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Completed

NCT Number: NCT02071537

Chloroquine in Combination With Carboplatin/Gemcitabine in Advanced Solid Tumors

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.

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Key information

Conditions

Malignant Neoplasm Neoplasms Solid Tumors

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

University of Cincinnati Cancer Institute

Cincinnati, Ohio, 45267-0502, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Chloroquine

Drug

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.

Other names: Chloroquine Phosphate, Aralen

carboplatin

Drug

Administered day 1 of each 21 day cycle for 4-6 cycles.

Other names: Paraplatin, CBDCA

Gemcitabine

Drug

Administered days 1 and 8 of each 21 day cycle for 4-6 cycles.

Other names: Gemzar

Primary outcomes

  1. Maximum tolerated dose of chloroquine when combined with Carboplatin/Gemcitabine

    Time frame: Up to 12 months

Secondary outcomes

  1. Time to Disease Progression

    Time frame: Up to 24 months

  2. Time of Overall Survival

    Time frame: Up to 24 months

Sponsors and collaborators

Lead sponsor

University of Cincinnati

Other

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2018
Study completion
2018
First posted
Feb 26, 2014
Registry last updated
Nov 25, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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