Extrahepatic Bile Duct CancerPhase 1NCT00003411
Radiation Therapy in Treating Patients With Bile Duct, Gallbladder, or Pancreatic Cancer
A Phase 1 study testing motexafin gadolinium and radiation therapy in people with Extrahepatic Bile Duct Cancer and Gallbladder Cancer, run by University of Pittsburgh at 3 sites in United States.
Trial summary
RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Motexafin gadolinium may increase the effectiveness of radiation therapy by making tumor cells more sensitive to treatment. Read more about this study
- Who is it for?
- Ages 18 to 120 years
- Conditions the study is for
- Extrahepatic Bile Duct Cancer, Gallbladder Cancer, Pancreatic Cancer
- What is being tested?
- motexafin gadolinium and radiation therapy
- Type of treatment
- Surgery or procedure
- How many people
- Not given
- Where
- 3 sitesUnited States
- Study dates
- Nov 1998to Jun 2002
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 120 years
- All sexes
- No healthy volunteers
- Adult, Older adult
DISEASE CHARACTERISTICS: Histologically or cytologically confirmed locally advanced, unresectable carcinoma of the biliary tree or pancreas Metastatic disease allowed on a case by case basis provided the following criteria exists: Minimal or low volume disease Need for palliative radiotherapy to primary tumor with or without motexafin gadolinium No requirement for systemic therapy Measurable disease in at least 2 dimensions No ascites requiring therapy
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 No history of glucose-6-phosphate dehydrogenase deficiency Hepatic: Bilirubin no greater than 2.0 mg/dL AST and ALT less than 3 times upper limit of normal Renal: Creatinine no greater than 1.6 mg/dL Other: Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception No history of porphyria No active infection No physical or psychological illness that would preclude study
PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No concurrent chemotherapy Endocrine therapy: Not specified Radiotherapy: See Disease Characteristics No prior radiotherapy to primary site of tumor Surgery: See Disease Characteristics At least 3 weeks since prior major surgery Other: At least 4 weeks since prior investigational drugs No other concurrent investigational antineoplastic drugs
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Norris Cotton Cancer Center
Lebanon, New Hampshire, 03756-0002
University of Wisconsin Comprehensive Cancer Center
Madison, Wisconsin, 53792-6164
University of Pittsburgh Cancer Institute
Pittsburgh, Pennsylvania, 15213-3489
About this study
Official title: Phase I Dose Escalation and Pharmacokinetics Study of the Radiosensitizer, Gadolinium Texaphyrin (Gd-Tex, NSC 695238) With Concurrent Radiotherapy in Advanced Biliary Tree and Pancreatic Cancers
RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Motexafin gadolinium may increase the effectiveness of radiation therapy by making tumor cells more sensitive to treatment.
PURPOSE: Phase I trial to study the effectiveness of radiation therapy plus motexafin gadolinium in treating patients with bile duct, gallbladder, or pancreatic cancer that cannot be removed surgically.
Read the detailed description
OBJECTIVES: I. Determine the safety and toxicity of motexafin gadolinium (PCI-0120) when administered concurrently with radiotherapy in patients with locally advanced unresectable pancreatic or biliary tree tumors. II. Assess the pharmacokinetics of this regimen in these patients. III. Assess tumor uptake of PCI-0120 (by MRI signal characteristics) in these patients. IV. Determine the maximum tolerated dose of PCI-0120 in these patients. V. Determine the objective response (by radiologic criteria) in patients treated with this regimen.
OUTLINE: This is a multicenter, dose-escalation study of motexafin gadolinium (PCI-0120). Patients receive PCI-0120 IV over 15 minutes 3 times weekly concurrently with external beam radiotherapy (EBRT) 5 days a week for 5.5 weeks. After completion of EBRT and PCI-0120, patients may undergo radiotherapy boost for 5 consecutive days. Cohorts of 3-6 patients receive escalating doses of PCI-0120 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. A total of 6-12 patients are treated at the recommended phase II dose. The recommended phase II dose is defined as the dose immediately preceding the MTD. Patients are followed at 4 weeks.
