Pancreatic Adenocarcinoma Advanced or MetastaticPhase 2NCT01971034
Treatment of Patients With Advanced Pancreatic Cancer After Gemcitabine Failure.
A Phase 2 study testing Paclitaxel and Metformin in people with Pancreatic Adenocarcinoma Advanced or Metastatic, run by Instituto do Cancer do Estado de São Paulo at 1 site in Brazil.
Trial summary
In Brazil pancreatic adenocarcinoma represents 2% of tumors, and 4% mortality being an uncommon disease, however very aggressive.Only 20% of cases are indicated for curative surgery, of which only 20% are alive within 5 years. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pancreatic Adenocarcinoma Advanced or Metastatic
- What is being tested?
- Paclitaxel and Metformin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 41 participants
- Where
- 1 siteBrazil
- Study dates
- Jun 2011to Jun 2012
- Phase
- Phase 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
Who may be able to join
- Pancreatic advanced or metastatic adenocarcinoma histologically confirmed.
- Previously treatment with gemcitabine as adjuvant or metastatic disease.
- Clinical or radiological evidence of disease progression, determined by physician. Is not mandatory RECIST (Response Evaluation Criteria in Solid Tumors) evaluation to determine the progression of disease before the study inclusion.
- Patient with intolerance to gemcitabine, even without disease progression, are also eligible.
- Eastern Cooperative Oncology Group (ECOG) performance status 0 - 2
- At least 10 weeks of life expectation.
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- Adequate organ function defined as:
- Serum AST (aspartate aminotransferase) and ALT (alanine aminotransferase)≤ 2.5 × ULN (upper normal limit)
- Total Bilirubin ≤ 2,0 x ULN
- Absolute neutrophil count ≥ 1,500/ mm3
- Platelets ≥100.000/ mm3
- Hemoglobin ≥ 8,0 g/dl
- Serum Creatinine ≤ 1,5 ULN and clearance of creatinine estimated (Cockcroft- Gault) ≥ 50 ml/min
- Signed written informed consent.
Who cannot join
- Major surgical procedure within 4 weeks of the beginning of the treatment.
- History of serious clinical or psychiatric disease.
- Symptomatic hypoglycemia at the screening visit.
- Target lesion radiotherapy within 4 weeks of the beginning of the treatment.
- Treatment with any anti-cancer investigational drug.
- Treatment with any IGF-I or IGFR-I
- Treatment with metformin within 12 months prior to commencing study treatment
- For female patients, current pregnancy and/or lactation
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Prospective Study to Evaluate the Combination of Metformin With Paclitaxel in the Treatment of Patients With Advanced Pancreatic Cancer After Gemcitabine Failure.
In Brazil pancreatic adenocarcinoma represents 2% of tumors, and 4% mortality being an uncommon disease, however very aggressive.Only 20% of cases are indicated for curative surgery, of which only 20% are alive within 5 years. For locally, advanced or metastatic disease, since 1997, single chemotherapy with gemcitabine is the standard treatment for first line, with survival around 6 months approximately.There is no standard treatment regimen for second-line, however Paclitaxel demonstrated effect on second-line phase II study. Metformin is an oral hypoglycemic drug used for treatment of diabetes mellitus. There is a growing number of preclinical studies which show antitumor effect against pancreatic adenocarcinoma, probably due to the effect of anti-insulin growth factor (IGF-1). This study will add metformin to standard treatment for second line of locally advanced or metastatic pancreatic adenocarcinoma in ICESP previously treated with gemcitabine. The objective is to evaluate whether metformin improves the efficacy of the standard treatment with paclitaxel by clinical and radiological evaluation.
- Being tested
- Paclitaxel, Metformin
- Medical subject headings
- Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PaclitaxelDrug
80 mg/m2, IV, Day 1, Day 8 and Day 15.
MetforminDrug
850mg, PO, every 8 hours, daily.
| Study group | Role | What they receive |
|---|---|---|
| Paclitaxel and Metformin | Experimental | Not described Receives: Drug: Paclitaxel; Drug: Metformin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Radiologic control of disease
The radiologic image will be analyzed by RECIST 1.0 criteria.
Measured: Every 8 weeks from the date of first dose of treatment until disease progression.
Secondary outcomes (3)
Time to progression.
Thorax and abdominal computerized tomography and Ca 19.9 tumor marker dosage every 8 weeks until disease progression.
Measured: Every 8 weeks from the date of first dose of treatment until disease progression.
To estimate the biochemical response through the measurement of serum CA19.9 levels.
