Uterine Cervix CancerPhase 1NCT02363829
A Study of Nelfinavir Added to Cisplatin Chemotherapy Concurrent With Pelvic Radiation for Locally Advanced Cervical Cancer (II-IVA)
A Phase 1 study testing Nelfinavir and Cisplatin in people with Uterine Cervix Cancer, run by Abramson Cancer Center at Penn Medicine at 1 site in United States.
Trial summary
Patients 18 years of age and older with clinical stages IIA, IIB, IIIA, IIIB, IVA cervical carcinoma limited to the pelvis will receive twice daily oral nelfinavir (NFV) and weekly IV cisplatin in combination as radiosensitizers with daily whole pelvic external beam and intracavitary radiation brachytherapy. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Uterine Cervix Cancer
- What is being tested?
- Nelfinavir and Cisplatin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2015to 17 Feb 2020
- 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
- All patients with primary, previously untreated, histologically confirmed invasive carcinoma of the uterine cervix (any cell type). Clinical stages IIA, IIB, IIIA, IIIB, IVA. A representative H \& E stained slide showing documentation of the primary invasive cancer is required.
- Patients must have adequate bone marrow, renal and hepatic function:
- Laboratory work must be performed within 30 days prior to start of study treatment.
- ANC ≥ 1,500/μL; Platelet count ≥ 100,000/μL; Creatinine < 2.0 mg/dL; Total Bilirubin ≤ 1.5 times normal; SGOT ≤ 3 times normal.
- Patients with a ECOG/GOG Performance Status of 0, 1, or 2.
- Patients with ureteral obstruction must be treated with stent or nephrostomy tube.
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- Patients of childbearing potential must use an effective form of birth control."Patients receiving oral contraceptives should be instructed that alternate or additional contraceptive measures should be used during therapy with VIRACEPT. "
- Confirmed seronegative HIV status within 3 months prior to start of study treatment.
- Patients must be at least 18 years of age.
- Patients must have signed an approved informed consent and authorization permitting release of personal health information.
Who cannot join
- Patients with Stage IA, IB or IVB disease.
- Patients who have known metastases to other organs outside the radiation field at the time of the original clinical and surgical staging.
- Patients who have received previous pelvic or abdominal radiation, cytotoxic chemotherapy, or previous therapy of any kind for this malignancy.
- Patients with septicemia or severe infection.
- Patients who have circumstances that will not permit completion of this study or the required follow-up.
- Patients who are pregnant at the time of diagnosis and do not wish pregnancy termination prior to initiation of treatment.
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- Patients with renal abnormalities, such as pelvic kidney, horseshoe kidney, or renal transplantation, that would require modification of radiation fields.
- Patients with other concomitant malignancies (with the exception of non-melanoma skin cancer), who had (or have) any evidence of other cancer present within the last 5 years.
- Patients with GI tract disease resulting in an inability to take oral medication, malabsorption syndrome, a requirement for IV alimentation, prior surgical procedures affecting absorption, uncontrolled inflammatory GI disease (e.g., Crohn's, ulcerative colitis).
- Patients with poorly controlled diabetes mellitus despite medication.
- Patients taking anti-arythmic agents such as amiodarone, quinidine, rifampin, ergot derivatives such as ergotamine, St John's Wort, HMG-CoA reductase inhibitors such as lovastatin, neuroleptic such as pimozide, sedatives such as midazolam and triazolam among other CYP3A4 and CYP2C19 substrates.
- Patients with Phenylketonuria
Trial locations and contacts
1 site in 1 country.
United States1 site
Abramson Cancer Center of the University of Pennsylvania
Philadelphia, Pennsylvania, 19104
About this study
Official title: A Phase I Study of Nelfinavir Added to Cisplatin Chemotherapy Concurrent With Pelvic Radiation for Locally Advanced Cervical Cancer (II-IVA)
Patients 18 years of age and older with clinical stages IIA, IIB, IIIA, IIIB, IVA cervical carcinoma limited to the pelvis will receive twice daily oral nelfinavir (NFV) and weekly IV cisplatin in combination as radiosensitizers with daily whole pelvic external beam and intracavitary radiation brachytherapy.
