Cervical CancerPhase 1NCT00428194
Erlotinib, Cisplatin, and Radiation Therapy in Treating Patients With Stage IB-Stage IVA Cervical Cancer
A Phase 1 study testing cisplatin, erlotinib hydrochloride and radiation therapy in people with Cervical Cancer, run by Masonic Cancer Center, University of Minnesota at 1 site in United States.
Trial summary
RATIONALE: Erlotinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Cervical Cancer
- What is being tested?
- cisplatin, erlotinib hydrochloride and radiation therapy
- Type of treatment
- Pill or oral medicine, Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2007to Mar 2008
- Phase
- Phase 1
- 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
Who may be able to join
- Diagnosis of squamous cell carcinoma of the cervix
- Stage IB-IVA disease
- Scheduled to undergo standard radiotherapy and receive weekly cisplatin
- ECOG performance status 0-2
- Not pregnant
- Negative pregnancy test
- Fertile patients must use effective contraception during and for ≥ 1 week after completion of study treatment
- Must be able to take oral medication
Who cannot join
- Malabsorption syndrome
- Serious underlying medical condition that would impair the ability of patient to receive treatment
- Known hypersensitivity to erlotinib hydrochloride
- Psychological, familial, sociological, or geographical conditions that would preclude study compliance
- Less than 21 days since prior nonapproved or investigational drugs
- Prior chemotherapy
Show all 16Show fewer
- Prior radiotherapy
- Prior anti-epidermal growth factor receptor treatment
- Prior gastrointestinal surgery that limits absorption (i.e., requiring total parenteral nutrition)
- Concurrent use of any of the following agents and therapies:
- Other antineoplastic or antitumor agents
- Other chemotherapy
- Other investigational agents
- Radiotherapy
- Immunotherapy
- Anticancer hormonal therapy
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Minnesota Cancer Center
Minneapolis, Minnesota, 55455
About this study
Official title: Erlotinib in Combination With Cisplatin as Radiosensitizing Agents in Women Receiving Radiation Therapy for Locally Advanced Squamous Cell Carcinoma of the Cervix; A Phase I Trial
RATIONALE: Erlotinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high-energy x-rays to kill tumor cells. Erlotinib and cisplatin may make tumor cells more sensitive to radiation therapy. Giving erlotinib together with cisplatin and radiation therapy may kill more tumor cells.
PURPOSE: This phase I trial is studying the side effects and best dose of erlotinib when given together with cisplatin and radiation therapy in treating patients with stage IB, stage II, stage III, or stage IVA cervical cancer.
Read the detailed description
OBJECTIVES:
Primary
- Determine the maximum tolerated dose of erlotinib hydrochloride when administered with cisplatin and pelvic radiotherapy in patients with stage IB-IVA squamous cell carcinoma of the cervix.
Secondary
- Determine the toxicity profile of this regimen.
OUTLINE: This is a multicenter, open-label, dose-escalation study of erlotinib hydrochloride.
Patients receive oral erlotinib hydrochloride once daily on days 1-35 and cisplatin IV on days 1, 8, 15, 22, and 29. Patients also undergo radiotherapy daily, 5 days a week, for approximately 5 weeks concurrently with chemotherapy.
Cohorts of 3-6 patients receive escalating doses of erlotinib hydrochloride until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose proceeding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity.
After completion of study treatment, patients are followed at 6 weeks.
- Conditions
- Cervical Cancer
- Being tested
- cisplatin, erlotinib hydrochloride, radiation therapy
- Keywords
- stage IIA cervical cancer, stage IB cervical cancer, stage IIB cervical cancer, stage III cervical cancer, stage IVA cervical cancer, cervical squamous cell carcinoma
- Medical subject headings
- Uterine Cervical Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cisplatinDrug
Also called cisplatinum, CDDP
40 mg/m^2 every 7 days during radiation
erlotinib hydrochlorideDrug
Also called Tarceva(R)
Erlotinib escalating dose per schedule - 100, 125 and 150 mg/m^2 by mouth once a day beginning day 1.
radiation therapyProcedure or surgery
Also called irradiation
standard (fixed) doses of pelvic irradiation (as determined by their radiation oncologist)
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 | Experimental | Erlotinib 100 mg/day by mouth beginning on day 1 of radiotherapy (RT) and cisplatin dosing (40 mg/m^2 intravenous every 7 days during RT) and continuing daily through radiation Receives: Drug: cisplatin; Drug: erlotinib hydrochloride; Procedure: radiation therapy |
| Cohort 2 | Experimental | Erlotinib 125 mg/day by mouth beginning on day 1 of radiotherapy (RT) and cisplatin dosing (40 mg/m^2 intravenous every 7 days during RT) and continuing daily through radiation Receives: Drug: cisplatin; Drug: erlotinib hydrochloride; Procedure: radiation therapy |
| Cohort 3 | Active comparator | Erlotinib 150 mg/day by mouth beginning on day 1 of radiotherapy (RT) and cisplatin dosing (40 mg/m^2 intravenous every 7 days during RT) and continuing daily through radiation Receives: Drug: cisplatin; Drug: erlotinib hydrochloride; Procedure: radiation therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum tolerated dose of erlotinib hydrochloride
Measured: Day 14
Secondary outcomes (1)
Toxicity
Measured: 4-6 Weeks Post Last Study Dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2007 (estimated)
- Study startJan 2007
- Primary completionMar 2008
- Study completionMar 2008
Why it stopped: Withdrawn due to lack of accrual
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cervical CancerStudies of the same condition, open and under way.
