Pancreatic NeoplasmsPhase 1/2NCT00634751
CO07204-Phase I/II of Oxaliplatin, Capecitabine & Sorafenib for Advanced Pancreatic & Biliary Carcinoma
A Phase 1/2 study testing Oxaliplatin, Capecitabine and Sorafenib in people with Pancreatic Neoplasms and Bile Duct Neoplasms, run by University of Wisconsin, Madison at 1 site in United States.
Trial summary
This study involves the use of oxaliplatin, capecitabine, and sorafenib which are all drugs approved by the Food and Drug Administration (FDA) for use in the treatment of different cancers. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pancreatic Neoplasms, Bile Duct Neoplasms
- What is being tested?
- Oxaliplatin, Capecitabine and Sorafenib
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2008to Jul 2010
- Phase
- Phase 1/2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
Who may be able to join
- Patients must have histologically or cytologically confirmed locally advanced inoperable or metastatic adenocarcinoma of the pancreas or biliary tract who have not previously received more than one systemic treatment for their disease.
- Age at least 18 years old
- ECOG performance status 0-2.
- Patients must have adequate organ and marrow function as defined below:
- WBC at least 3,000
- ANC at least 1,500
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- PLT at least 100,000
- total bilirubin must be less than 2.5 x institutional upper limit of norm
- AST(SGOT)/ALT(SGPT) must be less than 5 X institutional upper limit of normal
- creatinine clearance must be greater than 50 mL/min as calculated by the Cockroft-Gault formula
- Patients with ≤ grade 2 (CTC 3.0) neuropathy.
- At least one measurable lesion as defined by RECIST criteria
- The effects of oxaliplatin, capecitabine and sorafenib on the developing human fetus at the recommended therapeutic dose are unknown. For this reason and because DNA alkylating agents are known to be teratogenic, women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately.
- Because the risk of toxicity in nursing infants secondary to oxaliplatin treatment of the mother is unknown but may be harmful, breastfeeding should be discontinued if the mother is treated with oxaliplatin.
- Ability to understand and the willingness to sign a written informed consent document.
Who cannot join
- No concomitant radiation therapy, or other systemic cancer therapies.
- Patients with known brain metastases should be excluded from this clinical trial because of their poor prognosis and because they often develop progressive neurologic dysfunction that would confound the evaluation of neurologic and other toxicities.
- History of allergy to platinum compounds, capecitabine, sorafenib or to antiemetics appropriate for administration in conjunction with protocol-directed chemotherapy.
- Uncontrolled intercurrent illness including, but not limited to: ongoing or active infection, thrombolic or embolic events such as cerebrovascular accident including transient ischemic attacks within the past 6 months, symptomatic congestive heart failure, unstable angina pectoris within 3 months prior to entry study, myocardial infarction within 6 months prior to study entry, ongoing cardiac arrhythmia (excluding atrial fibrillation), uncontrolled hypertension (systolic blood pressure > 150 mmHg or diastolic blood pressure > 90 mmHg, despite optimal medical management), pulmonary hemorrhage/bleeding event > CTCAE Grade 2 within 4 weeks of first dose of study drug, or any other hemorrhage/bleeding event > CTCAE Grade 3 within 4 weeks of first dose of study drug, serious non-healing wound, ulcer, or bone fracture, evidence or history of bleeding diathesis or coagulopathy.
- Pregnant or nursing women are excluded from this study because oxaliplatin, capecitabine and sorafenib is a DNA alkylating agent with the potential for teratogenic or abortifacient effects. Female patients of reproductive potential must have a negative urine or serum pregnancy test within two weeks prior to enrolling.
- Major surgery, open biopsy or significant traumatic injury within 4 weeks of first study drug.
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- Because of drug interactions with sorafenib, use of St. John's Wort or rifampin (rifampicin) is contraindicated. Patients may discontinue the use of these drugs to become eligible for the study
- Any condition that impairs patient's ability to swallow whole pills.
- HIV-positive patients receiving anti-retroviral therapy (HAART) are excluded from the study because of possible pharmacokinetic interactions.