Measured: From the date of first dose of treatment until disease progression.
To evaluate the clinical benefits
Will be evaluate:
- ECOG
- Treatment with opioids
- Pain
- Weight
Measured: Every 4 weeks during the treatment period until disease progression.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2013 (estimated)
- Study startJun 2011
- Primary completionJun 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancreatic Adenocarcinoma Advanced or MetastaticStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 41 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Instituto do Cancer do Estado de São Paulo
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Rachel SP Riechelmann, MD, Principal investigator, Instituto do Cancer do Estado de São Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01971034
- Sponsor's protocol ID
- NP 96/2010
- Status last verified
- May 2014
- First submitted
- 6 Sep 2013
- Last updated
- 16 May 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Study to Evaluate the Combination of Metformin With Paclitaxel in the Treatment of Patients With Advanced Pancreatic Cancer After Gemcitabine Failure.
- ClinicalTrials.gov ID
- NCT01971034
- Acronym / sponsor ID
- NP 96/2010
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 41 participants (estimated)
- Lead sponsor
- Instituto do Cancer do Estado de São PauloUniversity, hospital or other
- Study start
- Jun 2011
- Primary completion
- Jun 2012 (actual)
- First posted
- 28 Oct 2013 (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.
In Brazil pancreatic adenocarcinoma represents 2% of tumors, and 4% mortality being an uncommon disease, however very aggressive.Only 20% of cases are indicated for curative surgery, of which only 20% are alive within 5 years. For locally, advanced or metastatic disease, since 1997, single chemotherapy with gemcitabine is the standard treatment for first line, with survival around 6 months approximately.There is no standard treatment regimen for second-line, however Paclitaxel demonstrated effect on second-line phase II study. Metformin is an oral hypoglycemic drug used for treatment of diabetes mellitus. There is a growing number of preclinical studies which show antitumor effect against pancreatic adenocarcinoma, probably due to the effect of anti-insulin growth factor (IGF-1). This study will add metformin to standard treatment for second line of locally advanced or metastatic pancreatic adenocarcinoma in ICESP previously treated with gemcitabine. The objective is to evaluate whether metformin improves the efficacy of the standard treatment with paclitaxel by clinical and radiological evaluation.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Paclitaxel and Metformin | Experimental | Drug: Paclitaxel, Drug: Metformin |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Pancreatic advanced or metastatic adenocarcinoma histologically confirmed.
- Previously treatment with gemcitabine as adjuvant or metastatic disease.
- Clinical or radiological evidence of disease progression, determined by physician. Is not mandatory RECIST (Response Evaluation Criteria in Solid Tumors) evaluation to determine the progression of disease before the study inclusion.
- Patient with intolerance to gemcitabine, even without disease progression, are also eligible.
- Eastern Cooperative Oncology Group (ECOG) performance status 0 - 2
Key exclusion criteria (8 listed)
- Major surgical procedure within 4 weeks of the beginning of the treatment.
- History of serious clinical or psychiatric disease.
- Symptomatic hypoglycemia at the screening visit.
- Target lesion radiotherapy within 4 weeks of the beginning of the treatment.
- Treatment with any anti-cancer investigational drug.
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 |
|---|---|---|
| Paclitaxel80 mg/m2, IV, Day 1, Day 8 and Day 15. | Drug | Paclitaxel and Metformin |
| Metformin850mg, PO, every 8 hours, daily. | Drug | Paclitaxel and Metformin |
Primary outcome
Radiologic control of disease
Time frame: Every 8 weeks from the date of first dose of treatment until disease progression.
The radiologic image will be analyzed by RECIST 1.0 criteria.
3 secondary outcomes
Time to progression.
Time frame: Every 8 weeks from the date of first dose of treatment until disease progression.
To estimate the biochemical response through the measurement of serum CA19.9 levels.
Time frame: From the date of first dose of treatment until disease progression.
To evaluate the clinical benefits
Time frame: Every 4 weeks during the treatment period until disease progression.
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 16 May 2014.
- Related InfoLink 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.
Rachel SP Riechelmann, MD principal investigator
Instituto do Cancer do Estado de São Paulo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Paclitaxel and Metformin in people with Pancreatic Adenocarcinoma Advanced or Metastatic, run by Instituto do Cancer do Estado de São Paulo at 1 site in Brazil.
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 14 inclusion and 8 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 16 May 2014. 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 Brazil. 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 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 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?
Radiologic control of disease (time frame: Every 8 weeks from the date of first dose of treatment until disease progression.). 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 16 May 2014.