Ovarian CancerPhase 1/2NCT01083537
Trial of Best Supportive Care and Either Cisplatin or Paclitaxel to Treat Patients With Primary Ovarian Cancer, Primary Peritoneal Cancer or Fallopian Tube Cancer and Inoperable Malignant Bowel Obstruction
A Phase 1/2 study testing Cisplatin and Paclitaxel in people with Ovarian Cancer and Peritoneal Cancer, run by University Health Network, Toronto at 1 site in Canada.
Trial summary
The best way to treat MBO in patients with ovarian cancer has not been studied enough by trials that assess how more than one treatment arm (surgical, chemotherapeutic, supportive care approaches) affects clinical outcomes like resolution of bowel obstruction, survival, and quality of life. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ovarian Cancer, Peritoneal Cancer, Fallopian Tube Cancer
- What is being tested?
- Cisplatin and Paclitaxel
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- 1 siteCanada
- Study dates
- Feb 2010to Jun 2012
- 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
Who may be able to join
- Hospital admission and diagnosis compatible with Malignant Bowel Obstruction, as defined below:
- A diagnosis of primary ovarian cancer, primary peritoneal cancer or fallopian tube cancer
- At least two of the following four symptoms: (a) vomiting (>2 episodes in past 24 hours), (b) abdominal pain, (c) not passing gas per rectum in past 24 hours, (d) severe constipation (no bowel movement >24 hours).
- CT findings suggestive of complete bowel obstruction. CT Abdomen: confirms diagnosis of bowel obstruction (93% sensitivity 93-100% specificity) and aids in determining the location and etiology of obstruction.
- Non-surgical candidate
- Ability to understand and the willingness to sign a written informed consent document.
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- Patients must be 18 years of age or older.
- ECOG performance status 0, 1 or 2 (Karnofsky > or = 60%) one week prior to admission.
- Patients must have adequate hematological function as defined below:
- Absolute granulocyte count > or = 1.5 x 10^9/L
- Platelet count > or = 100 x 10^9/L
- Patients must have adequate renal and hepatic function as defined below:
- Serum creatinine < or = 1.5 x ULN OR a calculated creatinine clearance > or = 50 ml/min
- Bilirubin < or = 3 x ULN, AST < or = 5 x ULN, ALT < or = 5 x ULN
Who cannot join
- Patients diagnosed with MBO caused by malignancy other than primary ovarian cancer.
- Patients diagnosed with MBO who are surgical candidates.
- Patients who are pregnant or breast-feeding.
- Concomitant diagnosis of GI malignancy (platinum ineffective) within past 5 years.
- History of severe hypersensitivity reaction to Cisplatin and Paclitaxel.
- Patients who have received chemotherapy within 2 weeks prior to study enrollment.
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- Patients with uncontrolled Inflammatory Bowel Disease.
- Patients with concurrent active infections with Clostridium Difficile.
- Early postoperative obstruction (within 30 days from previous operation).
- Patients who have had bowel irradiation within 6 weeks.
- Patients with any of the following conditions are excluded:
- Myocardial infarction within 6 months prior to entry.
- Congestive heart failure.
- Unstable angina.
- Active cardiomyopathy.
- Unstable ventricular arrhythmia.
- Uncontrolled hypertension.
- Uncontrolled psychotic disorders.
- Serious infections.
- Active peptic ulcer disease.
- Uncontrolled psychiatric illness.
- Any other medical conditions that might be aggravated by treatment or limit compliance.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase I/II Trial of Best Supportive Care and Chemotherapy, Either Cisplatin or Paclitaxel, in Patients With Primary Ovarian Cancer, Primary Peritoneal Cancer or Fallopian Tube Cancer Presenting With Inoperable Malignant Bowel Obstruction
The best way to treat MBO in patients with ovarian cancer has not been studied enough by trials that assess how more than one treatment arm (surgical, chemotherapeutic, supportive care approaches) affects clinical outcomes like resolution of bowel obstruction, survival, and quality of life. To improve patient outcomes, we must assess which patients will do better with palliative surgery, chemotherapy, or best supportive care. This study will gather safety information, and how reasonable it is to give chemotherapy and BSC to patients with advanced ovarian cancer and MBO who are non-surgical candidates. This study will also look into the effects of chemotherapy and BSC on the quality of life and resolution of bowel obstruction, in hopes to perform future studies that lead to the best management of MBO.