PROJECTED ACCRUAL: A total of 18-21 patients will be accrued for this study.
- Being tested
- motexafin gadolinium, radiation therapy
- Keywords
- stage II pancreatic cancer, stage III pancreatic cancer, unresectable gallbladder cancer, unresectable extrahepatic bile duct cancer, stage IV pancreatic cancer
- Medical subject headings
- Bile Duct Neoplasms, Gallbladder Neoplasms, Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
motexafin gadoliniumDrug
radiation therapyRadiation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2004 (estimated)
- Study startNov 1998
- Primary completionJun 2002
- Study completionJun 2002
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Extrahepatic Bile Duct CancerStudies of the same condition, open and under way.
- More trials run by University of PittsburghThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
Sponsor and investigators
- Lead sponsor
- University of Pittsburgh
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Principal investigator, Nathan Bahary, MD, University of Pittsburgh
- Investigators
- Ramesh K. Ramanathan, MD, Study chair, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00003411
- Sponsor's protocol ID
- PCI-97-108
- Other IDs
- CDR0000066423, NCI-T97-0109
- Status last verified
- Jan 2016
- First submitted
- 1 Nov 1999
- Last updated
- 18 Jan 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I Dose Escalation and Pharmacokinetics Study of the Radiosensitizer, Gadolinium Texaphyrin (Gd-Tex, NSC 695238) With Concurrent Radiotherapy in Advanced Biliary Tree and Pancreatic Cancers
- ClinicalTrials.gov ID
- NCT00003411
- Acronym / sponsor ID
- PCI-97-108
- Keywords
- stage II pancreatic cancer, stage III pancreatic cancer, unresectable gallbladder cancer, unresectable extrahepatic bile duct cancer, stage IV pancreatic cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- University of PittsburghUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Nov 1998
- Primary completion
- Jun 2002 (actual)
- Study completion
- Jun 2002 (actual)
- First posted
- 20 Feb 2004 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Motexafin gadolinium may increase the effectiveness of radiation therapy by making tumor cells more sensitive to treatment.
PURPOSE: Phase I trial to study the effectiveness of radiation therapy plus motexafin gadolinium in treating patients with bile duct, gallbladder, or pancreatic cancer that cannot be removed surgically.
Detailed description
OBJECTIVES: I. Determine the safety and toxicity of motexafin gadolinium (PCI-0120) when administered concurrently with radiotherapy in patients with locally advanced unresectable pancreatic or biliary tree tumors. II. Assess the pharmacokinetics of this regimen in these patients. III. Assess tumor uptake of PCI-0120 (by MRI signal characteristics) in these patients. IV. Determine the maximum tolerated dose of PCI-0120 in these patients. V. Determine the objective response (by radiologic criteria) in patients treated with this regimen.
OUTLINE: This is a multicenter, dose-escalation study of motexafin gadolinium (PCI-0120). Patients receive PCI-0120 IV over 15 minutes 3 times weekly concurrently with external beam radiotherapy (EBRT) 5 days a week for 5.5 weeks. After completion of EBRT and PCI-0120, patients may undergo radiotherapy boost for 5 consecutive days. Cohorts of 3-6 patients receive escalating doses of PCI-0120 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. A total of 6-12 patients are treated at the recommended phase II dose. The recommended phase II dose is defined as the dose immediately preceding the MTD. Patients are followed at 4 weeks.
PROJECTED ACCRUAL: A total of 18-21 patients will be accrued for this study.
Study design
- Primary purpose
- Treatment
Who may qualify
- Ages
- 18 to 120 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| motexafin gadolinium | Drug | – |
| radiation therapy | Radiation | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jan 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ramesh K. Ramanathan, MD study chair
University of Pittsburgh
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing motexafin gadolinium and radiation therapy in people with Extrahepatic Bile Duct Cancer and Gallbladder Cancer, run by University of Pittsburgh at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Jan 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jan 2016.