- Second malignancy within the past 3 years (excluding nonmelanoma skin cancer and in situ cancers) that has not been treated with curative intent and is not currently without evidence of disease,
- Patients with known gastrointestinal malabsorption syndromes are excluded as this concurrent illness will affect absorption of the oral medications.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase I/II STudy of Oxaliplatin, Oral Capecitabine and Sorafenib in Patients With Advanced Pancreatic and Biliary Carcinoma"
This study involves the use of oxaliplatin, capecitabine, and sorafenib which are all drugs approved by the Food and Drug Administration (FDA) for use in the treatment of different cancers. Their use in this exact combination is considered experimental for the treatment of pancreas and biliary tract; however the combination has been tested in a preliminary trial. We are also testing a survey designed. The purpose of this research study is to investigate the chemotherapy drug sorafenib in combination with oxaliplatin and capecitabine chemotherapies for the treatment of pancreas and biliary tract cancers.to help patients report their side effects from chemotherapy treatments.
Read the detailed description
Primary Objectives
- To assess the overall safety of sorafenib when administered with "the 2DOC regimen" capecitabine and oxaliplatin in patients with advanced or metastatic pancreas or biliary tract cancers.
- To define the dose limiting toxicity and maximally tolerated dose of this combination.
- To assess the clinical response rate (stable, partial and complete responses) of the combination in patients with advanced or metastatic pancreas or biliary tract cancers.
Secondary Objectives
- To define the time to progression and overall survival for patients treated with this regimen.
- To evaluate the congruency of the Adverse Events Self-Report Survey in determining patient reported side effects of treatment
- Conditions
- Pancreatic Neoplasms, Bile Duct Neoplasms
- Being tested
- Oxaliplatin, Capecitabine, Sorafenib
- Keywords
- advanced pancreatic and biliary tract carcinomas
- Medical subject headings
- Pancreatic Neoplasms, Bile Duct Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OxaliplatinDrug
On days 1 and 15 of each 28 day treatment cycle, patients receive oxaliplatin 85 mg/m2 as a 2-hour IV infusion. Following the infusion of oxaliplatin, the infusion line should be flushed with Dextrose 5% in Water.
CapecitabineDrug
Each course of oral capecitabine administration will commence following administration of oxaliplatin. Capecitabine 2250 mg/m2 will be given every 8 hours for a total of 6 doses as above, commencing with each cycle of therapy. Because capecitabine is provided in fixed dose forms, rounding will be necessary. Rounding will be to the nearest 150 mg on a per dose basis.
SorafenibDrug
Cohort 1 will receive 200 mg of sorafenib orally twice daily, cohort 2 will receive 400 mg orally twice daily, both beginning on the first day of the first cycle (see section 9.1). If needed, cohort -1 will be used, at 200 mg of sorafenib once daily. Sorafenib should be taken without food (at least 1 hour before or 2 hours after eating).
Cohort I (Dose escalation phase) Agent Dose Route Day Cycle length
Sorafenib 200 mg BID Oral Daily Every 28 days
If 1/3 patients develop a DLT, enroll 3 patients at dose level -1 Sorafenib 200 mg po qd.
Cohort II (Phase II studies at MTD) Agent Dose Route Day Cycle length
Sorafenib 400 mg BID Oral Daily Every 28 days
| Study group | Role | What they receive |
|---|---|---|
| Phase I: 200mg Sorafenib+2DOC | Experimental | Cohort 1: 200mg Sorafenib+2DOC
Oxaliplatin + Oral Capecitabine + Sorafenib Receives: Drug: Oxaliplatin; Drug: Capecitabine; Drug: Sorafenib |
| Phase I: 400mg Sorafenib BID+2DOC | Experimental | Cohort 2: 400mg Sorafenib+2DOC
Oxaliplatin + Oral Capecitabine + Sorafenib Receives: Drug: Oxaliplatin; Drug: Capecitabine; Drug: Sorafenib |
| Phase II: Pancreatic Cancer | Experimental | Oxaliplatin + Oral Capecitabine + Sorafeni Receives: Drug: Oxaliplatin; Drug: Capecitabine; Drug: Sorafenib |
| Phase II: Biliary Tract Cancer | Experimental | Oxaliplatin + Oral Capecitabine + Sorafeni Receives: Drug: Oxaliplatin; Drug: Capecitabine; Drug: Sorafenib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Response Rate
Response rate of participant to treatment
Measured: Up to 18 months
Secondary outcomes (2)
Progression-free Survival (PFS)
Time to progression, defined as number of days from day of first study drug administration to the day the patient experiences an event of disease progression or death; summarized using point estimates of the median time to progression and associated 95% confidence intervals for each stratum separately.
