Pancreatic CancerPhase 2NCT00386399
Study of Mitomycin-C in Patients With Advanced or Recurrent Pancreatic Cancer With Mutated BRCA2 Gene
A Phase 2 study testing Mitomycin-C in people with Pancreatic Cancer, run by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins at 1 site in United States.
Trial summary
Patients will be tested for mutations in the BRCA2 gene. If they have a BRCA2 mutation, they will be treated with Mitomycin-C as described here. The patients with an identified gene mutation will also be provided with genetic counseling. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Pancreatic Cancer
- What is being tested?
- Mitomycin-C
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2006to Feb 2008
- 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 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histological or cytological proven adenocarcinoma of the pancreas.
- Locally advanced unresectable or metastatic disease not amenable to curative treatment.
- No prior treatment for advanced disease. Patient may have received adjuvant treatment after curative resection. Patients who have received gemcitabine as part of their adjuvant treatment need to have at least a 6 month progression free interval after gemcitabine has been discontinued.
- BRCA2 deleterious mutation, or genetic variant, suspected deleterious, by DNA testing.
- No prior treatment with MMC.
- Age ≥18 years old.
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- ECOG PS 0-1.
- Expected > 12 weeks survival.
- Adequate renal, liver and bone-marrow function as determined by:
- Ability to understand and willingness to sign a written informed consent.
- Willingness of male and female subjects, who are not surgically sterile or post-menopausal, to use reliable methods of birth control (oral contraceptives, intrauterine devices, or barrier methods) for the duration of the study and for 30 days after the last dose of study medication.
Who cannot join
- Patients in whom histologic or cytologic diagnosis is not consistent with adenocarcinoma including adenosquamous, islet cell, cystadenoma or cystadenocarcinoma, carcinoid, small or large cell carcinoma or lymphoma.
- Adenocarcinoma arising from a site other than pancreas (distal common bile duct, ampulla of vater or periampullary duodenum).
- 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 adverse events.
- Patients who have had any previous surgery, excluding minor procedures, dental work, skin biopsy, etc. within 4 weeks of enrollment.
- Uncontrolled medical conditions that could potentially increase the risk of toxicities or complications of this therapy including immunodeficiency and chronic treatment with immunosuppressors. Gastrointestinal tract disease resulting in an inability to take oral medication or a requirement for IV alimentation, prior surgical procedures affecting absorption, or active peptic ulcer disease.
- Active infections.
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- History of concurrent malignancy or history of a second malignancy within the past 5 years, except squamous cell and basal cell carcinoma of the skin.
- Participation in an investigational new drug trial within one month of starting trial.
- Unable to provide informed consent.
- Concomitant use of phenytoin, carbamazepine, barbiturates, rifampin, phenobarbital or St. Johns Wort.
- Treatment with chemotherapy within 30 days of day 1 treatment.
- Any unresolved chronic toxicity greater than CTCAE grade 2 from previous anticancer therapy (except alopecia).
- Pregnant women are excluded from this study because the effects of MMC on the developing fetus are not known (FDA Pregnancy Category C). Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with MMC, breast feeding should be discontinued if the mother is treated with the drug.
- Patients must not have clinically significant cardiovascular disease including myocardial infarction (within 12 months prior to randomization), unstable angina, grade II or greater peripheral vascular disease, uncontrolled congestive heart failure or uncontrolled hypertension (SBP>170, DBP>95).
Trial locations and contacts
1 site in 1 country.
United States1 site
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore, Maryland, 21205
About this study
Official title: Phase II Study of Mitomycin-C in Patients With Advanced or Recurrent Pancreatic Cancer With Mutated BRCA2 Gene
Patients will be tested for mutations in the BRCA2 gene. If they have a BRCA2 mutation, they will be treated with Mitomycin-C as described here. The patients with an identified gene mutation will also be provided with genetic counseling.
Read the detailed description
Patients will be tested for mutations in the BRCA2 gene. If they have a BRCA2 mutation, they will be treated with Mitomycin-C as described here. The patients with an identified gene mutation will also be provided with genetic counseling.
Patients with BRCA2 gene will be treated with Mitomycin-C (MMC) on Day 1 at a dose of 10mg/m2 intravenously. This will be repeated every 28 days, which is one cycle. Expected adverse events and appropriate dose modifications are described in this section. Treatment will continue until disease progression, serious toxicity, patient withdrawal or maximum cumulative dose of 60 mg/m2.
