Gastric CancerPhase 1NCT00003157
Radiation Therapy and Chemotherapy in Treating Patients With Cancer of the Pancreas or Stomach
A Phase 1 study testing cisplatin, gemcitabine hydrochloride and radiation therapy in people with Gastric Cancer and Pancreatic Cancer, run by Alliance for Clinical Trials in Oncology at 18 sites in United States.
Trial summary
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Combining radiation therapy with chemotherapy may kill more tumor cells. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gastric Cancer, Pancreatic Cancer
- What is being tested?
- cisplatin, gemcitabine hydrochloride and radiation therapy
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 18 sitesUnited States
- Study dates
- Feb 1998to May 2003
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
DISEASE CHARACTERISTICS: Histologically proven unresectable (including incomplete resections) or locally recurrent pancreatic or gastric cancer No evidence of metastases outside of the planned radiation field No cystadenocarcinoma of the pancreas or pancreatic tumors of neuroendocrine origin
PATIENT CHARACTERISTICS: Age: 18 and over Performance Status: ECOG 0-1 Life Expectancy: Not specified Hematopoietic: Absolute neutrophil count at least 2,000/mm3 Platelet count at least 100,000/mm3 Hepatic: Bilirubin within normal limits Alkaline phosphatase no greater than 3.0 times upper limit of normal (ULN) AST no greater than 3.0 times ULN Renal: Creatinine no greater than 1.3 times ULN Other: Not pregnant or nursing Fertile patients must use effective contraception No significant infection or medical illness No significant nausea or vomiting At least 1200 calories per day of oral nutrition
PRIOR CONCURRENT THERAPY: Biologic therapy: No prior or concurrent biologic therapy Chemotherapy: No prior or concurrent chemotherapy Endocrine therapy: Not specified Radiotherapy: No prior radiotherapy (except focal fields for skin cancer that do not overlap with planned radiotherapy fields) Surgery: At least 21 days since laparotomy surgery
Trial locations and contacts
18 sites in 1 country.
18 sites in 1 country
United States18 sites
Medcenter One Health System
Bismarck, North Dakota, 58501
CCOP - Cedar Rapids Oncology Project
Cedar Rapids, Iowa, 52403-1206
CCOP - Geisinger Clinic and Medical Center
Danville, Pennsylvania, 17822-2001
CCOP - Iowa Oncology Research Association
Des Moines, Iowa, 50309-1016
CCOP - Duluth
Duluth, Minnesota, 55805
Altru Health Systems
Grand Forks, North Dakota, 58201
CCOP - Missouri Valley Cancer Consortium
Omaha, Nebraska, 68131
CCOP - Illinois Oncology Research Association
Peoria, Illinois, 61602
Rapid City Regional Hospital
Rapid City, South Dakota, 57709
Mayo Clinic Cancer Center
Rochester, Minnesota, 55905
CentraCare Clinic
Saint Cloud, Minnesota, 56303
CCOP - Metro-Minnesota
Saint Louis Park, Minnesota, 55416
CCOP - Scottsdale Oncology Program
Scottsdale, Arizona, 85259-5404
Siouxland Hematology-Oncology
Sioux City, Iowa, 51101-1733
CCOP - Sioux Community Cancer Consortium
Sioux Falls, South Dakota, 57105-1080
CCOP - Toledo Community Hospital Oncology Program
Toledo, Ohio, 43623-3456
CCOP - Carle Cancer Center
Urbana, Illinois, 61801
CCOP - Wichita
Wichita, Kansas, 67214-3882
About this study
Official title: A Phase I Study of Gemcitabine, Cisplatin, and Radiation Therapy in Patients With Locally Advanced Pancreatic and Gastric Cancer
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Combining radiation therapy with chemotherapy may kill more tumor cells.
PURPOSE: Phase I trial to study the effectiveness of radiation therapy plus chemotherapy in treating patients who have cancer of the pancreas or stomach.