Measured: Up to 18 months
Overall Survival
Overall survival, defined as number of days from the day of first study drug administration to the day the patient dies, summarized using point estimates of the median time to progression, and associated 95% confidence intervals
Measured: Up to 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2008 (estimated)
- Study startFeb 2008
- Primary completionJul 2010
- Study completionJul 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Pancreatic NeoplasmsStudies of the same condition, open and under way.
- More trials run by University of Wisconsin, MadisonThe 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 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Wisconsin, Madison
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Noelle K LoConte, M.D., Principal investigator, University of Wisconsin, Madison
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00634751
- Sponsor's protocol ID
- 2007-0248
- Other IDs
- CO07204, H-2007-0248, NCI-2011-00475, A534260, SMPH\MEDICINE\HEM-ONC
- Status last verified
- Jul 2017
- First submitted
- 5 Mar 2008
- Last updated
- 26 Nov 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 26 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I/II STudy of Oxaliplatin, Oral Capecitabine and Sorafenib in Patients With Advanced Pancreatic and Biliary Carcinoma"
- ClinicalTrials.gov ID
- NCT00634751
- Acronym / sponsor ID
- 2007-0248
- Conditions
- Pancreatic Neoplasms, Bile Duct Neoplasms
- Keywords
- advanced pancreatic and biliary tract carcinomas
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- University of Wisconsin, MadisonUniversity, hospital or other
- Collaborators
- Bayer, Sanofi
- Study start
- Feb 2008
- Primary completion
- Jul 2010 (actual)
- Study completion
- Jul 2010 (actual)
- First posted
- 13 Mar 2008 (estimated)
- Results
- Posted 8 Aug 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study involves the use of oxaliplatin, capecitabine, and sorafenib which are all drugs approved by the Food and Drug Administration (FDA) for use in the treatment of different cancers. Their use in this exact combination is considered experimental for the treatment of pancreas and biliary tract; however the combination has been tested in a preliminary trial. We are also testing a survey designed. The purpose of this research study is to investigate the chemotherapy drug sorafenib in combination with oxaliplatin and capecitabine chemotherapies for the treatment of pancreas and biliary tract cancers.to help patients report their side effects from chemotherapy treatments.
Detailed description
Primary Objectives
- To assess the overall safety of sorafenib when administered with "the 2DOC regimen" capecitabine and oxaliplatin in patients with advanced or metastatic pancreas or biliary tract cancers.
- To define the dose limiting toxicity and maximally tolerated dose of this combination.
- To assess the clinical response rate (stable, partial and complete responses) of the combination in patients with advanced or metastatic pancreas or biliary tract cancers.
Secondary Objectives
- To define the time to progression and overall survival for patients treated with this regimen.
- To evaluate the congruency of the Adverse Events Self-Report Survey in determining patient reported side effects of treatment
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Phase I: 200mg Sorafenib+2DOC | Experimental | Drug: Oxaliplatin, Drug: Capecitabine, Drug: SorafenibCohort 1: 200mg Sorafenib+2DOC Oxaliplatin + Oral Capecitabine + Sorafenib |
| Phase I: 400mg Sorafenib BID+2DOC | Experimental | Drug: Oxaliplatin, Drug: Capecitabine, Drug: SorafenibCohort 2: 400mg Sorafenib+2DOC Oxaliplatin + Oral Capecitabine + Sorafenib |
| Phase II: Pancreatic Cancer | Experimental | Drug: Oxaliplatin, Drug: Capecitabine, Drug: SorafenibOxaliplatin + Oral Capecitabine + Sorafeni |
| Phase II: Biliary Tract Cancer | Experimental | Drug: Oxaliplatin, Drug: Capecitabine, Drug: SorafenibOxaliplatin + Oral Capecitabine + Sorafeni |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- Patients must have histologically or cytologically confirmed locally advanced inoperable or metastatic adenocarcinoma of the pancreas or biliary tract who have not previously received more than one systemic treatment for their disease.
- Age at least 18 years old
- ECOG performance status 0-2.
- Patients must have adequate organ and marrow function as defined below:
- WBC at least 3,000
Key exclusion criteria (11 listed)
- No concomitant radiation therapy, or other systemic cancer therapies.
