Chloroquine in Combination With Carboplatin/Gemcitabine in Advanced Solid Tumors
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|ClinicalTrials.gov Identifier: NCT02071537|
Recruitment Status : Recruiting
First Posted : February 26, 2014
Last Update Posted : August 23, 2017
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.
|Condition or disease||Intervention/treatment||Phase|
|Malignant Neoplasm Solid Tumors||Drug: Chloroquine Drug: Carboplatin Drug: Gemcitabine||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase 1 Study of Chloroquine in Combination With Carboplatin/Gemcitabine in Advanced Solid Tumors|
|Study Start Date :||May 2014|
|Estimated Primary Completion Date :||January 2018|
|Estimated Study Completion Date :||December 2018|
Experimental: Chloroquine with Carboplatin/Gemcitabine
Chloroquine administered orally daily to start one week prior to Carboplatin (AUC5)/Gemcitabine (1250mg/m2). Chloroquine dose is escalating.
Dose is 50, 100, 150, and 200 mg per day cohorts. It is given one week prior to the initiation of chemotherapy and then given for four 21 day cycles in combination with chemotherapy.
Administered day 1 of each 21 day cycle for 4-6 cycles.
Administered days 1 and 8 of each 21 day cycle for 4-6 cycles.
Other Name: Gemzar
- Maximum tolerated dose of chloroquine when combined with Carboplatin/Gemcitabine [ Time Frame: Up to 12 months ]
- Time to Disease Progression [ Time Frame: Up to 24 months ]
- Time of Overall Survival [ Time Frame: Up to 24 months ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02071537
|Contact: UC Cancer Institute Clinical Trials Officeemail@example.com|
|United States, Ohio|
|University of Cincinnati Cancer Institute||Recruiting|
|Cincinnati, Ohio, United States, 45267-0502|
|Principal Investigator: Nagla Karim, MD, PhD|
|Sub-Investigator: Johm Morris, MD|
|Sub-Investigator: Sadia Benzaquin, MD|
|Sub-Investigator: Pankaj Desai, MS, PhD|
|Sub-Investigator: James Driscol, MD|
|Sub-Investigator: Ahmed Khaled, MD|
|Sub-Investigator: Jun Ying, PhD|
|Principal Investigator:||Nagla Abdel-Karim, MD||University of Cincinnati|