Fallopian Tube CancerPhase 2NCT00030446
Erlotinib and Carboplatin in Recurrent Ovarian, Fallopian Tube, or Primary Peritoneal Cancer
A Phase 2 study testing carboplatin and erlotinib hydrochloride in people with Fallopian Tube Cancer and Ovarian Cancer, run by NCIC Clinical Trials Group at 8 sites in Canada.
Trial summary
RATIONALE: Biological therapies such as erlotinib may interfere with the growth of tumor cells and slow the growth of the tumor. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining erlotinib with carboplatin may kill more tumor cells. Read more about this study
- Who is it for?
- Ages 18 to 120 years, women only
- Conditions the study is for
- Fallopian Tube Cancer, Ovarian Cancer, Peritoneal Cavity Cancer
- What is being tested?
- carboplatin and erlotinib hydrochloride
- How many people
- 50 participants
- Where
- 8 sitesCanada
- Study dates
- 10 Jan 2002to 21 Dec 2009
- 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 120 years
- Women only
- No healthy volunteers
- Adult, Older adult
DISEASE CHARACTERISTICS:
- Histologically confirmed recurrent ovarian epithelial, fallopian tube, or primary peritoneal cancer for which no standard curative therapy exists
- At least 1 measurable lesion
- At least 20 mm by x-ray, non-spiral CT scan, or physical exam OR at least 10 mm by spiral CT scan
- Ascites and bone metastases not considered measurable disease
- No abdominal adenocarcinoma of unknown origin or borderline ovarian tumor
- No elevated CA 125 as only evidence of disease
- At least 1 but no more than 2 prior chemotherapy regimens required
- First regimen must have contained cisplatin or carboplatin
- Switching platinum compounds due to disease progression or failure to respond is considered 2 regimens
- Same regimen as first- and second-line therapy is considered 2 regimens
- Responded to prior platinum-based first-line chemotherapy
- No platinum-refractory disease
- No known brain metastases
PATIENT CHARACTERISTICS:
Age:
- 18 and over
Performance status:
- ECOG 0-2
Life expectancy:
- At least 12 weeks
Hematopoietic:
- Absolute granulocyte count at least 1,500/mm^3
- Platelet count at least 100,000/mm^3
Hepatic:
- Bilirubin no greater than upper limit of normal (ULN)
- AST/ALT no greater than 2.5 times ULN
Renal:
- Creatinine no greater than ULN
Cardiovascular:
- No symptomatic congestive heart failure
- No unstable angina
- No cardiac arrhythmia
Gastrointestinal:
- See Surgery
- No GI tract disease resulting in an inability to take oral medication or requiring IV alimentation
- No uncontrolled inflammatory GI disease (e.g., Crohn's disease or ulcerative colitis)
- No active peptic ulcer disease
Ophthalmic:
- No ocular inflammation or infection
- No significant ophthalmologic abnormalities, including:
- History of dry eye syndrome, Sjögren's syndrome, or keratoconjunctivitis sicca
- Severe exposure keratopathy
- Disorders that might increase the risk for epithelium-related complications (e.g., bullous keratopathy, aniridia, severe chemical burns, or neutrophilic keratitis)
- Congenital abnormality (e.g., Fuch's dystrophy)
- Abnormal slit-lamp examination using a vital dye (e.g., fluorescein or Bengal-Rose)
- Abnormal corneal sensitivity test (e.g., Schirmer test or similar tear production test)
Other:
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- No prior allergic reaction to compounds of similar chemical or biological composition to erlotinib
- No other serious illness, medical condition, or significant neurologic or psychiatric disorder that would preclude study therapy
- No active uncontrolled infection
- No grade 3 or greater drug-related neurotoxicity
