Pancreatic CancerPhase 1/2NCT01017822
Conatumumab, Gemcitabine Hydrochloride, Capecitabine, and Radiation Therapy in Treating Patients With Locally Advanced Pancreatic Cancer
A Phase 1/2 study testing conatumumab, capecitabine and gemcitabine hydrochloride in people with Pancreatic Cancer, run by Radiation Therapy Oncology Group.
Trial summary
RATIONALE: Monoclonal antibodies, such as conatumumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pancreatic Cancer
- What is being tested?
- conatumumab, capecitabine and gemcitabine hydrochloride
- Type of treatment
- Surgery or procedure
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Start not givento not given
- Phase
- Phase 1/2
- 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 or cytologically confirmed adenocarcinoma of the pancreas
- Locally advanced disease
- With and without regional adenopathy
- Unresectable disease based on institutional standardized criteria of unresectability OR medically inoperable
- No distant metastatic disease, second malignancy, or peritoneal seeding
PATIENT CHARACTERISTICS:
- Zubrod performance status 0-1
- Absolute granulocyte count ≥ 1,500/mm³
- Platelet count ≥ 100,000/mm³
- Hemoglobin ≥ 8.0 g/dL (transfusion or other intervention allowed)
- Serum creatinine ≤ 1.5 mg/dL
- ALT or AST < 3 times upper limit of normal (ULN)
- Total bilirubin < 3.0 mg/dL
- Alkaline phosphatase < 3 times ULN
- Amylase ≤ 2 times ULN
- Lipase ≤ 2 times ULN
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception during and for ≥ 3 months after the last study drug administration (for women) or for ≥ 6 months after the last study drug administration (for men)
- Able to swallow oral medications
- No other invasive malignancy within the past 2 years, except for nonmelanomatous skin cancer or carcinoma in situ of the breast, oral cavity, or cervix
- No severe, active co-morbidity, including any of the following:
- Chronic obstructive pulmonary disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy within the past 30 days
- Transmural myocardial infarction within the past 3 months
- Unstable angina and/or congestive heart failure requiring hospitalization within the past 6 months
- Any other cardiac condition that, in the opinion of the treating physician, would make study treatment unreasonably hazardous for the patient
- Acute bacterial or fungal infection requiring IV antibiotics
- Uncontrolled malabsorption syndrome significantly affecting gastrointestinal function
- Any unresolved bowel or bile duct obstruction
- Major resection of the stomach or small bowel that could affect the absorption of capecitabine
- AIDS based upon current CDC definition
- HIV testing is not required for study entry
- No prior allergic reaction to capecitabine or gemcitabine hydrochloride
PRIOR CONCURRENT THERAPY:
- No prior radiotherapy to the region of the study cancer that would result in overlap of radiotherapy fields
- No prior treatment with TRAIL-receptor agonists
- No prior systemic chemotherapy for pancreatic cancer
- More than 2 years since prior chemotherapy for malignancies other than pancreatic cancer
- More than 28 days since prior major surgery (e.g., biliary or gastric bypass)
- Insertion of a vascular access device, exploratory laparotomy, or laparoscopy are not considered major surgery
- No concurrent intensity-modulated radiotherapy
- No other concurrent chemotherapy
- No other concurrent monoclonal antibody therapy
- No concurrent sorivudine, brivudine A, or cimetidine
- No concurrent participation in another clinical trial
- Concurrent oral anticoagulants (e.g., warfarin) allowed provided INR is monitored
About this study
Official title: A Phase I/II Study of Induction Conatumumab and Gemcitabine, Followed by Conatumumab, Capecitabine and 3-D Conformal Radiation Therapy (3D-CRT) With Subsequent Maintenance Therapy for Locally Advanced Pancreatic Cancer
RATIONALE: Monoclonal antibodies, such as conatumumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Drugs used in chemotherapy, such as gemcitabine hydrochloride and capecitabine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Radiation therapy may uses high energy x-rays to kill tumor cells. Giving conatumumab together with gemcitabine hydrochloride, capecitabine, and radiation therapy may kill more tumor cells.
PURPOSE: This phase I/II trial is studying the side effects and best dose of conatumumab when given together with gemcitabine hydrochloride, capecitabine, and radiation therapy and to see how well they work in treating patients with locally advanced pancreatic cancer.
Read the detailed description
OBJECTIVES:
Primary
- To evaluate the maximum tolerated dose of conatumumab up to a target dose of 10 mg/kg given concurrently with capecitabine and radiotherapy following induction therapy comprising conatumumab and gemcitabine hydrochloride in patients with locally advanced pancreatic cancer. (Phase I)
- To evaluate the overall survival of patients treated with this regimen. (Phase II)
Secondary
- To evaluate the safety profile in patients treated with this regimen. (Phase I and II)
- To evaluate the progression-free survival of patients treated with this regimen. (Phase II)
- To evaluate the primary tumor response rate in patients treated with this regimen. (Phase II)
- To generate translational research hypotheses. (Phase II)
OUTLINE: This is a multicenter, phase I dose-escalation study of conatumumab, followed by a phase II study.
- Induction therapy: Patients receive conatumumab IV over 30-60 minutes on days 1 and 15 and gemcitabine hydrochloride IV over 30 minutes on days 1, 8, and 15. Treatment repeats every 28 days for 2 courses.
- Conatumumab and chemoradiotherapy: Beginning 14-42 days after the last course of induction therapy, patients undergo 3-dimensional radiotherapy once daily, 5 days a week, for 5½ weeks (28 treatments). Patients also receive conatumumab IV over 30-60 minutes on days 1, 15, and 29 and oral capecitabine twice daily, 5 days a week, for 5½ weeks.
