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NCT02071537 Clinical Trial

Chloroquine in Combination With Carboplatin/Gemcitabine in Advanced Solid Tumors

Solid Tumors Clinical Trial

Official title:
A Phase 1 Study of Chloroquine in Combination With Carboplatin/Gemcitabine in Advanced Solid Tumors

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02071537
Other study ID # UCCI-EXP-13-01
Secondary ID
Status Completed
Phase Phase 1
First received
Last updated
Start date May 13, 2014
Est. completion date December 2018

Study information
Verified date November 2019
Source University of Cincinnati
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 24
Est. completion date December 2018
Est. primary completion date March 3, 2018
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Related Conditions & MeSH terms

Intervention

Drug:
• Chloroquine
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.
• Carboplatin
Administered day 1 of each 21 day cycle for 4-6 cycles.
• Gemcitabine
Administered days 1 and 8 of each 21 day cycle for 4-6 cycles.

Locations
Country Name City State
United States University of Cincinnati Cancer Institute Cincinnati Ohio

Sponsors (1)
Lead Sponsor Collaborator
University of Cincinnati

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Maximum tolerated dose of chloroquine when combined with Carboplatin/Gemcitabine Up to 12 months
Secondary Time to Disease Progression Up to 24 months
Secondary Time of Overall Survival Up to 24 months
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