Phase I/II Calcitriol in Lung Cancer

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Nithya Ramnath, MD, University of Michigan Cancer Center
ClinicalTrials.gov Identifier:
NCT00794547
First received: November 19, 2008
Last updated: March 31, 2014
Last verified: March 2014
Results First Received: March 31, 2014  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Non Small Cell Lung Cancer
Intervention: Drug: Calcitriol

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

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
Phase 1

In the Phase I part of the study, we will test the safety of calcitriol along with standard chemotherapy. In addition, the goal is to see what effects (good and bad) it has on you and your type of Non-Small Cell Lung Cancer. This study is ongoing. In this portion of the study, we are testing increasing doses of calcitriol in combination with standard chemotherapy. If 2/3 patients at any dose level experience side effects that are limiting, we will call the dose level below that dose the maximum tolerated dose.

Calcitriol: Escalating dose of Calcitriol will be infused IV over 1 hour every 21 days.

Phase 2

In the Phase II part of the study, we will find out the response of subjects' cancer has to the combination of a fixed dose of calcitriol (determined in the phase I study) with standard chemotherapy.

Calcitriol: In this portion of the study, all patients will get the same dose of calcitriol (determined from the Phase I study) along with the standard chemotherapy


Participant Flow:   Overall Study
    Phase 1     Phase 2  
STARTED     18     16  
COMPLETED     18     16  
NOT COMPLETED     0     0  



  Baseline Characteristics
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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.
Thirty-four patients were enrolled (18 in phase I and 16 in phase II).

Reporting Groups
  Description
Calcitriol + Cisplatin + Docetaxel Calcitriol, administered IV at 30, 45, 60, 80, or 100 mcg/m^2 (every 21 days), along with Cisplatin, 75 mg/m^2 (every three weeks), and Docetaxel, 75 mg/m^2 (every three weeks).

Baseline Measures
    Calcitriol + Cisplatin + Docetaxel  
Number of Participants  
[units: participants]
  34  
Age  
[units: years]
Median ( Full Range )
  54  
  ( 34 to 79 )  
Gender  
[units: participants]
 
Female     22  
Male     12  
Region of Enrollment  
[units: participants]
 
United States     34  
Histology [1]
[units: participants]
 
Adenocarcinoma     21  
Squamous carcinoma     12  
NSCLC NOS     1  
Performance Status [2]
[units: participants]
 
Performance Status 0     16  
Performance Status 1     18  
Smoking Status  
[units: participants]
 
Never Smoker     2  
Ever Smoker     29  
Unknown     3  
[1] Tumor histology results. Categories include Adenocarcinoma, Squamous Carcinoma and Non-Small-Cell Lung Cancer Not Otherwise Specified (NSCLC NOS).
[2] Eastern Cooperative Oncology Group Performance Status at baseline. Scores may be 0 (Asymptomatic; fully active, able to carry on all predisease activities without restriction) or 1 (Symptomatic but completely ambulatory; restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature. For example, light housework, office work)



  Outcome Measures
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1.  Primary:   MTD of Intravenous Calcitriol When Administered Prior to Fixed Dose Cisplatin 75mg/m2 and Docetaxel 75 mg/m2, Every 3 Weeks in Patients With Advanced Non-small Cell Lung Cancer (NSCLC)   [ Time Frame: 5 years ]

2.  Primary:   Number of Participants That Experience Grade 3 or Greater Neutropenia   [ Time Frame: 30 days after last dose ]

3.  Primary:   Median Time to Progression   [ Time Frame: 5 years ]

4.  Primary:   Median Overall Survival   [ Time Frame: 5 years ]

5.  Secondary:   To Assess Pharmacokinetics (PK) of Intravenous (IV) Calcitriol in Combination With Cisplatin and Docetaxel During Cycle 1 of the Phase II Part of the Study Using a Validated Limited Sampling Technique.   [ Time Frame: 3-6 months ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   Yes

6.  Secondary:   To Correlate the Pharmacokinetic Parameters of Systemic Calcitriol Exposure (AUC) With SNPs of the 24-hydroxylase (CYP24), the Major Vitamin D3 Inactivating Enzyme.   [ Time Frame: 3-6 months ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   Yes


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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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
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  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Dr. Nithya Ramnath
Organization: University of Michigan Comprehensive Cancer Center
phone: 734-647-1417
e-mail: nithyar@umich.edu


Publications of Results:

Responsible Party: Nithya Ramnath, MD, University of Michigan Cancer Center
ClinicalTrials.gov Identifier: NCT00794547     History of Changes
Obsolete Identifiers: NCT00470431
Other Study ID Numbers: UMCC 2008.042, HUM 21242
Study First Received: November 19, 2008
Results First Received: March 31, 2014
Last Updated: March 31, 2014
Health Authority: United States: Institutional Review Board