- More trials run by Masonic Cancer Center, University of MinnesotaThe 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
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Masonic Cancer Center, University of Minnesota
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Levi S. Downs, MD, Study chair, Masonic Cancer Center, University of Minnesota
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00428194
- Sponsor's protocol ID
- 2006LS019
- Other IDs
- UMN-0604M84827
- Status last verified
- Nov 2017
- First submitted
- 25 Jan 2007
- Last updated
- 29 Nov 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 29 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Erlotinib in Combination With Cisplatin as Radiosensitizing Agents in Women Receiving Radiation Therapy for Locally Advanced Squamous Cell Carcinoma of the Cervix; A Phase I Trial
- ClinicalTrials.gov ID
- NCT00428194
- Acronym / sponsor ID
- 2006LS019
- Conditions
- Cervical Cancer
- Keywords
- stage IIA cervical cancer, stage IB cervical cancer, stage IIB cervical cancer, stage III cervical cancer, stage IVA cervical cancer, cervical squamous cell carcinoma
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Withdrawn due to lack of accrual
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Masonic Cancer Center, University of MinnesotaUniversity, hospital or other
- Study start
- Jan 2007
- Primary completion
- Mar 2008 (actual)
- Study completion
- Mar 2008 (actual)
- First posted
- 29 Jan 2007 (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: Erlotinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high-energy x-rays to kill tumor cells. Erlotinib and cisplatin may make tumor cells more sensitive to radiation therapy. Giving erlotinib together with cisplatin and radiation therapy may kill more tumor cells.
PURPOSE: This phase I trial is studying the side effects and best dose of erlotinib when given together with cisplatin and radiation therapy in treating patients with stage IB, stage II, stage III, or stage IVA cervical cancer.
Detailed description
OBJECTIVES:
Primary
- Determine the maximum tolerated dose of erlotinib hydrochloride when administered with cisplatin and pelvic radiotherapy in patients with stage IB-IVA squamous cell carcinoma of the cervix.
Secondary
- Determine the toxicity profile of this regimen.
OUTLINE: This is a multicenter, open-label, dose-escalation study of erlotinib hydrochloride.
Patients receive oral erlotinib hydrochloride once daily on days 1-35 and cisplatin IV on days 1, 8, 15, 22, and 29. Patients also undergo radiotherapy daily, 5 days a week, for approximately 5 weeks concurrently with chemotherapy.
Cohorts of 3-6 patients receive escalating doses of erlotinib hydrochloride until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose proceeding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity.
After completion of study treatment, patients are followed at 6 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 | Experimental | Drug: cisplatin, Drug: erlotinib hydrochloride, Procedure: radiation therapyErlotinib 100 mg/day by mouth beginning on day 1 of radiotherapy (RT) and cisplatin dosing (40 mg/m^2 intravenous every 7 days during RT) and continuing daily through radiation |
| Cohort 2 | Experimental | Drug: cisplatin, Drug: erlotinib hydrochloride, Procedure: radiation therapyErlotinib 125 mg/day by mouth beginning on day 1 of radiotherapy (RT) and cisplatin dosing (40 mg/m^2 intravenous every 7 days during RT) and continuing daily through radiation |
| Cohort 3 | Active comparator | Drug: cisplatin, Drug: erlotinib hydrochloride, Procedure: radiation therapyErlotinib 150 mg/day by mouth beginning on day 1 of radiotherapy (RT) and cisplatin dosing (40 mg/m^2 intravenous every 7 days during RT) and continuing daily through radiation |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Diagnosis of squamous cell carcinoma of the cervix
- Scheduled to undergo standard radiotherapy and receive weekly cisplatin
- ECOG performance status 0-2
- Not pregnant
- Negative pregnancy test
Key exclusion criteria (16 listed)
- Malabsorption syndrome
- Serious underlying medical condition that would impair the ability of patient to receive treatment
- Known hypersensitivity to erlotinib hydrochloride
- Psychological, familial, sociological, or geographical conditions that would preclude study compliance
- Less than 21 days since prior nonapproved or investigational drugs
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 |
|---|---|---|
| cisplatinAlso: cisplatinum, CDDP40 mg/m^2 every 7 days during radiation | Drug | Cohort 1, Cohort 2, Cohort 3 |
| erlotinib hydrochlorideAlso: Tarceva(R)Erlotinib escalating dose per schedule - 100, 125 and 150 mg/m^2 by mouth once a day beginning day 1. | Drug | Cohort 1, Cohort 2, Cohort 3 |
| radiation therapyAlso: irradiationstandard (fixed) doses of pelvic irradiation (as determined by their radiation oncologist) | Procedure or surgery | Cohort 1, Cohort 2, Cohort 3 |
Primary outcome
Maximum tolerated dose of erlotinib hydrochloride
Time frame: Day 14
1 secondary outcome
Toxicity
Time frame: 4-6 Weeks Post Last Study Dose
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 29 Nov 2017.
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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.
Levi S. Downs, MD study chair
Masonic Cancer Center, University of Minnesota
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing cisplatin, erlotinib hydrochloride and radiation therapy in people with Cervical Cancer, run by Masonic Cancer Center, University of Minnesota 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 8 inclusion and 16 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 29 Nov 2017. 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 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.
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?
Maximum tolerated dose of erlotinib hydrochloride (time frame: Day 14). 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 29 Nov 2017.