Ovarian CancerPhase 2NCT00002487
Methotrexate Plus Dipyridamole in Treating Patients With Advanced Ovarian Cancer
A Phase 2 study testing dipyridamole and methotrexate in people with Ovarian Cancer, run by Ottawa Regional Cancer Centre at 2 sites in Canada.
Trial summary
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Dipyridamole may increase the effectiveness of methotrexate and kill more tumor cells. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Ovarian Cancer
- What is being tested?
- dipyridamole and methotrexate
- How many people
- Not given
- Where
- 2 sitesCanada
- Study dates
- Jul 1991to not given
- 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
- Women only
- No healthy volunteers
- Adult, Older adult
DISEASE CHARACTERISTICS: Histologically proven, Stage III/IV ovarian carcinoma that is refractory or recurrent within 1 year of complete response to intraperitoneal or intravenous platinum-based chemotherapy Debulking surgery must have been considered at the completion of prior chemotherapy (failure to debulk does not exclude) Clinical or radiographic evidence of advanced, predominantly peritoneal disease on physical exam, CT or MRI scan, exploratory laparotomy, or peritoneal cytology or by elevated CA-125 (above 35 units in Ottawa Civic or General Hospitals) required Disease limited to peritoneal cavity not required, but peritoneal disease should constitute the main life-threatening or symptom-producing component Good distribution of contrast medium throughout peritoneal cavity on CT of abdomen and pelvis required Measurable, evaluable, or unevaluable disease of any size acceptable
PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Not specified Life expectancy: More than 2 months Hematopoietic: WBC at least 3,000 Platelets at least 100,000 Hepatic: Bilirubin less than 3 X ULN SGOT less than 3 x ULN Renal: Creatinine less than 1.7 mg/dl (150 micromoles/liter) BUN less than 42 mg/dl (15 mmoles/liter) Other: No requirement for DP or MTX or any medication known to interact with DP, (i.e., antiplatelet or anticoagulant drugs) or MTX (i.e., chemotherapeutic agents) No second malignancy other than basal cell carcinoma of the skin
PRIOR CONCURRENT THERAPY: Recovery from toxicities of prior therapy required Biologic therapy: Not specified Chemotherapy: Prior platinum-based chemotherapy required No concurrent chemotherapy Endocrine therapy: Not specified Radiotherapy: No prior abdominopelvic or pelvic radiotherapy No concurrent peritoneal radiotherapy Surgery: See Disease Characteristics Other: No concurrent antiplatelet or vasodilatory agents
Trial locations and contacts
2 sites in 1 country.
Canada2 sites
Ottawa Regional Cancer Center - General Division
Ottawa, Ontario, K1H 8L6
Ottawa Regional Cancer Centre - Civic Campus
Ottawa, Ontario, K1Y 4K7
About this study
Official title: INTRAPERITONEAL METHOTREXATE AND DIPYRIDAMOLE AS SALVAGE TREATMENT FOR ADVANCED OVARIAN CARCINOMA
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Dipyridamole may increase the effectiveness of methotrexate and kill more tumor cells.
PURPOSE: Phase II trial to study the effectiveness of combining methotrexate and dipyridamole in treating patients with advanced ovarian cancer that is recurrent after or refractory to cisplatin-based chemotherapy.
Read the detailed description
OBJECTIVES: I. Determine the clinical complete and partial response rate, pathological complete response rate, disease-free survival, and duration of response produced by intraperitoneal dipyridamole/methotrexate (DP/MTX) administered as a 7-day continuous infusion in patients with advanced ovarian carcinoma that is recurrent following or refractory to cisplatin-based chemotherapy. II. Determine the peritoneal and systemic toxicity of DP/MTX.
OUTLINE: Nonrandomized study. Single-Agent Chemotherapy with Chemopotentiation. Methotrexate, MTX, NSC-740; with Dipyridamole, DP, NSC-515776.
PROJECTED ACCRUAL: Up to 40 evaluable patients in each category (prior intraperitoneal vs. prior intravenous platinum-based chemotherapy) will be studied. If no responses are seen in the first 20 patients in either category, accrual to that category will cease. An accrual rate of 15 patients/year is anticipated.
- Conditions
- Ovarian Cancer
- Being tested
- dipyridamole, methotrexate
- Keywords
- recurrent ovarian epithelial cancer
- Medical subject headings
- Ovarian Neoplasms, Carcinoma, Ovarian Epithelial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
dipyridamoleDrug
methotrexateDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2004 (estimated)
- Study startJul 1991
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.
- 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
Sponsor and investigators
- Lead sponsor
- Ottawa Regional Cancer Centre
- Sponsor type
- University, hospital or other
- Investigators
- Rakesh Goel, MD, FRCPC, Study chair, Ottawa Regional Cancer Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00002487
- Sponsor's protocol ID
- CDR0000077374
- Other IDs
- CAN-OTT-9017, NCI-V92-0012
- Status last verified
- Apr 2000
- First submitted
- 1 Nov 1999
- Last updated
- 17 Sep 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- INTRAPERITONEAL METHOTREXATE AND DIPYRIDAMOLE AS SALVAGE TREATMENT FOR ADVANCED OVARIAN CARCINOMA
- ClinicalTrials.gov ID
- NCT00002487
- Acronym / sponsor ID
- CDR0000077374
- Conditions
- Ovarian Cancer
- Keywords
- recurrent ovarian epithelial cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Lead sponsor
- Ottawa Regional Cancer CentreUniversity, hospital or other
- Study start
- Jul 1991
- First posted
- 30 Aug 2004 (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: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Dipyridamole may increase the effectiveness of methotrexate and kill more tumor cells.
PURPOSE: Phase II trial to study the effectiveness of combining methotrexate and dipyridamole in treating patients with advanced ovarian cancer that is recurrent after or refractory to cisplatin-based chemotherapy.
Detailed description
OBJECTIVES: I. Determine the clinical complete and partial response rate, pathological complete response rate, disease-free survival, and duration of response produced by intraperitoneal dipyridamole/methotrexate (DP/MTX) administered as a 7-day continuous infusion in patients with advanced ovarian carcinoma that is recurrent following or refractory to cisplatin-based chemotherapy. II. Determine the peritoneal and systemic toxicity of DP/MTX.
OUTLINE: Nonrandomized study. Single-Agent Chemotherapy with Chemopotentiation. Methotrexate, MTX, NSC-740; with Dipyridamole, DP, NSC-515776.
PROJECTED ACCRUAL: Up to 40 evaluable patients in each category (prior intraperitoneal vs. prior intravenous platinum-based chemotherapy) will be studied. If no responses are seen in the first 20 patients in either category, accrual to that category will cease. An accrual rate of 15 patients/year is anticipated.
Study design
- Primary purpose
- Treatment
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- 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 |
|---|---|---|
| dipyridamole | Drug | – |
| methotrexate | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Sep 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.
Rakesh Goel, MD, FRCPC study chair
Ottawa Regional Cancer Centre
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing dipyridamole and methotrexate in people with Ovarian Cancer, run by Ottawa Regional Cancer Centre at 2 sites in Canada.
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: status not confirmed, as of the sponsor's last update on 17 Sep 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 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?
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.
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 17 Sep 2013.