- No other malignancy within the past 5 years except adequately treated nonmelanoma skin cancer or curatively treated carcinoma in situ of the cervix
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- Not specified
Chemotherapy:
- See Disease Characteristics
- At least 4 weeks since prior chemotherapy (6 weeks for mitomycin or nitrosoureas)
Endocrine therapy:
- Not specified
Radiotherapy:
- At least 4 weeks since prior radiotherapy (except low-dose palliative radiotherapy) and recovered
Surgery:
- At least 3 weeks since prior major surgery (wound healing must have occurred)
- No prior surgical procedures affecting gastrointestinal (GI) absorption
- No concurrent ophthalmic surgery
Other:
- No prior therapy targeting epidermal growth factor receptor
- No other concurrent anticancer therapy
- No other concurrent investigational agents
- Concurrent oral anticoagulants (e.g., warfarin) allowed provided INR is monitored
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
Canada8 sites
Tom Baker Cancer Center - Calgary
Calgary, Alberta, T2N 4N2
Queen Elizabeth II Health Science Centre
Halifax, Nova Scotia, B3H 2Y9
Margaret and Charles Juravinski Cancer Centre
Hamilton, Ontario, L8V 5C2
British Columbia Cancer Agency - Centre for the Southern Interior
Kelowna, British Columbia, V1Y 5L3
Cancer Care Ontario-London Regional Cancer Centre
London, Ontario, N6A 4L6
Hopital Notre- Dame du CHUM
Montreal, Quebec, H4L 2M1
Princess Margaret Hospital
Toronto, Ontario, M5G 2M9
British Columbia Cancer Agency
Vancouver, British Columbia, V5Z 4E6
About this study
Official title: A Phase II Study Of OSI-774 (NSC 718781) Given In Combination With Carboplatin In Patients With Recurrent Epithelial Ovarian Cancer
RATIONALE: Biological therapies such as erlotinib may interfere with the growth of tumor cells and slow the growth of the tumor. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining erlotinib with carboplatin may kill more tumor cells.
PURPOSE: Phase II trial to study the effectiveness of combining erlotinib and carboplatin in treating patients who have recurrent ovarian, fallopian tube, or primary peritoneal cancer.
Read the detailed description
OBJECTIVES:
- Determine the response rate in patients with recurrent ovarian epithelial, fallopian tube, or primary peritoneal cancer treated with erlotinib and carboplatin.
- Determine the duration of stable disease, time to progression, and response duration in patients treated with this regimen.
- Determine the toxicity of this regimen in these patients.
- Correlate the level of epidermal growth factor receptor tumor expression with objective tumor response in patients treated with this regimen.
OUTLINE: This is a multicenter study. Patients are stratified according to response to prior platinum-containing therapy (platinum-sensitive, defined as 6 months or more since prior therapy with platinum agent [closed to accrual as of 2/13/2004], vs platinum-resistant, defined as less than 6 months since prior therapy with platinum agent).
Patients receive carboplatin IV over 30 minutes on day 1 and oral erlotinib once daily on days 1-21. Treatment repeats every 21 days for up to 6 courses. After the completion of 6 courses of therapy, patients with responsive or stable disease may continue to receive erlotinib and carboplatin in the absence of disease progression or unacceptable toxicity.
Patients are followed at 4 weeks and then every 3 months thereafter.
PROJECTED ACCRUAL: A total of 23-60 patients (8-30 for platinum-sensitive stratum [closed to accrual as of 2/13/2004] and 15-30 for platinum-resistant stratum) will be accrued for this study within 15-23 months.
