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Hydroxychloroquine in Previously Treated Patients With Metastatic Pancreatic Cancer

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ClinicalTrials.gov Identifier: NCT01273805
Recruitment Status : Completed
First Posted : January 11, 2011
Results First Posted : June 14, 2017
Last Update Posted : June 14, 2017
Sponsor:
Collaborators:
Brigham and Women's Hospital
Massachusetts General Hospital
Information provided by (Responsible Party):
Brian Wolpin, MD, MPH, Dana-Farber Cancer Institute

Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Pancreatic Cancer
Intervention: Drug: Hydroxychloroquine

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
20 participants were enrolled between January 2011 and October 2012.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Hydroxychloroquine 400 mg b.i.d. Patients received 400 mg hydroxychloroquine orally twice per day. Cycle duration was 4 weeks. Patients remained on treatment indefinitely without the occurrence of disease progression, unacceptable adverse events, patient withdrawal, or discontinuation per MD decision.
Hydroxychloroquine 600 mg b.i.d. Patients received 600 mg hydroxychloroquine orally twice per day. Cycle duration was 4 weeks. Patients remained on treatment indefinitely without the occurrence of disease progression, unacceptable adverse events, patient withdrawal, or discontinuation per MD decision.

Participant Flow:   Overall Study
    Hydroxychloroquine 400 mg b.i.d.   Hydroxychloroquine 600 mg b.i.d.
STARTED   10   10 
COMPLETED   0   0 
NOT COMPLETED   10   10 
Radiologic PD or Symptom Deterioration                10                10 



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
The analysis dataset is comprised of all enrolled patients.

Reporting Groups
  Description
Hydroxychloroquine 400 mg b.i.d. Patients received 400 mg hydroxychloroquine orally twice per day. Cycle duration was 4 weeks. Patients remained on treatment indefinitely without the occurrence of disease progression, unacceptable adverse events, patient withdrawal, or discontinuation per MD decision.
Hydroxychloroquine 600 mg b.i.d. Patients received 600 mg hydroxychloroquine orally twice per day. Cycle duration was 4 weeks. Patients remained on treatment indefinitely without the occurrence of disease progression, unacceptable adverse events, patient withdrawal, or discontinuation per MD decision.
Total Total of all reporting groups

Baseline Measures
   Hydroxychloroquine 400 mg b.i.d.   Hydroxychloroquine 600 mg b.i.d.   Total 
Overall Participants Analyzed 
[Units: Participants]
 10   10   20 
Age 
[Units: Years]
Median (Full Range)
 67.5 
 (56 to 83) 
 66 
 (58 to 76) 
 67 
 (56 to 83) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      5  50.0%      4  40.0%      9  45.0% 
Male      5  50.0%      6  60.0%      11  55.0% 
Region of Enrollment 
[Units: Participants]
     
United States   10   10   20 
ECOG Performance Status (PS) [1] 
[Units: Participants]
     
PS0   1   1   2 
PS1   5   8   13 
PS2   4   1   5 
[1] ECOG PS0: Fully active, able to carry on all pre-disease performance without restriction ECOG PS1: Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature ECOG PS2: Ambulatory and capable of all self-care but unable to carry out any work activities; Up and about more than 50% of waking hours
Site of Primary Tumor 
[Units: Participants]
     
Head or Head and Body   6   7   13 
Body or Tail   4   3   7 
Location of Metastasis 
[Units: Participants]
     
Liver   8   7   15 
Lung   4   3   7 
Peritoneum   4   5   9 
Other   2   2   4 


  Outcome Measures

1.  Primary:   2-month Progression-Free Survival Rate   [ Time Frame: Disease was evaluated radiologically at baseline and at the first restaging at 2 months. ]

2.  Secondary:   Biochemical Response Rate   [ Time Frame: Disease was evaluated radiologically at baseline and every 2 months on treatment. Median duration of treatment for this study cohort was 34 days. ]

3.  Secondary:   Tumor Response Rate   [ Time Frame: Disease was evaluated radiologically at baseline and every 2 months on treatment. Median duration of treatment for this study cohort was 34 days. ]

4.  Secondary:   Overall Survival   [ Time Frame: All patients were followed until death. Median survival follow-up in this study cohort was 60 days (95% CI: 40-184). ]

5.  Secondary:   Progression-Free Survival   [ Time Frame: Disease was evaluated radiologically at baseline and every 2 months on treatment. Median PFS follow-up in this study cohort was 46.5 days (95% CI 33-61). ]

6.  Secondary:   Grade 4-5 Treatment-Related Toxicity   [ Time Frame: Adverse events were assessed each cycle throughout treatment. Participants were followed for the duration of treatment, an average of 34 days for this study population. ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information

Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Brian M. Wolpin
Organization: Dana-Farber Cancer Institute
phone: 617.632.6942
e-mail: Brian_Wolpin@dfci.harvard.edu


Publications of Results:

Responsible Party: Brian Wolpin, MD, MPH, Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier: NCT01273805     History of Changes
Other Study ID Numbers: 10-310
First Submitted: January 7, 2011
First Posted: January 11, 2011
Results First Submitted: April 11, 2017
Results First Posted: June 14, 2017
Last Update Posted: June 14, 2017