- Conditions
- Uterine Cervix Cancer
- Being tested
- Nelfinavir, Cisplatin
- Keywords
- clinical stages IIA, IIB, IIIA, IIIB, IVA, invasive carcinoma, uterine cervix
- Medical subject headings
- Uterine Cervical Neoplasms, Acidemia, isovaleric
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NelfinavirDrug
CisplatinBiological
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Experimental | Nelfinavir and Cisplatin Receives: Drug: Nelfinavir; Biological: Cisplatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Adverse Events
Measured: 2 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 2015 (estimated)
- Study startFeb 2015
- Primary completion17 Feb 2020
- Study completion17 Feb 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Uterine Cervix CancerStudies of the same condition, open and under way.
- More trials run by Abramson Cancer Center at Penn MedicineThe 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abramson Cancer Center at Penn Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Fiona Simpkins, MD, Principal investigator, Abramson Cancer Center at Penn MedicineLilie Lin, MD, Principal investigator, Abramson Cancer Center at Penn Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02363829
- Sponsor's protocol ID
- UPCC 32814
- Status last verified
- Apr 2020
- First submitted
- 10 Feb 2015
- Last updated
- 6 Apr 2020
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Study of Nelfinavir Added to Cisplatin Chemotherapy Concurrent With Pelvic Radiation for Locally Advanced Cervical Cancer (II-IVA)
- ClinicalTrials.gov ID
- NCT02363829
- Acronym / sponsor ID
- UPCC 32814
- Conditions
- Uterine Cervix Cancer
- Keywords
- clinical stages IIA, IIB, IIIA, IIIB, IVA, invasive carcinoma, uterine cervix
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Abramson Cancer Center at Penn MedicineUniversity, hospital or other
- Study start
- Feb 2015 (actual)
- Primary completion
- 17 Feb 2020 (actual)
- Study completion
- 17 Feb 2020 (actual)
- First posted
- 16 Feb 2015 (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.
Patients 18 years of age and older with clinical stages IIA, IIB, IIIA, IIIB, IVA cervical carcinoma limited to the pelvis will receive twice daily oral nelfinavir (NFV) and weekly IV cisplatin in combination as radiosensitizers with daily whole pelvic external beam and intracavitary radiation brachytherapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment | Experimental | Drug: Nelfinavir, Biological: CisplatinNelfinavir and Cisplatin |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- All patients with primary, previously untreated, histologically confirmed invasive carcinoma of the uterine cervix (any cell type). Clinical stages IIA, IIB, IIIA, IIIB, IVA. A representative H \& E stained slide showing documentation of the primary invasive cancer is required.
- Patients must have adequate bone marrow, renal and hepatic function:
- Laboratory work must be performed within 30 days prior to start of study treatment.
- ANC ≥ 1,500/μL; Platelet count ≥ 100,000/μL; Creatinine < 2.0 mg/dL; Total Bilirubin ≤ 1.5 times normal; SGOT ≤ 3 times normal.
- Patients with a ECOG/GOG Performance Status of 0, 1, or 2.
Key exclusion criteria (12 listed)
- Patients with Stage IA, IB or IVB disease.
- Patients who have known metastases to other organs outside the radiation field at the time of the original clinical and surgical staging.
- Patients who have received previous pelvic or abdominal radiation, cytotoxic chemotherapy, or previous therapy of any kind for this malignancy.
- Patients with septicemia or severe infection.
- Patients who have circumstances that will not permit completion of this study or the required follow-up.
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 |
|---|---|---|
| Nelfinavir | Drug | Treatment |
| Cisplatin | Biological | Treatment |
Primary outcome
Number of Adverse Events
Time frame: 2 years
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 6 Apr 2020.
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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.
Fiona Simpkins, MD principal investigator
Abramson Cancer Center at Penn Medicine
Lilie Lin, MD principal investigator
Abramson Cancer Center at Penn Medicine
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 Nelfinavir and Cisplatin in people with Uterine Cervix Cancer, run by Abramson Cancer Center at Penn Medicine 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 10 inclusion and 12 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: finished, as of the sponsor's last update on 6 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 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 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?
Number of Adverse Events (time frame: 2 years). 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 6 Apr 2020.