Read the detailed description
OBJECTIVES: I. Determine the maximum tolerated dose of gemcitabine and cisplatin that can be administered during a standard course of radiation therapy for patients with unresectable or locally recurrent pancreatic and gastric cancer. II. Describe the tolerance of gemcitabine, cisplatin, and radiation therapy in this patient population. III. Seek preliminary evidence of the therapeutic activity of this regimen in this patient population as measured by survival.
OUTLINE: This is a dose escalation study. Patients undergo radiotherapy to the tumor and lymph nodes, followed by a decrease in radiotherapy to the tumor alone. Radiation therapy is administered for a total of 5.5 weeks. Patients receive intravenous gemcitabine twice weekly on Tuesday and Friday over the first 3 weeks of radiotherapy. Cisplatin is administered intravenously twice weekly following gemcitabine therapy. Three patients are treated at each dose level. Dose escalation does not occur until all patients at a given dose level have completed radiotherapy and returned for a 4 week follow up. The dose limiting toxicity (DLT) is defined as the dose at which at least 2 of 6 patients experience unacceptable toxic effects. The maximum tolerated dose is defined as the dose at which no more than 1 of 6 patients experiences DLT. Patients exhibiting stable disease remain on therapy until disease progression or intolerable toxic effects. Patients experiencing toxic effects and no disease progression are retreated at a lower dose. Patients are followed every 3 months for the first 2 years then every 6 months for the next year.
- Conditions
- Gastric Cancer, Pancreatic Cancer
- Being tested
- cisplatin, gemcitabine hydrochloride, radiation therapy
- Keywords
- stage IV gastric cancer, recurrent gastric cancer, recurrent pancreatic cancer, stage IV pancreatic cancer
- Medical subject headings
- Stomach Neoplasms, Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cisplatinDrug
radiation therapyRadiation
| Study group | Role | What they receive |
|---|---|---|
| radiation + gemcitabine + cisplatin | Experimental | Patients undergo radiotherapy to the tumor and lymph nodes, followed by a decrease in radiotherapy to the tumor alone. Radiation therapy is administered for a total of 5.5 weeks. Patients receive intravenous gemcitabine twice weekly over the first 3 weeks of radiotherapy. Cisplatin is administered intravenously twice weekly following gemcitabine therapy. Three patients are treated at each dose level. Dose escalation does not occur until all patients at a given dose level have completed radiotherapy and returned for a 4 week follow up. Patients exhibiting stable disease remain on therapy until disease progression or intolerable toxic effects. Patients experiencing toxic effects and no disease progression are retreated at a lower dose. Patients are followed every 3 months for the first 2 years then every 6 months for the next year. Receives: Drug: cisplatin; Drug: gemcitabine hydrochloride; Radiation: radiation therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum tolerated dose
Measured: Up to 3 years
Secondary outcomes (1)
Survival
Measured: Up to 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2004 (estimated)
- Study startFeb 1998
- Primary completionMay 2003
- Study completionMay 2003
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Gastric CancerStudies of the same condition, open and under way.
- More trials run by Alliance for Clinical Trials in OncologyThe 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
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alliance for Clinical Trials in Oncology
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- James A. Martenson, MD, Study chair, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00003157
- Sponsor's protocol ID
- NCCTG-964352
- Other IDs
- CDR0000065949
- Status last verified
- Jul 2016
- First submitted
- 1 Nov 1999
- Last updated
- 14 Jul 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Martenson JA Jr, Viglitotti AG, Geeraerts LH, et al.: Phase I study of twice weekly gemcitabine (GEM) and cisplatin (CDDP) during radiation therapy (RT) for advanced pancreas and gastric cancer: a progress report. [Abstract] Proceedings of the American Society of Clinical Oncology A-2305, 2001.
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Study of Gemcitabine, Cisplatin, and Radiation Therapy in Patients With Locally Advanced Pancreatic and Gastric Cancer
- ClinicalTrials.gov ID
- NCT00003157
- Acronym / sponsor ID
- NCCTG-964352
- Conditions
- Gastric Cancer, Pancreatic Cancer
- Keywords
- stage IV gastric cancer, recurrent gastric cancer, recurrent pancreatic cancer, stage IV pancreatic cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Alliance for Clinical Trials in OncologyUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Feb 1998
- Primary completion
- May 2003 (actual)
- Study completion
- May 2003 (actual)
- First posted
- 30 Mar 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: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Combining radiation therapy with chemotherapy may kill more tumor cells.