Read the detailed description
The optimal management of MBO in patients with ovarian cancer has not been defined by proper prospective randomized control trials evaluating the impact of defined multidisciplinary treatment arms (surgical, chemotherapeutic, supportive care approaches) on important clinical outcomes including resolution of bowel obstruction, survival endpoints and validated quality of life outcomes. In order to improve patient outcomes, we must define which patients will benefit from palliative surgery, which patients are appropriate candidates for chemotherapy and which patients will benefit most from best supportive care. This study will determine the safety, feasibility of chemotherapy and BSC in patients with advanced ovarian cancer presenting with MBO who are initially deemed non-surgical candidates and will identify the impact of chemotherapy and BSC on quality of life and resolution of bowel obstruction, in preparation for future prospective randomized studies to determine the optimal management of MBO.
- Being tested
- Cisplatin, Paclitaxel
- Keywords
- malignant bowel obstruction, ovarian cancer, Peritoneal cancer, Fallopian Tube cancer
- Medical subject headings
- Ovarian Neoplasms, Fallopian Tube Neoplasms, Intestinal Obstruction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CisplatinDrug
- Cisplatin administered at 60mg/m2 IV on Day 1, every 21 days for 2 cycles.
- Hesketh Level 5: 5HT3 receptor antagonist IV/po 30-60 mins pre-chemo and Dexamethasone 10-20mg po/IV 30-60 mins pre-chemo; Dexamethasone 4-8mg po BID x 3 days starting 24hours post last dose of chemo; Prochlorperazine 10mg po/IV q4-6h prn, metoclopramide 10-20mg po/iv q6h prn, haloperidol 0.5-2mg po/SC q 8-12 h prn
- Hydration: Pre-hydration 500-1000cc NS with 10Meq KCl over 2 hours; Infuse Cisplatin in 250-500cc NS over 1 hour; Post-hydration 1000cc NS + 20Meq KCl (+/- 2g MgSO4) over 1 hour
PaclitaxelDrug
- Paclitaxel administered 80mg/m2 IV on Days 1, 8 and 15, every 21 days for 2 cycles.
- Suggested prophylaxis for paclitaxel-associated hypersensitivity reactions: Dexamethasone 10-20mg po/IV 30-60 mins pre-chemo; diphenydramine 25-50mg IV 30-60 minutes pre-chemo, ranitidine 50mg IV 30-60 minutes pre-chemo
- Hesketh Level 2: Prochlorperazine 10mg po/IV q4-6h prn
- Hydration: Infuse Paclitaxel in 250cc NS over 1 hour
| Study group | Role | What they receive |
|---|---|---|
| Cisplatin | Experimental | Cisplatin administered at 60mg/m2 IV on Day 1, every 21 days for 2 cycles.
1. Hesketh Level 5: 5HT3 receptor antagonist IV/po 30-60 mins pre-chemo and Dexamethasone 10-20mg po/IV 30-60 mins pre-chemo; Dexamethasone 4-8mg po BID x 3 days starting 24hours post last dose of chemo; Prochlorperazine 10mg po/IV q4-6h prn, metoclopramide 10-20mg po/iv q6h prn, haloperidol 0.5-2mg po/SC q 8-12 h prn
2. Hydration: Pre-hydration 500-1000cc NS with 10Meq KCl over 2 hours; Infuse Cisplatin in 250-500cc NS over 1 hour; Post-hydration 1000cc NS + 20Meq KCl (+/- 2g MgSO4) over 1 hour Receives: Drug: Cisplatin |
| Paclitaxel | Experimental | Paclitaxel administered 80mg/m2 IV on Days 1, 8 and 15, every 21 days for 2 cycles.
1. Suggested prophylaxis for paclitaxel-associated hypersensitivity reactions: Dexamethasone 10-20mg po/IV 30-60 mins pre-chemo; diphenydramine 25-50mg IV 30-60 minutes pre-chemo, ranitidine 50mg IV 30-60 minutes pre-chemo
2. Hesketh Level 2: Prochlorperazine 10mg po/IV q4-6h prn
3. Hydration: Infuse Paclitaxel in 250cc NS over 1 hour Receives: Drug: Paclitaxel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Safety Profile
Type, frequency, severity (NCI CTCAE v.3.0.1) and relationship to trial treatment of adverse events and laboratory abnormalities. Frequency and severity of adverse events will be tabulated using counts and proportions detailing frequently occurring, serious and severe events of interest.
Measured: Day 1 of treatment until resolution of symptoms
Quality of Life Scores at Baseline, Day 30 and Day 90
Quality of life scores will be tabulated using counts and summary statistics. We hypothesize that at 30 days from treatment, there may be no improvement in quality of life scores compared to baseline. We hypothesize that at 90 days from treatment, there will be an improvement in quality of life scores from baseline by one third standard deviation. Paired T test and Mixed model will be used to make the comparison over different time period.
Measured: Day 1 of treatment until resolution of symptoms
Time to Resolution of Bowel Obstruction
Time to resolution of bowel obstruction and time to recurrence of bowel obstruction will be assessed using summary statistics including mean, median, counts and proportion, to summarize the patients.
