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Calcitriol Plus Paclitaxel in Treating Patients With Advanced Solid Tumors

NCT ID: NCT00009802

Last Updated: 2013-12-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

45 participants

Study Classification

INTERVENTIONAL

Study Start Date

1998-06-30

Study Completion Date

2005-06-30

Brief Summary

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RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Calcitriol may increase the effectiveness of paclitaxel by making tumor cells more sensitive to the drug.

PURPOSE: Phase I trial to study the effectiveness of combining calcitriol with paclitaxel in treating patients who have advanced solid tumors.

Detailed Description

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OBJECTIVES:

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

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.

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

Conditions

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Unspecified Adult Solid Tumor, Protocol Specific

Keywords

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unspecified adult solid tumor, protocol specific

Study Design

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Primary Study Purpose

TREATMENT

Interventions

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calcitriol

Intervention Type DIETARY_SUPPLEMENT

paclitaxel

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

DISEASE CHARACTERISTICS:

* Histologically proven advanced cancer not curable by standard therapies
* Brain metastases allowed following definitive radiotherapy

PATIENT CHARACTERISTICS:

Age:

* 18 and over

Performance status:

* ECOG 0-2

Life expectancy:

* Not specified

Hematopoietic:

* Absolute neutrophil count at least 1,500/mm\^3
* Platelet count at least 100,000/mm\^3

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

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Cancer Institute (NCI)

NIH

Sponsor Role collaborator

University of Pittsburgh

OTHER

Sponsor Role lead

Responsible Party

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Laura A. Pollice

Clinical Research Manager

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Ramesh K. Ramanathan, MD

Role: STUDY_CHAIR

University of Pittsburgh

Locations

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University of Pittsburgh Cancer Institute

Pittsburgh, Pennsylvania, United States

Site Status

Countries

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United States

Other Identifiers

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CDR0000068411

Identifier Type: REGISTRY

Identifier Source: secondary_id

PCI-IRB-980542

Identifier Type: -

Identifier Source: secondary_id

NCI-G00-1901

Identifier Type: -

Identifier Source: secondary_id

98-019

Identifier Type: -

Identifier Source: org_study_id