Primary Objectives:
- To determine the 6-month survival of patients with previously untreated advanced or recurrent adenocarcinoma of the pancreas with BRCA2 mutations that are treated with single agent Mitomycin-C (MMC) chemotherapy.
Secondary Objectives:
- To determine the response rate, six-month progression free survival rate, progression-free survival and survival of patients with previously untreated advanced or recurrent adenocarcinoma of the pancreas with BRCA2 mutations who are treated with single agent MMC chemotherapy.
- To describe the toxicity of MMC in this patient population.
- To explore pharmacogenetic factors that may influence the toxicity and efficacy of MMC in this patient population.
- Conditions
- Pancreatic Cancer
- Being tested
- Mitomycin-C
- Keywords
- Advanced Pancreatic Cancer, Mutated BRCA2 Gene, Recurrent 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.
Mitomycin-CDrug
Also called Mytomycin C
Mitomycin C, finds use as a chemotherapeutic agent by virtue of its antitumour antibiotic activity.
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Experimental | Patients with BRCA2 gene will be treated with Mitomycin-C (MMC) on Day 1 at a dose of 10mg/m2 intravenously. This will be repeated every 28 days, which is one cycle. Treatment will continue until disease progression, serious toxicity, patient withdrawal or maximum cumulative dose of 60 mg/m2 Receives: Drug: Mitomycin-C |
What is being measured
The primary outcome is the main question the study is designed to answer.
6-month overall survival
Number of participants with previously untreated advanced or recurrent adenocarcinoma of the pancreas with BRCA2 mutations that are alive after 6-months after being treated with single agent Mitomycin-C (MMC) chemotherapy.
Measured: up to 6 months
Secondary outcomes (6)
Response rate
Proportion of participants with reduction in tumor burden of previously untreated advanced or recurrent adenocarcinoma of the pancreas with BRCA2 mutations who are treated with single agent MMC chemotherapy.
Measured: up to 2.5 years
Progression-free survival at 6 months
Number of participants who are treated with single agent MMC chemotherapy and have partial or complete response of previously untreated advanced or recurrent adenocarcinoma of the pancreas with BRCA2 mutations.
Measured: up to 6 months
Progression-free survival
Number of participants who are treated with single agent MMC chemotherapy and have partial or complete response of previously untreated advanced or recurrent adenocarcinoma of the pancreas with BRCA2 mutations.
Measured: up to 2.5 years
Overall survival
Number of participants with previously untreated advanced or recurrent adenocarcinoma of the pancreas with BRCA2 mutations who are alive after being treated with single agent MMC chemotherapy.
Measured: up to 2.5 years
Toxicity as assessed by number of participants experiencing adverse events.
Measured: Up to 2.5 years
To explore pharmacogenetic factors that may influence the toxicity and efficacy of MMC in this patient population.
Measured: 2.5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Oct 2006 (estimated)
- Study startOct 2006
- Primary completionFeb 2008
- Study completionFeb 2008
Why it stopped: All consented subjects tested negative for the BRCA2 mutation, therefore, did not meet criteria to start the study, resulting in withdrawal by PI
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.
- More trials run by Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsThe 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 2
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Van Andel Research Institute
- Responsible party
- Sponsor
- Investigators
- Manuel Hidalgo, MD, PhD, Study chair, Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00386399
- Sponsor's protocol ID
- J0626
- Other IDs
- NA_00002002
- Status last verified
- Jul 2018
- First submitted
- 10 Oct 2006
- Last updated
- 12 Jul 2018
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Study of Mitomycin-C in Patients With Advanced or Recurrent Pancreatic Cancer With Mutated BRCA2 Gene
- ClinicalTrials.gov ID
- NCT00386399
- Acronym / sponsor ID
- J0626
- Conditions
- Pancreatic Cancer
- Keywords
- Advanced Pancreatic Cancer, Mutated BRCA2 Gene, Recurrent Pancreatic Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: All consented subjects tested negative for the BRCA2 mutation, therefore, did not meet criteria to start the study, resulting in withdrawal by PI
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsUniversity, hospital or other
- Collaborators
- Van Andel Research Institute
- Study start
- Oct 2006
- Primary completion
- Feb 2008 (actual)
- Study completion
- Feb 2008 (actual)
- First posted
- 11 Oct 2006 (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.