Measured: Day 1 of treatment until resolution of symptoms
Secondary outcomes (2)
Survival
Survival: 30-day(all cause and disease-specific), 60-day(all cause and disease-specific), and 90-day mortality (all cause and disease-specific).
Summary statistics will be used to summarize the patients. Survival estimates will be computed using Kaplan-Meier method. Variable association will be measured using Pearson correlation coefficients, chi-square tests, one- or two-sample t-tests or logistic regression analyses. Non-parametric tests may be substituted if necessary. Results will be illustrated using figures and plots using 95 percent confidence intervals.
Measured: 30 days, 60 days, and 90 days from treatment start date
Evaluation of Toxicity
All patients will be evaluable for toxicity from the time they sign consent.
Measured: Time of consent until resolution of symptoms
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2010 (estimated)
- Study startFeb 2010
- Primary completionJun 2012
- Study completionJun 2012
Why it stopped: Slow accrual
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ovarian CancerStudies of the same condition, open and under way.
- More trials run by University Health Network, TorontoThe 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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Health Network, Toronto
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Amit Oza, Principal investigator, Princess Margaret Hospital, CanadaNicole Chau, Principal investigator, Princess Margaret Hospital, Canada
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01083537
- Sponsor's protocol ID
- MBO-CHEMO-BSC
- Status last verified
- Feb 2019
- First submitted
- 1 Mar 2010
- Last updated
- 15 Feb 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I/II Trial of Best Supportive Care and Chemotherapy, Either Cisplatin or Paclitaxel, in Patients With Primary Ovarian Cancer, Primary Peritoneal Cancer or Fallopian Tube Cancer Presenting With Inoperable Malignant Bowel Obstruction
- ClinicalTrials.gov ID
- NCT01083537
- Acronym / sponsor ID
- MBO-CHEMO-BSC
- Keywords
- malignant bowel obstruction, ovarian cancer, Peritoneal cancer, Fallopian Tube cancer
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Slow accrual
- Enrolment
- 1 participants (actual)
- Lead sponsor
- University Health Network, TorontoUniversity, hospital or other
- Study start
- Feb 2010
- Primary completion
- Jun 2012 (actual)
- Study completion
- Jun 2012 (actual)
- First posted
- 9 Mar 2010 (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.
The best way to treat MBO in patients with ovarian cancer has not been studied enough by trials that assess how more than one treatment arm (surgical, chemotherapeutic, supportive care approaches) affects clinical outcomes like resolution of bowel obstruction, survival, and quality of life. To improve patient outcomes, we must assess which patients will do better with palliative surgery, chemotherapy, or best supportive care. This study will gather safety information, and how reasonable it is to give chemotherapy and BSC to patients with advanced ovarian cancer and MBO who are non-surgical candidates. This study will also look into the effects of chemotherapy and BSC on the quality of life and resolution of bowel obstruction, in hopes to perform future studies that lead to the best management of MBO.
Detailed description
The optimal management of MBO in patients with ovarian cancer has not been defined by proper prospective randomized control trials evaluating the impact of defined multidisciplinary treatment arms (surgical, chemotherapeutic, supportive care approaches) on important clinical outcomes including resolution of bowel obstruction, survival endpoints and validated quality of life outcomes. In order to improve patient outcomes, we must define which patients will benefit from palliative surgery, which patients are appropriate candidates for chemotherapy and which patients will benefit most from best supportive care. This study will determine the safety, feasibility of chemotherapy and BSC in patients with advanced ovarian cancer presenting with MBO who are initially deemed non-surgical candidates and will identify the impact of chemotherapy and BSC on quality of life and resolution of bowel obstruction, in preparation for future prospective randomized studies to determine the optimal management of MBO.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cisplatin | Experimental | Drug: CisplatinCisplatin administered at 60mg/m2 IV on Day 1, every 21 days for 2 cycles. 1. Hesketh Level 5: 5HT3 receptor antagonist IV/po 30-60 mins pre-chemo and Dexamethasone 10-20mg po/IV 30-60 mins pre-chemo; Dexamethasone 4-8mg po BID x 3 days starting 24hours post last dose of chemo; Prochlorperazine 10mg po/IV q4-6h prn, metoclopramide 10-20mg po/iv q6h prn, haloperidol 0.5-2mg po/SC q 8-12 h prn 2. Hydration: Pre-hydration 500-1000cc NS with 10Meq KCl over 2 hours; Infuse Cisplatin in 250-500cc NS over 1 hour; Post-hydration 1000cc NS + 20Meq KCl (+/- 2g MgSO4) over 1 hour |
| Paclitaxel | Experimental | Drug: PaclitaxelPaclitaxel administered 80mg/m2 IV on Days 1, 8 and 15, every 21 days for 2 cycles. 1. Suggested prophylaxis for paclitaxel-associated hypersensitivity reactions: Dexamethasone 10-20mg po/IV 30-60 mins pre-chemo; diphenydramine 25-50mg IV 30-60 minutes pre-chemo, ranitidine 50mg IV 30-60 minutes pre-chemo 2. Hesketh Level 2: Prochlorperazine 10mg po/IV q4-6h prn 3. Hydration: Infuse Paclitaxel in 250cc NS over 1 hour |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Hospital admission and diagnosis compatible with Malignant Bowel Obstruction, as defined below:
- Non-surgical candidate
- Ability to understand and the willingness to sign a written informed consent document.
