Chloroquine in Combination With Carboplatin/Gemcitabine in Advanced Solid Tumors

Phase 1

Completed

• Conditions: Solid Tumors; Malignant Neoplasm
• Interventions: Drug: Chloroquine; Drug: Carboplatin; Drug: Gemcitabine

• Registration Number: NCT02071537
• Lead Sponsor: University of Cincinnati

Brief Summary

The purpose of this research study is to test the safety of chloroquine in combination with carboplatin and gemcitabine and see what effects (good and bad) it has on advanced solid tumors.

Also, the research study will be increasing the dose of chloroquine to find the highest dose of chloroquine that can be given in combination with carboplatin and gemcitabine without causing severe side effects.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-02-19
• Study First Submitted QC: 2014-02-21
• Study First Posted: 2014-02-26
• Study Start: 2014-05-13
• Primary Completion: 2018-03-03
• Study Completion: 2018-12
• Status Verified: 2019-11
• Last Update Submitted: 2019-11-21
• Last Update Posted: 2019-11-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

Inclusion Criteria

• Histologically confirmed diagnosis of a malignancy that is metastatic or unresectable and for which either standard curative measures do not exist or are no longer effective and carboplatin/gemcitabine is considered a reasonable treatment option whether first line or acceptable and approved combination therapy.
• Age >18 years of age.
• Performance status less than or equal 2 (Karnofsky >60%)
• Life expectancy of greater than 3 months.
• Adequate labs
• Measurable disease

Exclusion Criteria

• Current treatment with any other investigational agents.
• Patients with untreated brain metastases
• History of allergic reaction attributed to compounds of similar chemical or biologic composition to chloroquine or other agents used in study.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Chloroquine with Carboplatin/Gemcitabine	Carboplatin	Chloroquine administered orally daily to start one week prior to Carboplatin (AUC5)/Gemcitabine (1250mg/m2). Chloroquine dose is escalating.
Chloroquine with Carboplatin/Gemcitabine	Chloroquine	Chloroquine administered orally daily to start one week prior to Carboplatin (AUC5)/Gemcitabine (1250mg/m2). Chloroquine dose is escalating.
Chloroquine with Carboplatin/Gemcitabine	Gemcitabine	Chloroquine administered orally daily to start one week prior to Carboplatin (AUC5)/Gemcitabine (1250mg/m2). Chloroquine dose is escalating.

Primary Outcome Measures

Name	Time	Method
Maximum tolerated dose of chloroquine when combined with Carboplatin/Gemcitabine	Up to 12 months

Secondary Outcome Measures

Name	Time	Method
Time of Overall Survival	Up to 24 months
Time to Disease Progression	Up to 24 months

Trial Locations

Locations (1)

University of Cincinnati Cancer Institute; 🇺🇸 Cincinnati, Ohio, United States