Lung CancerPhase 3NCT00003011
Marimastat Following Chemotherapy in Treating Patients With Small Cell Lung Cancer
A Phase 3 study testing marimastat in people with Lung Cancer, run by NCIC Clinical Trials Group at 38 sites in Canada.
Trial summary
RATIONALE: Marimastat may stop the growth of lung cancer by stopping blood flow to the tumor. It is not yet known if marimastat is an effective treatment for small cell lung cancer. Read more about this study
- Who is it for?
- Ages 16 to 120 years
- Conditions the study is for
- Lung Cancer
- What is being tested?
- marimastat
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 555 participants
- Where
- 38 sitesCanada
- Study dates
- 31 Jan 1997to 15 Dec 2008
- Phase
- Phase 3
- 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 16 to 120 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
DISEASE CHARACTERISTICS: Histologically or cytologically proven small cell lung cancer Complete response (CR) or partial response (PR) following first line chemotherapy required Chest x-ray showing CR or PR required. No documented prior brain metastases
PATIENT CHARACTERISTICS: Age: 16 and over Performance status: ECOG 0-2 Life expectancy: At least 12 weeks Hematopoietic: Not specified Hepatic: Not specified Renal: Not specified Other: Not pregnant or nursing Effective contraception use by men or women of reproductive potential No prior malignancies within 5 years except: Adequately treated nonmelanomatous skin cancer Adequately treated carcinoma in situ of the cervix No other concurrent malignancies No prior diagnosis of breast cancer, melanoma, or hypernephroma No major medical illness that would preclude prolonged administration of marimastat or required follow up No active peptic ulceration or symptoms suggestive of this diagnosis No grade 3 or 4 musculoskeletal disorders
PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: One prior induction combination chemotherapy regimen required Must be completed prior to randomization Hematologically recovered before randomization Minimum of 4 cycles required No change in regimen due to progression No chemotherapy within 28 days prior to randomization if thoracic radiation is given prior to or concurrent with chemotherapy No prior marimastat Endocrine therapy: Not specified Radiotherapy: Prior radiotherapy allowed Must be completed prior to randomization Last dose of radiation treatment must be within 7-14 days prior to randomization if thoracic radiation and/or prophylactic cranial irradiation is given after completion of chemotherapy If severe esophagitis precludes administration of oral medication, randomization may be within 21 days after radiation therapy Surgery: No surgery within 2 weeks prior to randomization Prior complete resection of tumor allowed Other: No other investigational agents within 4 weeks prior to study, and none planned No concurrent coumarin anticoagulants and no coumarin anticoagulants within 4 weeks prior to randomization No concurrent antitumor treatment
Trial locations and contacts
38 sites in 1 country.
38 sites in 1 country
Canada38 sites
William Osler Health Centre
Brampton, Ontario, L6W 2Z8
Cross Cancer Institute
Edmonton, Alberta, T6G 1Z2
CHUS-Hopital Fleurimont
Fleurimont, Quebec, J1H 5N4
Northeastern Ontario Regional Cancer Centre, Sudbury
Greater Sudbury, Ontario, P3E 5J1
Nova Scotia Cancer Centre
Halifax, Nova Scotia, B3H 1V7
Hamilton Regional Cancer Centre
Hamilton, Ontario, L8V 5C2
Trillium Health Centre
Mississauga, Ontario, L5B 1B8
Credit Valley Hospital
Mississauga, Ontario, L5M 2N1
Moncton Hospital
Moncton, New Brunswick, E1C 6ZB
Doctor Leon Richard Oncology Centre
Moncton, New Brunswick, E1C 8X3
Centre Hospitalier de l'Universite de Montreal
Montreal, Quebec, H2L-4M1
McGill University
Montreal, Quebec, H2W 1S6
Hopital Du Sacre-Coeur de Montreal
Montreal, Quebec, H4J 1C5
York County Hospital
Newmarket, Ontario, L3Y 2P9
North York General Hospital, Ontario
North York, Ontario, M2E 1K1
Lakeridge Health Oshawa
Oshawa, Ontario, L1G 2B9
Ottawa Regional Cancer Centre - General Campus
Ottawa, Ontario, K1H 1C4
Penticton Regional Hospital
Penticton, British Columbia, V2A 3G6
Peterborough Oncology Clinic
Peterborough, Ontario, K9H 7B6
Hopital du Saint-Sacrament, Quebec
Québec, Quebec, G1S 4L8
Allan Blair Cancer Centre
Regina, Saskatchewan, S4T 7T1
Saint John Regional Hospital
Saint John, New Brunswick, E2L 4L2
Saskatoon Cancer Centre
Saskatoon, Saskatchewan, S7N 4H4
Hotel Dieu Health Sciences Hospital - Niagara
St. Catharines, Ontario, L2R 5K3
Newfoundland Cancer Treatment and Research Foundation
St. John's, Newfoundland and Labrador, A1B 3V6
L'Hopital Laval
Ste-Foy, Quebec, G1V 4G5
Northwestern Ontario Regional Cancer Centre, Thunder Bay
