Adjuvant Effect of Chloroquine on Gemcitabine

NCT01777477 | Completed Phase 1 DMC

• 1 other identifier: ONK-USZ-004
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to evaluate the safety by defining the maximum tolerated dose (MTD) of Choloroquine when combined with Gemcitabine, and to evaluate preliminary efficacy of combined systemic Gemcitabine and Chloroquine. In addition, the influence of the treatment on the anti-cancer immunity and the value of GOLPH2 as serum marker for pancreatic cancer will be assessed within a translational objective.

• Trial with medicinal product

Conditions

Pancreatic Cancer

Outcome Measures

Primary Outcomes (1)

• Maximum tolerated dose (MTD) of orally administered Chloroquine with concomitant intravenous Gemcitabine.

  8 weeks

Study Arms (1)

Chloroquin in addition to Gemcitabine

EXPERIMENTAL

Gemcitabine 1000 mg/m2 i.v. at days 1, 8, 15 of every 28-day cycle. Chloroquine 100 mg, 200 mg or 300 mg (according to dose level) p.o. at days 2, 9, 16 of every 28-day cycle.

Drug: Chloroquine; Drug: Gemcitabine

Interventions

Chloroquine DRUG

Addition of Chloroquine to Gemcitabine

Also known as: Nivaquin

Chloroquin in addition to Gemcitabine

Gemcitabine DRUG

Also known as: Gemzar

Chloroquin in addition to Gemcitabine

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 non-resectable locally advanced or metastatic adenocarcinoma of the pancreas. Assessment is done within 21 days before enrolment.
• Age = 18 years
• Adequate liver function or kidney function tests, including any of the following: Bilirubin \< 2 x ULN, Alanin-Aminotransferase (ALT) \< 5 x ULN, Alcaline phosphatase \< 5 x ULN, Estimated creatinine clearance \> 40 ml/min (using the Cockroft formula)
• Adequate haematological values: Haemoglobin \> 80 g/L, Leukocytes \>3.00 g/L, Neutrophils \> 1.00 g/L, Platelets \> 100 g/L
• Written informed consent
• Men who agree not to father a child during participation in the trial or during the 12 months thereafter.
• Patient compliance and geographic proximity allow proper staging and follow-up. Patient not eligible for FOLFIRINOX treatment. WHO PS 0-2

You may not qualify if:

• Life expectancy \< 3 months
• Severe medical or psychiatric co-morbidity prohibiting the planned treatment or the giving of informed consent
• Any prior chemotherapy for pancreatic cancer, including adjuvant chemotherapy.
• Known hypersensitivity to trial drugs or hypersensitivity to any other component of the trial drugs.
• Known glucose-6-phosphate dehydrogenase deficiency.
• Concurrent use of other experimental drugs, treatment within a clinical trial within 30 days prior to trial entry.
• Active heart disease defined as congestive heart failure \> NYHA class 2
• Past or current history (within the last 2 years prior to treatment start) of other malignancies except basal or squamous cell carcinoma of the skin or in situ carcinoma of the cervix
• Inability or unwillingness to comply with the study protocol
• No understanding of the german language

Sponsors & Collaborators

• University of Zurich: lead

Study Sites (1)

University Hospital Zurich, Department of Oncology

Zurich, Canton of Zurich, 8091, Switzerland

Location

MeSH Terms

Conditions

Pancreatic Neoplasms

Interventions

Chloroquine; 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)

Aminoquinolines; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring

Study Officials

• Panagiotis Samaras, MD

  University Hospital Zurich, Department of Oncology

  PRINCIPAL INVESTIGATOR

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 23, 2013
• First Posted: January 28, 2013
• Study Start: July 1, 2012
• Primary Completion: May 1, 2015
• Study Completion: May 1, 2015
• Last Updated: September 22, 2015

Record last verified: 2015-09

Locations

CH (1)