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A Phase I/II Clinical Trial of Intravenous (IV) Calcitriol With Fixed Dose of Cisplatin and Docetaxel in Advanced Non-Small Cell Lung Cancer

Phase 1/Phase 2
18 Years
Open (Enrolling)
Non Small Cell Lung Cancer

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Trial Information

A Phase I/II Clinical Trial of Intravenous (IV) Calcitriol With Fixed Dose of Cisplatin and Docetaxel in Advanced Non-Small Cell Lung Cancer

Inclusion Criteria:

1. Proven histological or cytological diagnosis of stage IIIB (malignant pleural
effusion) IV NSCLC.

2. Age more than 18 years

3. Performance status must be ECOG 0-1.

4. No prior or concurrent malignancy, except non-melanoma skin cancer, or CIS of the
cervix, unless documented disease-free for more than 2 years.

5. No prior use of chemotherapy for stage IV NSCLC; Adjuvant therapy is permitted.

6. Adequate bone marrow, hepatic, and renal function, as evidenced by the following: WBC
3.0 x 109/L, neutrophils 1.5 x 109 /L; platelet count 100 x 109/L; Hgb> 10 g/dL (may
be transfused to 10g/dL); total bilirubin within the upper limit of the institutional
normal range; (transaminases SGOT or SGPT) 1.5 times the upper limit of the
institutional normal range. Creatinine within the upper limit of the institutional
normal range; creatinine clearance >50 ml/min

7. Patients must have measurable or evaluable disease (not required for the phase I part
of the study)

8. Normal cardiac function with no history of uncontrolled heart disease

9. Female patients must not be pregnant; they must be post-menopausal or practicing an
accepted form of birth control. If pregnancy is a possibility, a pregnancy test will
be required prior to initiation of therapy.

10. Life expectancy of at least 12 weeks.

11. Patient and investigator signed study-specific consent form, indicating the
investigational nature of the study

12. Patients must be accessible for treatment and follow-up.

13. No chemotherapy or radiotherapy within 3 weeks of study entry defined here as day 1
of therapy with calcitriol plus chemotherapy (6 weeks for mitomycin C or a

14. No treatment with investigational drugs within 3 weeks of study entry.

15. No other serious illness or medical condition including unstable cardiac disease
requiring treatment, new onset crescendo or rest angina; history of significant
neurological or psychiatric disorders including psychotic disorders, dementia, or
seizures; or active infection are permitted. No evidence of grade > 2 peripheral
neuropathy. No history of severe hypersensitivity reaction to docetaxel or other
drugs formulated with polysorbate 80

16. Palliative radiation is permitted (as long as marrow exposed not greater than 10%;
please see Appendix IV for reference) At least 1 week since the last palliative XRT.

17. Treated brain metastasis allowed with no waiting period following gamma knife and at
least 2 weeks after whole brain XRT as long as neurologically stable.

Exclusion Criteria:

1. Known hypersensitivity to Vitamin D, docetaxel, cisplatin

2. Hypercalcemia (patients with serum albumin corrected calcium* > 10.7 mg/dL)

3. History of renal/bladder stones over the past 10 years

4. History of nephrectomy.

5. Uncontrolled heart disease, unstable angina, heart failure, current digoxin therapy

6. Thiazide, Digoxin or glucocorticoid therapy (except the pre-medication Dexamethasone
used in the study as prescribed)

7. Unwillingness to stop calcium supplementation

8. Concurrent use of Phenytoin, Barbiturates, Rifampin, Carbamazepine, Phenobarbital or
St John's wort.

9. Treatment with any investigational drug within 3 weeks before Day 1 of protocol

10. Any unresolved toxicity (NCI CTCAE version 3.0,>2) (Please see appendix V for link)

11. Pregnancy/Lactation

12. Patients with IIIB NSCLC who are eligible for definitive chemoradiation.

- Ca corrected = Ca (measured) + (0.8 x (4 - albumin))

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

To conduct a phase I and phase II study to determine the MTD and the DLT 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)

Outcome Description:

An interim analysis will be conducted to determine if this investigation should be expanded to a phase II study.

Outcome Time Frame:

3-6 months

Safety Issue:


Principal Investigator

Nithya Ramnath, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Michigan Cancer Center


United States: Institutional Review Board

Study ID:

UMCC 2008.042



Start Date:

December 2008

Completion Date:

January 2015

Related Keywords:

  • Non Small Cell Lung Cancer
  • lung cancer; nsclc
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms



Roswell Park Cancer Institute Buffalo, New York  14263
University of Michigan Comprehensive Cancer Center Ann Arbor, Michigan  48109-0752
St. Joseph Mercy Hospital Pontiac, Michigan  48341-2985
VA Ann Arbor Healthcare System Ann Arbor, Michigan  48113