Thunder Bay, Ontario, P7A 7T1
Toronto East General Hospital
Toronto, Ontario, M4C 3E7
Toronto Sunnybrook Regional Cancer Centre
Toronto, Ontario, M4N 3M5
St. Michael's Hospital - Toronto
Toronto, Ontario, M5B 1W8
Mount Sinai Hospital - Toronto
Toronto, Ontario, M5G 1X5
Toronto General Hospital
Toronto, Ontario, M5G 2C4
Saint Joseph's Health Centre - Toronto
Toronto, Ontario, M6R 1B5
British Columbia Cancer Agency
Vancouver, British Columbia, V5Z 4E6
British Columbia Cancer Agency - Vancouver Island Cancer Centre
Victoria, British Columbia, V8R 6V5
Humber River Regional Hospital
Weston, Ontario, M9N 1N8
Cancer Care Ontario - Windsor Regional Cancer Centre
Windsor, Ontario, N8W 2X3
CancerCare Manitoba
Winnipeg, Manitoba, R3E 0V9
About this study
Official title: A Phase III Study of Marimastat in Patients With Small Cell Lung Cancer Following a Response to First Line Chemotherapy
RATIONALE: Marimastat may stop the growth of lung cancer by stopping blood flow to the tumor. It is not yet known if marimastat is an effective treatment for small cell lung cancer.
PURPOSE: Randomized phase III trial to compare the effectiveness of marimastat with a placebo following chemotherapy in treating patients who have small cell lung cancer.
Read the detailed description
OBJECTIVES: I. Determine whether treatment with the oral matrix metalloproteinase inhibitor (MMPI) marimastat prolongs overall survival and time to progression in patients with small cell lung cancer who have achieved complete or partial remission after first line chemotherapy, with or without radiotherapy. II. Determine the tolerability and toxicity of prolonged administration of marimastat in patients with small cell lung cancer. III. Determine the effect of prolonged administration of marimastat on the quality of life of patients with small cell lung cancer.
OUTLINE: This is a randomized, double blind, multicenter, placebo controlled study. Patients are stratified by stage of disease at diagnosis, response to prior chemotherapy/radiotherapy, type of thoracic radiotherapy, and cooperative group. Patients are randomized into two groups. Half of the patients take marimastat orally twice a day (breakfast and evening meal); the other half take placebo orally twice a day (breakfast and evening meal). Treatment continues for 2 years or until documented disease recurrence or progression and institution of further anticancer treatment, occurrence of unacceptable toxicity, initiation of anticoagulant treatment, or development of intercurrent illness. All patients are followed every 6 months until death.
PROJECTED ACCRUAL: The planned sample size is 360, with an equal number of patients in both arms, accrued at a rate of 240 responders per year (resulting in an accrual period of approximately 1.5 years). The total duration of the study is estimated as 2.3 years.
- Conditions
- Lung Cancer
- Being tested
- marimastat, Placebo
- Keywords
- recurrent small cell lung cancer
- Medical subject headings
- Lung Neoplasms, Small Cell Lung Carcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
marimastatDrug
10 mg PO BID
PlaceboDrug
10 mg PO BID
| Study group | Role | What they receive |
|---|---|---|
| Marmistat | Active comparator | 10 mg PO BID Receives: Drug: marimastat |
| Placebo | Placebo comparator | 10 mg PO BID Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Survival
To determine whether treatment with the oral metalloproteinase inhibitor marimastat prolongs overall survival and time to progression in patients with small cell lung cancer who have achieved complete or partial remission after first line chemotherapy (+I- radiotherapy).
Measured: 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Feb 2004 (estimated)
- Study start31 Jan 1997
- Primary completion13 Feb 2001
- Study completion15 Dec 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Lung 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 555 participants (actual)
Sponsor and investigators
- Lead sponsor
- NCIC Clinical Trials Group
- Sponsor type
- Research network
- Responsible party
- Sponsor
- Investigators
- Giuseppe Giaccone, MD, PhD, Study chair, Universitair Ziekenhuis BrusselFrances A. Shepherd, MD, Study chair, Princess Margaret Hospital, Canada
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00003011
- Sponsor's protocol ID
- BR12
- Other IDs
- EORTC-08962, CAN-NCIC-BR12, CDR0000065589
- Status last verified
- Apr 2020
- First submitted
- 1 Nov 1999
- Last updated
- 3 Apr 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Huisman C, Postmus PE, Giaccone G, Smit EF. Second-line chemotherapy and its evaluation in small cell lung cancer. Cancer Treat Rev. 1999 Aug;25(4):199-206. doi: 10.1053/ctrv.1999.0125.
