Hydroxychloroquine, Carboplatin, Paclitaxel, and Bevacizumab in Recurrent Advanced Non-Small Cell Lung Cancer

This study has been terminated.
(Slow accrual)
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Rutgers, The State University of New Jersey ( University of Medicine and Dentistry of New Jersey )
ClinicalTrials.gov Identifier:
NCT00728845
First received: August 5, 2008
Last updated: September 18, 2013
Last verified: September 2013
Results First Received: September 18, 2013  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Lung Cancer
Interventions: Biological: bevacizumab
Drug: carboplatin
Drug: hydroxychloroquine
Drug: paclitaxel

  Participant Flow
  Hide Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Subjects were recruited from the Cancer Institute of New Jersey (a comprehensive cancer center) and the Robert Wood Johnson University Hospital-Hamilton in New Jersey from January 2009 through December 2010.

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, Carboplatin, Paclitaxel, Bevacizumab Cohort 1: Bevacizumab Eligible Patients All on Day 1 Paclitaxel 200mg/m2 IV over 3 hours Carboplatin AUC= 6 IV over 15-30 min Bevacizumab 15 mg/kg IV over 90 min for PLUS Hydroxychloroquine 200 mg PO BID Cycles every 3 weeks for 4-6 Cycles
Hydroxychloroquine, Carboplatin, Paclitaxel Cohort 2: Bevacizumab Ineligible Patients All on Day 1 Paclitaxel 200mg/m2 IV over 3 hours Carboplatin AUC= 6 IV over 15-30 min PLUS Hydroxychloroquine 200 mg PO BID Cycles every 3 weeks for 4-6 Cycles

Participant Flow:   Overall Study
    Hydroxychloroquine, Carboplatin, Paclitaxel, Bevacizumab     Hydroxychloroquine, Carboplatin, Paclitaxel  
STARTED     8     0  
COMPLETED     8     0  
NOT COMPLETED     0     0  



  Baseline Characteristics
  Hide 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.
No text entered.

Reporting Groups
  Description
Hydroxychloroquine, Carboplatin, Paclitaxel, Bevacizumab Cohort 1: Bevacizumab Eligible Patients All on Day 1 Paclitaxel 200mg/m2 IV over 3 hours Carboplatin AUC= 6 IV over 15-30 min Bevacizumab 15 mg/kg IV over 90 min for PLUS Hydroxychloroquine 200 mg PO BID Cycles every 3 weeks for 4-6 Cycles
Hydroxychloroquine, Carboplatin, Paclitaxel Cohort 2: Bevacizumab Ineligible Patients All on Day 1 Paclitaxel 200mg/m2 IV over 3 hours Carboplatin AUC= 6 IV over 15-30 min PLUS Hydroxychloroquine 200 mg PO BID Cycles every 3 weeks for 4-6 Cycles
Total Total of all reporting groups

Baseline Measures
    Hydroxychloroquine, Carboplatin, Paclitaxel, Bevacizumab     Hydroxychloroquine, Carboplatin, Paclitaxel     Total  
Number of Participants  
[units: participants]
  8     0     8  
Age  
[units: participants]
     
<=18 years     0         0  
Between 18 and 65 years     4         4  
>=65 years     4         4  
Age  
[units: years]
Mean (Standard Deviation)
  63.3  (8.4)         63.3  (8.4)  
Gender  
[units: participants]
     
Female     3         3  
Male     5         5  
Region of Enrollment  
[units: participants]
     
United States     8         8  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Recommended Phase II Dose of Hydroxychloroquine and Carboplatin When Administered With Paclitaxel and Bevacizumab (Phase I)   [ Time Frame: Phase I portion of study ]

2.  Primary:   Overall Response (Phase II)   [ Time Frame: Treatment start date to date of best response ]

3.  Secondary:   Time to Progression (Phase II)   [ Time Frame: Treatment start date and date of progression ]

4.  Secondary:   Progression-free Survival at 1 Year (Phase II)   [ Time Frame: Treatment start date to 1 year ]

5.  Secondary:   Overall Survival (Phase II)   [ Time Frame: Treatment start date to date of death ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
  Hide 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
  Hide More Information

Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Dr. Joseph Aisner
Organization: Cancer Institute of New Jersey
phone: 732-235-8675
e-mail: aisnerjo@cinj.rutgers.edu; rizzoji@cinj.rutgers.edu; zelinsta@cinj.rutgers.edu



Responsible Party: Rutgers, The State University of New Jersey ( University of Medicine and Dentistry of New Jersey )
ClinicalTrials.gov Identifier: NCT00728845     History of Changes
Obsolete Identifiers: NCT00933803
Other Study ID Numbers: CDR0000600241
P30CA072720 ( US NIH Grant/Contract Award Number )
CINJ-030801 ( Other Identifier: CINJ )
Study First Received: August 5, 2008
Results First Received: September 18, 2013
Last Updated: September 18, 2013
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board