- Patients must be 18 years of age or older.
- ECOG performance status 0, 1 or 2 (Karnofsky > or = 60%) one week prior to admission.
Key exclusion criteria (22 listed)
- Patients diagnosed with MBO caused by malignancy other than primary ovarian cancer.
- Patients diagnosed with MBO who are surgical candidates.
- Patients who are pregnant or breast-feeding.
- Concomitant diagnosis of GI malignancy (platinum ineffective) within past 5 years.
- History of severe hypersensitivity reaction to Cisplatin and Paclitaxel.
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 |
|---|---|---|
| Cisplatin1) Cisplatin administered at 60mg/m2 IV on Day 1, every 21 days for 2 cycles. 1. Hesketh Level 5: 5HT3 receptor antagonist IV/po 30-60 mins pre-chemo and Dexamethasone 10-20mg po/IV 30-60 mins pre-chemo; Dexamethasone 4-8mg po BID x 3 days starting 24hours post last dose of chemo; Prochlorperazine 10mg po/IV q4-6h prn, metoclopramide 10-20mg po/iv q6h prn, haloperidol 0.5-2mg po/SC q 8-12 h prn 2. Hydration: Pre-hydration 500-1000cc NS with 10Meq KCl over 2 hours; Infuse Cisplatin in 250-500cc NS over 1 hour; Post-hydration 1000cc NS + 20Meq KCl (+/- 2g MgSO4) over 1 hour | Drug | Cisplatin |
| Paclitaxel2) Paclitaxel administered 80mg/m2 IV on Days 1, 8 and 15, every 21 days for 2 cycles. 1. Suggested prophylaxis for paclitaxel-associated hypersensitivity reactions: Dexamethasone 10-20mg po/IV 30-60 mins pre-chemo; diphenydramine 25-50mg IV 30-60 minutes pre-chemo, ranitidine 50mg IV 30-60 minutes pre-chemo 2. Hesketh Level 2: Prochlorperazine 10mg po/IV q4-6h prn 3. Hydration: Infuse Paclitaxel in 250cc NS over 1 hour | Drug | Paclitaxel |
Primary outcome
Overall Safety Profile
Time frame: Day 1 of treatment until resolution of symptoms
Type, frequency, severity (NCI CTCAE v.3.0.1) and relationship to trial treatment of adverse events and laboratory abnormalities. Frequency and severity of adverse events will be tabulated using counts and proportions detailing frequently occurring, serious and severe events of interest.
Quality of Life Scores at Baseline, Day 30 and Day 90
Time frame: Day 1 of treatment until resolution of symptoms
Quality of life scores will be tabulated using counts and summary statistics. We hypothesize that at 30 days from treatment, there may be no improvement in quality of life scores compared to baseline. We hypothesize that at 90 days from treatment, there will be an improvement in quality of life scores from baseline by one third standard deviation. Paired T test and Mixed model will be used to make the comparison over different time period.
Time to Resolution of Bowel Obstruction
Time frame: Day 1 of treatment until resolution of symptoms
Time to resolution of bowel obstruction and time to recurrence of bowel obstruction will be assessed using summary statistics including mean, median, counts and proportion, to summarize the patients.
2 secondary outcomes
Survival
Time frame: 30 days, 60 days, and 90 days from treatment start date
Evaluation of Toxicity
Time frame: Time of consent until resolution of symptoms
Results and safety
The study was stopped early (reason given: Slow accrual). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Feb 2019.
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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.
Amit Oza principal investigator
Princess Margaret Hospital, Canada
Nicole Chau principal investigator
Princess Margaret Hospital, Canada
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 Cisplatin and Paclitaxel in people with Ovarian Cancer and Peritoneal Cancer, run by University Health Network, Toronto at 1 site in Canada.
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 22 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: stopped early, as of the sponsor's last update on 15 Feb 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 Canada. 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?
The study was stopped early (reason given: Slow accrual). Results are not available in the source record.
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 Safety Profile (time frame: Day 1 of treatment until resolution of symptoms). The study lists 3 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 15 Feb 2019.