Radiation Therapy Plus Gadolinium Texaphyrin in Treating Patients With Cancer of the Pancreas That Cannot Be Removed by Surgery

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00003798
Recruitment Status : Completed
First Posted : August 4, 2004
Last Update Posted : November 14, 2012
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

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.

Condition or disease Intervention/treatment Phase
Pancreatic Cancer Drug: motexafin gadolinium Radiation: radiation therapy Phase 1

Detailed Description:

OBJECTIVES: I. Determine the maximum tolerated dose of gadolinium texaphyrin in patients with locally advanced, unresectable pancreatic or periampullary adenocarcinoma undergoing local regional radiotherapy. II. Determine the toxic effects of gadolinium texaphyrin with concurrent radiotherapy in these patients. III. Correlate estimates of tumor and normal organ gadolinium texaphyrin uptake and retention over time by MRI with plasma/serum levels in these patients.

OUTLINE: This is a dose escalation study. Patients receive gadolinium texaphyrin IV over 5-10 minutes 4 times weekly at least 2 hours prior to external beam radiotherapy over 2.5 weeks (total of 10 fractions). Cohorts of 3-6 patients are treated at escalating doses of gadolinium texaphyrin. The maximum tolerated dose is defined as the highest dose level in which dose limiting toxicity occurs in no more than 2 of 6 patients. Patients are followed once monthly for 2 months.

PROJECTED ACCRUAL: A total of 45 evaluable patients will be accrued for this study within 18-24 months.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 45 participants
Primary Purpose: Treatment
Official Title: Phase I Study Involving Gadolinium Texaphyrin (NSC 695238) in Patients With Pancreatic and Periampullary Adenocarcinoma Receiving Radiotherapy for Unresectable Disease
Study Start Date : April 2000

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00003798

United States, Maryland
Johns Hopkins Oncology Center
Baltimore, Maryland, United States, 21287
Sponsors and Collaborators
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
National Cancer Institute (NCI)
Study Chair: Ross A. Abrams, MD Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Responsible Party: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins Identifier: NCT00003798     History of Changes
Other Study ID Numbers: CDR0000066941, J9840
P30CA006973 ( U.S. NIH Grant/Contract )
First Posted: August 4, 2004    Key Record Dates
Last Update Posted: November 14, 2012
Last Verified: November 2012

Keywords provided by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins:
stage II pancreatic cancer
stage III pancreatic cancer
adenocarcinoma of the pancreas

Additional relevant MeSH terms:
Pancreatic Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases
Motexafin gadolinium
Antineoplastic Agents
Photosensitizing Agents
Dermatologic Agents