NCT00003798

Brief Summary

RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Drugs such as gadolinium texaphyrin may make the tumor cells more sensitive to radiation therapy. PURPOSE: Phase I trial to study the effectiveness of gadolinium texaphyrin plus radiation therapy in treating patients who have cancer of the pancreas that cannot be removed by surgery.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
45

participants targeted

Target at P50-P75 for phase_1 pancreatic-cancer

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 1, 1999

Completed
5 months until next milestone

Study Start

First participant enrolled

April 1, 2000

Completed
4.3 years until next milestone

First Posted

Study publicly available on registry

August 4, 2004

Completed
Last Updated

November 14, 2012

Status Verified

November 1, 2012

First QC Date

November 1, 1999

Last Update Submit

November 13, 2012

Conditions

Pancreatic Cancer

Keywords

stage II pancreatic cancerstage III pancreatic canceradenocarcinoma of the pancreas

Interventions

motexafin gadoliniumDRUG
radiation therapyRADIATION

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
DISEASE CHARACTERISTICS: Histologically confirmed locally advanced, unresectable pancreatic or periampullary adenocarcinoma Patients may have evidence of hepatic or other intra-abdominal or systemic metastases if they have dominant symptomatology from the locally unresectable component of disease Prior treatment with 1 chemotherapy regimen required Palliative bypass procedures without resection allowed Bidimensionally measurable disease on CT or MRI scan PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Karnofsky 60-100% Life expectancy: Not specified Hematopoietic: WBC at least 3,000/mm3 Absolute neutrophil count at least 1,500/mm3 Platelet count at least 150,000/mm3 Hemoglobin at least 8.5 g/dL No history of G6PD deficiency Hepatic: SGOT or SGPT less than 2 times upper limit of normal (ULN) Alkaline phosphatase less than 2 times ULN Bilirubin no greater than 2.0 mg/dL (elevated values must be falling or stable for at least 1 week prior to therapy) Renal: Creatinine no greater than 2.0 mg/dL (no clinical indication of compromised kidney) Other: Not pregnant or nursing Fertile patients must use effective contraception No second malignancy within the past 5 years, except: Resected superficial nonmelanomatous skin cancer Carcinoma in situ of the cervix No uncontrolled or serious medical conditions No active peptic ulcers No weight loss greater than 5% of ideal body weight within 30 days prior to study No uncontrolled nausea and vomiting No claustrophobia PRIOR CONCURRENT THERAPY: Biologic therapy: At least 4 weeks since prior biologic therapy No concurrent experimental biologic therapy Chemotherapy: See Disease Characteristics Endocrine therapy: Not specified Radiotherapy: No prior radiotherapy compromising the delivery of radiation on this study No prior radiotherapy to areas within the planned field of treatment Surgery: At least 4 weeks since prior gastrointestinal surgery Other: At least 4 weeks since prior experimental drugs No other concurrent experimental drugs

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

Johns Hopkins Oncology Center

Baltimore, Maryland, 21287, United States

Location

MeSH Terms

Conditions

Pancreatic Neoplasms

Interventions

motexafin gadoliniumRadiotherapy

Condition Hierarchy (Ancestors)

Digestive System NeoplasmsNeoplasms by SiteNeoplasmsEndocrine Gland NeoplasmsDigestive System DiseasesPancreatic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

  • Ross A. Abrams, MD

    Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 1
Purpose
TREATMENT
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 1, 1999

First Posted

August 4, 2004

Study Start

April 1, 2000

Last Updated

November 14, 2012

Record last verified: 2012-11

Locations

US(1)