- Being tested
- carboplatin, erlotinib hydrochloride
- Keywords
- recurrent ovarian epithelial cancer, fallopian tube cancer, peritoneal cavity cancer
- Medical subject headings
- Fallopian Tube Neoplasms, Ovarian Neoplasms, Carcinoma, Ovarian Epithelial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
carboplatinDrug
erlotinib hydrochlorideDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2003 (estimated)
- Study start10 Jan 2002
- Primary completion11 Feb 2005
- Study completion21 Dec 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Fallopian Tube 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
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- NCIC Clinical Trials Group
- Sponsor type
- Research network
- Responsible party
- Sponsor
- Investigators
- Hal W. Hirte, MD, FRCP(C), Study chair, Margaret and Charles Juravinski Cancer Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00030446
- Sponsor's protocol ID
- I149
- Other IDs
- CAN-NCIC-149, CDR0000069166
- Status last verified
- Apr 2020
- First submitted
- 14 Feb 2002
- Last updated
- 8 Apr 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Hirte H, Oza A, Hoskins P, et al.: Phase II study of OSI-774 given in combination with carboplatin in patients (pts) with recurrent epithelial ovarian cancer (EOC): NCIC CTG IND.149. [Abstract] European Journal of Cancer Supplements 1 (5): A-159, S51, 2003.
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Study Of OSI-774 (NSC 718781) Given In Combination With Carboplatin In Patients With Recurrent Epithelial Ovarian Cancer
- ClinicalTrials.gov ID
- NCT00030446
- Acronym / sponsor ID
- I149
- Keywords
- recurrent ovarian epithelial cancer, fallopian tube cancer, peritoneal cavity cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- NCIC Clinical Trials GroupResearch network
- Study start
- 10 Jan 2002 (actual)
- Primary completion
- 11 Feb 2005 (actual)
- Study completion
- 21 Dec 2009 (actual)
- First posted
- 27 Jun 2003 (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: Biological therapies such as erlotinib may interfere with the growth of tumor cells and slow the growth of the tumor. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining erlotinib with carboplatin may kill more tumor cells.
PURPOSE: Phase II trial to study the effectiveness of combining erlotinib and carboplatin in treating patients who have recurrent ovarian, fallopian tube, or primary peritoneal cancer.
Detailed description
OBJECTIVES:
- Determine the response rate in patients with recurrent ovarian epithelial, fallopian tube, or primary peritoneal cancer treated with erlotinib and carboplatin.
- Determine the duration of stable disease, time to progression, and response duration in patients treated with this regimen.
- Determine the toxicity of this regimen in these patients.
- Correlate the level of epidermal growth factor receptor tumor expression with objective tumor response in patients treated with this regimen.
OUTLINE: This is a multicenter study. Patients are stratified according to response to prior platinum-containing therapy (platinum-sensitive, defined as 6 months or more since prior therapy with platinum agent [closed to accrual as of 2/13/2004], vs platinum-resistant, defined as less than 6 months since prior therapy with platinum agent).
Patients receive carboplatin IV over 30 minutes on day 1 and oral erlotinib once daily on days 1-21. Treatment repeats every 21 days for up to 6 courses. After the completion of 6 courses of therapy, patients with responsive or stable disease may continue to receive erlotinib and carboplatin in the absence of disease progression or unacceptable toxicity.
Patients are followed at 4 weeks and then every 3 months thereafter.
PROJECTED ACCRUAL: A total of 23-60 patients (8-30 for platinum-sensitive stratum [closed to accrual as of 2/13/2004] and 15-30 for platinum-resistant stratum) will be accrued for this study within 15-23 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 120 years
- 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 |
|---|---|---|
| carboplatin | Drug | – |
| erlotinib hydrochloride | Drug | – |
Primary outcome
Not reported in the source record.
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 8 Apr 2020.
- Results publicationHirte H, Oza A, Hoskins P, et al.: Phase II study of OSI-774 given in combination with carboplatin in patients (pts) with recurrent epithelial ovarian cancer (EOC): NCIC CTG IND.149. [Abstract] European Journal of Cancer Supplements 1 (5): A-159, S51, 2003.
- 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.
Hal W. Hirte, MD, FRCP(C) study chair
Margaret and Charles Juravinski Cancer Centre
8 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 carboplatin and erlotinib hydrochloride in people with Fallopian Tube Cancer and Ovarian Cancer, run by NCIC Clinical Trials Group at 8 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 8 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 8 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?
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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00030446, which also lists 1 linked publication.
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 8 Apr 2020.