Patients will be tested for mutations in the BRCA2 gene. If they have a BRCA2 mutation, they will be treated with Mitomycin-C as described here. The patients with an identified gene mutation will also be provided with genetic counseling.
Detailed description
Patients will be tested for mutations in the BRCA2 gene. If they have a BRCA2 mutation, they will be treated with Mitomycin-C as described here. The patients with an identified gene mutation will also be provided with genetic counseling.
Patients with BRCA2 gene will be treated with Mitomycin-C (MMC) on Day 1 at a dose of 10mg/m2 intravenously. This will be repeated every 28 days, which is one cycle. Expected adverse events and appropriate dose modifications are described in this section. Treatment will continue until disease progression, serious toxicity, patient withdrawal or maximum cumulative dose of 60 mg/m2.
Primary Objectives:
- To determine the 6-month survival of patients with previously untreated advanced or recurrent adenocarcinoma of the pancreas with BRCA2 mutations that are treated with single agent Mitomycin-C (MMC) chemotherapy.
Secondary Objectives:
- To determine the response rate, six-month progression free survival rate, progression-free survival and survival of patients with previously untreated advanced or recurrent adenocarcinoma of the pancreas with BRCA2 mutations who are treated with single agent MMC chemotherapy.
- To describe the toxicity of MMC in this patient population.
- To explore pharmacogenetic factors that may influence the toxicity and efficacy of MMC in this patient population.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | Experimental | Drug: Mitomycin-CPatients with BRCA2 gene will be treated with Mitomycin-C (MMC) on Day 1 at a dose of 10mg/m2 intravenously. This will be repeated every 28 days, which is one cycle. Treatment will continue until disease progression, serious toxicity, patient withdrawal or maximum cumulative dose of 60 mg/m2 |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Histological or cytological proven adenocarcinoma of the pancreas.
- Locally advanced unresectable or metastatic disease not amenable to curative treatment.
- No prior treatment for advanced disease. Patient may have received adjuvant treatment after curative resection. Patients who have received gemcitabine as part of their adjuvant treatment need to have at least a 6 month progression free interval after gemcitabine has been discontinued.
- BRCA2 deleterious mutation, or genetic variant, suspected deleterious, by DNA testing.
- No prior treatment with MMC.
Key exclusion criteria (14 listed)
- Patients in whom histologic or cytologic diagnosis is not consistent with adenocarcinoma including adenosquamous, islet cell, cystadenoma or cystadenocarcinoma, carcinoid, small or large cell carcinoma or lymphoma.
- Adenocarcinoma arising from a site other than pancreas (distal common bile duct, ampulla of vater or periampullary duodenum).
- 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 adverse events.
- Patients who have had any previous surgery, excluding minor procedures, dental work, skin biopsy, etc. within 4 weeks of enrollment.
- Uncontrolled medical conditions that could potentially increase the risk of toxicities or complications of this therapy including immunodeficiency and chronic treatment with immunosuppressors. Gastrointestinal tract disease resulting in an inability to take oral medication or a requirement for IV alimentation, prior surgical procedures affecting absorption, or active peptic ulcer disease.
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 |
|---|---|---|
| Mitomycin-CAlso: Mytomycin CMitomycin C, finds use as a chemotherapeutic agent by virtue of its antitumour antibiotic activity. | Drug | Arm 1 |
Primary outcome
6-month overall survival
Time frame: up to 6 months
Number of participants with previously untreated advanced or recurrent adenocarcinoma of the pancreas with BRCA2 mutations that are alive after 6-months after being treated with single agent Mitomycin-C (MMC) chemotherapy.
6 secondary outcomes
Response rate
Time frame: up to 2.5 years
Progression-free survival at 6 months
Time frame: up to 6 months
Progression-free survival
Time frame: up to 2.5 years
Overall survival
Time frame: up to 2.5 years
Toxicity as assessed by number of participants experiencing adverse events.
Time frame: Up to 2.5 years
To explore pharmacogenetic factors that may influence the toxicity and efficacy of MMC in this patient population.
Time frame: 2.5 years
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 12 Jul 2018.
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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.
Manuel Hidalgo, MD, PhD study chair
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
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 Mitomycin-C in people with Pancreatic Cancer, run by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins 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 11 inclusion and 14 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: withdrawn, as of the sponsor's last update on 12 Jul 2018. 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 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 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?
6-month overall survival (time frame: up to 6 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 12 Jul 2018.