PubMed 10448128Shepherd FA, Giaccone G, Seymour L, Debruyne C, Bezjak A, Hirsh V, Smylie M, Rubin S, Martins H, Lamont A, Krzakowski M, Sadura A, Zee B. Prospective, randomized, double-blind, placebo-controlled trial of marimastat after response to first-line chemotherapy in patients with small-cell lung cancer: a trial of the National Cancer Institute of Canada-Clinical Trials Group and the European Organization for Research and Treatment of Cancer. J Clin Oncol. 2002 Nov 15;20(22):4434-9. doi: 10.1200/JCO.2002.02.108.
PubMed 12431965
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase III Study of Marimastat in Patients With Small Cell Lung Cancer Following a Response to First Line Chemotherapy
- ClinicalTrials.gov ID
- NCT00003011
- Acronym / sponsor ID
- BR12
- Conditions
- Lung Cancer
- Keywords
- recurrent small cell lung cancer
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 555 participants (actual)
- Lead sponsor
- NCIC Clinical Trials GroupResearch network
- Study start
- 31 Jan 1997 (actual)
- Primary completion
- 13 Feb 2001 (actual)
- Study completion
- 15 Dec 2008 (actual)
- First posted
- 16 Feb 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: Marimastat may stop the growth of lung cancer by stopping blood flow to the tumor. It is not yet known if marimastat is an effective treatment for small cell lung cancer.
PURPOSE: Randomized phase III trial to compare the effectiveness of marimastat with a placebo following chemotherapy in treating patients who have small cell lung cancer.
Detailed description
OBJECTIVES: I. Determine whether treatment with the oral matrix metalloproteinase inhibitor (MMPI) marimastat prolongs overall survival and time to progression in patients with small cell lung cancer who have achieved complete or partial remission after first line chemotherapy, with or without radiotherapy. II. Determine the tolerability and toxicity of prolonged administration of marimastat in patients with small cell lung cancer. III. Determine the effect of prolonged administration of marimastat on the quality of life of patients with small cell lung cancer.
OUTLINE: This is a randomized, double blind, multicenter, placebo controlled study. Patients are stratified by stage of disease at diagnosis, response to prior chemotherapy/radiotherapy, type of thoracic radiotherapy, and cooperative group. Patients are randomized into two groups. Half of the patients take marimastat orally twice a day (breakfast and evening meal); the other half take placebo orally twice a day (breakfast and evening meal). Treatment continues for 2 years or until documented disease recurrence or progression and institution of further anticancer treatment, occurrence of unacceptable toxicity, initiation of anticoagulant treatment, or development of intercurrent illness. All patients are followed every 6 months until death.
PROJECTED ACCRUAL: The planned sample size is 360, with an equal number of patients in both arms, accrued at a rate of 240 responders per year (resulting in an accrual period of approximately 1.5 years). The total duration of the study is estimated as 2.3 years.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Marmistat | Active comparator | Drug: marimastat10 mg PO BID |
| Placebo | Placebo comparator | Drug: Placebo10 mg PO BID |
Who may qualify
- Ages
- 16 to 120 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, 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 |
|---|---|---|
| marimastat10 mg PO BID | Drug | Marmistat |
| Placebo10 mg PO BID | Drug | Placebo |
Primary outcome
Overall Survival
Time frame: 4 years
To determine whether treatment with the oral metalloproteinase inhibitor marimastat prolongs overall survival and time to progression in patients with small cell lung cancer who have achieved complete or partial remission after first line chemotherapy (+I- radiotherapy).
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 3 Apr 2020.
- Background: PubMed 10448128Huisman C, Postmus PE, Giaccone G, Smit EF. Second-line chemotherapy and its evaluation in small cell lung cancer. Cancer Treat Rev. 1999 Aug;25(4):199-206. doi: 10.1053/ctrv.1999.0125.
- Results publication: PubMed 12431965Shepherd FA, Giaccone G, Seymour L, Debruyne C, Bezjak A, Hirsh V, Smylie M, Rubin S, Martins H, Lamont A, Krzakowski M, Sadura A, Zee B. Prospective, randomized, double-blind, placebo-controlled trial of marimastat after response to first-line chemotherapy in patients with small-cell lung cancer: a trial of the National Cancer Institute of Canada-Clinical Trials Group and the European Organization for Research and Treatment of Cancer. J Clin Oncol. 2002 Nov 15;20(22):4434-9. doi: 10.1200/JCO.2002.02.108.
- Individual participant dataSharing planned: No
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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.
Giuseppe Giaccone, MD, PhD study chair
Universitair Ziekenhuis Brussel
Frances A. Shepherd, MD study chair
Princess Margaret Hospital, Canada
38 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing marimastat in people with Lung Cancer, run by NCIC Clinical Trials Group at 38 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: finished, as of the sponsor's last update on 3 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 38 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. Some participants in this study may receive a placebo. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Overall Survival (time frame: 4 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00003011, which also lists 2 linked publications.
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 3 Apr 2020.