Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Trial Contact Information
Registry Information

Alternate Title

Calcitriol Plus Paclitaxel in Treating Patients With Advanced Solid Tumors

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase I	Treatment	Completed	18 and over	NCI	PCI-98019 PCI-IRB-980542, NCI-G00-1901, NCT00009802

Objectives

1. Determine the toxic effects and maximum tolerated dose of calcitriol when combined with paclitaxel in patients with advanced solid tumors.
2. Determine the effect of administration of calcitriol on the pharmacokinetics of paclitaxel in these patients.
3. Determine the effect of administration of paclitaxel on the pharmacokinetics of calcitriol in these patients.

Entry Criteria

Disease Characteristics:

• Histologically proven advanced cancer not curable by standard therapies



• Brain metastases allowed following definitive radiotherapy

Prior/Concurrent Therapy:

Biologic therapy:

• At least 3 weeks since prior regional or systemic biologic therapy

Chemotherapy:

• At least 3 weeks since prior chemotherapy (6 weeks for mitomycin or nitrosourea)

Endocrine therapy:

• Not specified

Radiotherapy:

• See Disease Characteristics
• At least 3 weeks since prior radiotherapy

Surgery:

• Not specified

Patient Characteristics:

Age:

• 18 and over

Performance status:

• ECOG 0-2

Life expectancy:

• Not specified

Hematopoietic:

• Absolute neutrophil count at least 1,500/mm³
• Platelet count at least 100,000/mm³

Hepatic:

• Bilirubin no greater than 1.5 mg/dL
• SGOT no greater than 4 times normal

Renal:

• Creatinine no greater than 2.0 mg/dL
• Calcium no greater than 10.5 mg/dL

Other:

• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective double-barrier contraception for at least 1 week before, during, and for at least 2 weeks after study
• No active infection or serious concurrent condition
• No symptomatic peripheral neuropathy greater than grade 1

Expected Enrollment

A total of 60 patients will be accrued for this study.

Outline

This is a dose-escalation study of calcitriol.

During course 1, patients receive oral calcitriol daily on days 1-3 of weeks 1-6 and paclitaxel IV over 1 hour on day 1 of week 1 and day 3 of weeks 2-6. During course 2 and subsequent courses, patients receive oral calcitriol daily on days 1-3 and paclitaxel IV over 1 hour on day 3 of weeks 1-6. Treatment continues every 8 weeks in the absence of disease progression or unacceptable toxicity.

Cohorts of 3-6 patients receive escalating doses of calcitriol until the maximum tolerated dose (MTD) is determined. The MTD is defined as the highest dose giving an estimated probability of dose-limiting toxicity of no more than 0.30.

Trial Contact Information

Trial Lead Organizations

UPMC Cancer Centers

Ramesh Ramanathan, MD, Protocol chair		Ph: 412-648-6507

Registry Information
Official Title		A Phase I Trial Of Oral Calcitriol [1,25-(OH)2D3] And Paclitaxel In Advanced Solid Tumors
Trial Start Date		1998-06-03
Registered in ClinicalTrials.gov		NCT00009802
Date Submitted to PDQ		2000-12-05
Information Last Verified		2003-12-08
NCI Grant/Contract Number		P30-CA47904

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