G6PD deficiency Hepatic * Bilirubin ≤ 1.5 times normal * AST and ALT ≤ 2.5 times upper limit of normal Renal * Creatinine ≤ 1.5 times normal OR * Creatinine clearance ≥ 60 mL/min Cardiovascular * No unstable angina pectoris * No cardiac arrhythmia * No symptomatic congestive heart failure Pulmonary * No severe pulmonary disease * No dyspnea at rest * No dependence on supplemental oxygen use Other * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception during and for 3 months after study treatment * No prior allergic reaction attributed to compounds of similar chemical or biological composition to study drugs * No ongoing or active infection * No psychiatric illness or social situation that would preclude study compliance * No other concurrent uncontrolled illness that would preclude study participation PRIOR CONCURRENT THERAPY: Biologic therapy * Not specified Chemotherapy * No prior chemotherapy except fluorouracil given as adjuvant therapy OR as a radiosensitizer during radiotherapy * More than 4 weeks since prior adjuvant fluorouracil therapy Endocrine therapy * Not specified Radiotherapy * See Disease Characteristics * See Chemotherapy * More than 4 weeks since prior radiotherapy and recovered Surgery * Not specified Other * No other concurrent investigational agents * No other concurrent anticancer therapy * No concurrent combination antiretroviral therapy for HIV-positive patients

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• University Health Network, Toronto: lead
• National Cancer Institute (NCI): collaborator

Study Sites (4)

Margaret and Charles Juravinski Cancer Centre

Hamilton, Ontario, L8V 5C2, Canada

Location

London Regional Cancer Program at London Health Sciences Centre

London, Ontario, N6A 4L6, Canada

Location

Ottawa Hospital Regional Cancer Centre - General Campus

Ottawa, Ontario, K1H 1C4, Canada

Location

Princess Margaret Hospital

Toronto, Ontario, M5G 2M9, Canada

Location

MeSH Terms

Conditions

Pancreatic Neoplasms

Interventions

Gemcitabine; 3-aminopyridine-2-carboxaldehyde thiosemicarbazone

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring

Study Officials

• Malcolm J. Moore, MD

  Princess Margaret Hospital, Canada

  PRINCIPAL INVESTIGATOR

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: March 8, 2004
• First Posted: March 9, 2004
• Study Start: April 1, 2004
• Primary Completion: December 1, 2005
• Study Completion: January 7, 2009
• Last Updated: September 14, 2018

Record last verified: 2018-09

Locations

CA (4)