PURPOSE: Phase I trial to study the effectiveness of radiation therapy plus chemotherapy in treating patients who have cancer of the pancreas or stomach.
Detailed description
OBJECTIVES: I. Determine the maximum tolerated dose of gemcitabine and cisplatin that can be administered during a standard course of radiation therapy for patients with unresectable or locally recurrent pancreatic and gastric cancer. II. Describe the tolerance of gemcitabine, cisplatin, and radiation therapy in this patient population. III. Seek preliminary evidence of the therapeutic activity of this regimen in this patient population as measured by survival.
OUTLINE: This is a dose escalation study. Patients undergo radiotherapy to the tumor and lymph nodes, followed by a decrease in radiotherapy to the tumor alone. Radiation therapy is administered for a total of 5.5 weeks. Patients receive intravenous gemcitabine twice weekly on Tuesday and Friday over the first 3 weeks of radiotherapy. Cisplatin is administered intravenously twice weekly following gemcitabine therapy. Three patients are treated at each dose level. Dose escalation does not occur until all patients at a given dose level have completed radiotherapy and returned for a 4 week follow up. The dose limiting toxicity (DLT) is defined as the dose at which at least 2 of 6 patients experience unacceptable toxic effects. The maximum tolerated dose is defined as the dose at which no more than 1 of 6 patients experiences DLT. Patients exhibiting stable disease remain on therapy until disease progression or intolerable toxic effects. Patients experiencing toxic effects and no disease progression are retreated at a lower dose. Patients are followed every 3 months for the first 2 years then every 6 months for the next year.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| radiation + gemcitabine + cisplatin | Experimental | Drug: cisplatin, Drug: gemcitabine hydrochloride, Radiation: radiation therapyPatients undergo radiotherapy to the tumor and lymph nodes, followed by a decrease in radiotherapy to the tumor alone. Radiation therapy is administered for a total of 5.5 weeks. Patients receive intravenous gemcitabine twice weekly over the first 3 weeks of radiotherapy. Cisplatin is administered intravenously twice weekly following gemcitabine therapy. Three patients are treated at each dose level. Dose escalation does not occur until all patients at a given dose level have completed radiotherapy and returned for a 4 week follow up. Patients exhibiting stable disease remain on therapy until disease progression or intolerable toxic effects. Patients experiencing toxic effects and no disease progression are retreated at a lower dose. Patients are followed every 3 months for the first 2 years then every 6 months for the next year. |
Who may qualify
- Ages
- 18 years and older
- 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 |
|---|---|---|
| cisplatin | Drug | radiation + gemcitabine + cisplatin |
| gemcitabine hydrochloride | Drug | radiation + gemcitabine + cisplatin |
| radiation therapy | Radiation | radiation + gemcitabine + cisplatin |
Primary outcome
Maximum tolerated dose
Time frame: Up to 3 years
1 secondary outcome
Survival
Time frame: Up to 3 years
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 14 Jul 2016.
- Results publicationMartenson JA Jr, Viglitotti AG, Geeraerts LH, et al.: Phase I study of twice weekly gemcitabine (GEM) and cisplatin (CDDP) during radiation therapy (RT) for advanced pancreas and gastric cancer: a progress report. [Abstract] Proceedings of the American Society of Clinical Oncology A-2305, 2001.
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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.
James A. Martenson, MD study chair
Mayo Clinic
18 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 cisplatin, gemcitabine hydrochloride and radiation therapy in people with Gastric Cancer and Pancreatic Cancer, run by Alliance for Clinical Trials in Oncology at 18 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 14 Jul 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 18 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.
What does the primary outcome measure?
Maximum tolerated dose (time frame: Up to 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00003157, which also lists 1 linked publication.
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 14 Jul 2016.