- Maintenance therapy: Beginning 28-56 days after completion of chemoradiotherapy, patients receive conatumumab IV over 30-60 minutes on days 1 and 15 and gemcitabine hydrochloride IV over 30 minutes on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up periodically.
- Conditions
- Pancreatic Cancer
- Being tested
- conatumumab, capecitabine, gemcitabine hydrochloride, 3-dimensional conformal radiation therapy
- Keywords
- adenocarcinoma of the pancreas, stage III pancreatic cancer
- Medical subject headings
- Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
conatumumabBiological
capecitabineDrug
3-dimensional conformal radiation therapyRadiation
What is being measured
The primary outcome is the main question the study is designed to answer.
Dose-limiting toxicity (Phase I)
Overall survival (Phase II)
Secondary outcomes (3)
Adverse events (Phase I and II)
Progression-free survival (Phase II)
Response rate (Phase II)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Nov 2009 (estimated)
Why it stopped: This study was withdrawn due to study agent availability.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancreatic CancerStudies of the same condition, open and under way.
- 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 1/2
- Primary purpose
- Treatment
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Radiation Therapy Oncology Group
- Sponsor type
- Research network
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Christopher H. Crane, MD, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01017822
- Sponsor's protocol ID
- RTOG-0932
- Other IDs
- CDR0000659527
- Status last verified
- Jun 2013
- First submitted
- 20 Nov 2009
- Last updated
- 24 Jun 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I/II Study of Induction Conatumumab and Gemcitabine, Followed by Conatumumab, Capecitabine and 3-D Conformal Radiation Therapy (3D-CRT) With Subsequent Maintenance Therapy for Locally Advanced Pancreatic Cancer
- ClinicalTrials.gov ID
- NCT01017822
- Acronym / sponsor ID
- RTOG-0932
- Conditions
- Pancreatic Cancer
- Keywords
- adenocarcinoma of the pancreas, stage III pancreatic cancer
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: This study was withdrawn due to study agent availability.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Radiation Therapy Oncology GroupResearch network
- Collaborators
- National Cancer Institute (NCI)
- First posted
- 23 Nov 2009 (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: Monoclonal antibodies, such as conatumumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Drugs used in chemotherapy, such as gemcitabine hydrochloride and capecitabine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Radiation therapy may uses high energy x-rays to kill tumor cells. Giving conatumumab together with gemcitabine hydrochloride, capecitabine, and radiation therapy may kill more tumor cells.
PURPOSE: This phase I/II trial is studying the side effects and best dose of conatumumab when given together with gemcitabine hydrochloride, capecitabine, and radiation therapy and to see how well they work in treating patients with locally advanced pancreatic cancer.
Detailed description
OBJECTIVES:
Primary
- To evaluate the maximum tolerated dose of conatumumab up to a target dose of 10 mg/kg given concurrently with capecitabine and radiotherapy following induction therapy comprising conatumumab and gemcitabine hydrochloride in patients with locally advanced pancreatic cancer. (Phase I)
- To evaluate the overall survival of patients treated with this regimen. (Phase II)
Secondary
- To evaluate the safety profile in patients treated with this regimen. (Phase I and II)
- To evaluate the progression-free survival of patients treated with this regimen. (Phase II)
- To evaluate the primary tumor response rate in patients treated with this regimen. (Phase II)
- To generate translational research hypotheses. (Phase II)
OUTLINE: This is a multicenter, phase I dose-escalation study of conatumumab, followed by a phase II study.
- Induction therapy: Patients receive conatumumab IV over 30-60 minutes on days 1 and 15 and gemcitabine hydrochloride IV over 30 minutes on days 1, 8, and 15. Treatment repeats every 28 days for 2 courses.
- Conatumumab and chemoradiotherapy: Beginning 14-42 days after the last course of induction therapy, patients undergo 3-dimensional radiotherapy once daily, 5 days a week, for 5½ weeks (28 treatments). Patients also receive conatumumab IV over 30-60 minutes on days 1, 15, and 29 and oral capecitabine twice daily, 5 days a week, for 5½ weeks.
- Maintenance therapy: Beginning 28-56 days after completion of chemoradiotherapy, patients receive conatumumab IV over 30-60 minutes on days 1 and 15 and gemcitabine hydrochloride IV over 30 minutes on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up periodically.
Study design
- Primary purpose
- Treatment
- Masking
- None (open label)
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 |
|---|---|---|
| conatumumab | Biological | – |
| capecitabine | Drug | – |
| gemcitabine hydrochloride | Drug | – |
| 3-dimensional conformal radiation therapy | Radiation | – |
Primary outcome
Dose-limiting toxicity (Phase I)
Overall survival (Phase II)
3 secondary outcomes
Adverse events (Phase I and II)
Progression-free survival (Phase II)
Response rate (Phase II)
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2013.
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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.
Christopher H. Crane, MD principal investigator
M.D. Anderson Cancer Center
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing conatumumab, capecitabine and gemcitabine hydrochloride in people with Pancreatic Cancer, run by Radiation Therapy Oncology Group.
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: withdrawn, as of the sponsor's last update on 24 Jun 2013. Status can change between updates, so confirm with the study contact before making plans.
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 combined 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.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 was withdrawn before enrolling participants, so there are no results.
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?
Dose-limiting toxicity (Phase I). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
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 24 Jun 2013.