- Patients with known brain metastases should be excluded from this clinical trial because of their poor prognosis and because they often develop progressive neurologic dysfunction that would confound the evaluation of neurologic and other toxicities.
- History of allergy to platinum compounds, capecitabine, sorafenib or to antiemetics appropriate for administration in conjunction with protocol-directed chemotherapy.
- Uncontrolled intercurrent illness including, but not limited to: ongoing or active infection, thrombolic or embolic events such as cerebrovascular accident including transient ischemic attacks within the past 6 months, symptomatic congestive heart failure, unstable angina pectoris within 3 months prior to entry study, myocardial infarction within 6 months prior to study entry, ongoing cardiac arrhythmia (excluding atrial fibrillation), uncontrolled hypertension (systolic blood pressure > 150 mmHg or diastolic blood pressure > 90 mmHg, despite optimal medical management), pulmonary hemorrhage/bleeding event > CTCAE Grade 2 within 4 weeks of first dose of study drug, or any other hemorrhage/bleeding event > CTCAE Grade 3 within 4 weeks of first dose of study drug, serious non-healing wound, ulcer, or bone fracture, evidence or history of bleeding diathesis or coagulopathy.
- Pregnant or nursing women are excluded from this study because oxaliplatin, capecitabine and sorafenib is a DNA alkylating agent with the potential for teratogenic or abortifacient effects. Female patients of reproductive potential must have a negative urine or serum pregnancy test within two weeks prior to enrolling.
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 |
|---|---|---|
| OxaliplatinOn days 1 and 15 of each 28 day treatment cycle, patients receive oxaliplatin 85 mg/m2 as a 2-hour IV infusion. Following the infusion of oxaliplatin, the infusion line should be flushed with Dextrose 5% in Water. | Drug | Phase I: 200mg Sorafenib+2DOC, Phase I: 400mg Sorafenib BID+2DOC, Phase II: Biliary Tract Cancer, Phase II: Pancreatic Cancer |
| CapecitabineEach course of oral capecitabine administration will commence following administration of oxaliplatin. Capecitabine 2250 mg/m2 will be given every 8 hours for a total of 6 doses as above, commencing with each cycle of therapy. Because capecitabine is provided in fixed dose forms, rounding will be necessary. Rounding will be to the nearest 150 mg on a per dose basis. | Drug | Phase I: 200mg Sorafenib+2DOC, Phase I: 400mg Sorafenib BID+2DOC, Phase II: Biliary Tract Cancer, Phase II: Pancreatic Cancer |
| SorafenibCohort 1 will receive 200 mg of sorafenib orally twice daily, cohort 2 will receive 400 mg orally twice daily, both beginning on the first day of the first cycle (see section 9.1). If needed, cohort -1 will be used, at 200 mg of sorafenib once daily. Sorafenib should be taken without food (at least 1 hour before or 2 hours after eating). Cohort I (Dose escalation phase) Agent Dose Route Day Cycle length Sorafenib 200 mg BID Oral Daily Every 28 days If 1/3 patients develop a DLT, enroll 3 patients at dose level -1 Sorafenib 200 mg po qd. Cohort II (Phase II studies at MTD) Agent Dose Route Day Cycle length Sorafenib 400 mg BID Oral Daily Every 28 days | Drug | Phase I: 200mg Sorafenib+2DOC, Phase I: 400mg Sorafenib BID+2DOC, Phase II: Biliary Tract Cancer, Phase II: Pancreatic Cancer |
Primary outcome
Overall Response Rate
Time frame: Up to 18 months
Response rate of participant to treatment
2 secondary outcomes
Progression-free Survival (PFS)
Time frame: Up to 18 months
Overall Survival
Time frame: Up to 18 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Nov 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- University of Wisconsin Carbone Cancer CenterLink provided by the sponsor.
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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.
Noelle K LoConte, M.D. principal investigator
University of Wisconsin, Madison
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Oxaliplatin, Capecitabine and Sorafenib in people with Pancreatic Neoplasms and Bile Duct Neoplasms, run by University of Wisconsin, Madison at 1 site 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?
The sponsor lists 15 inclusion and 11 exclusion criteria. 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 26 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 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?
Yes. Results are posted in the registry (first posted 8 Aug 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Overall Response Rate (time frame: Up to 18 months). 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 26 Nov 2019.