Cervical CarcinomaPhase 1NCT01554410
Intensity Modulated Radiation Therapy With Cisplatin and Gemcitabine to Treat Locally Advanced Cervical Carcinoma
A Phase 1 study testing Intensity Modulated Radiation Therapy (IMRT), Cisplatin and Gemcitabine in people with Cervical Carcinoma, run by University of California, San Diego at 1 site in United States.
Trial summary
The primary objective of the study is to identify the highest dose of gemcitabine that can be given safely with cisplatin and pelvic intensity modulated radiation therapy (IMRT) in women with locally advanced cervical cancer. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Cervical Carcinoma
- What is being tested?
- Intensity Modulated Radiation Therapy (IMRT), Cisplatin and Gemcitabine
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2010to 1 Aug 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
- Diagnosis: Histologically-proven, invasive primary carcinoma of the cervix.
- Disease Status: Stage IB2-IVA cervical cancer or stage I with biopsy-proven pelvic node metastases, positive surgical margins, or parametrial extension based upon standard diagnostic workup, including:
- History/physical examination
- Examination under anesthesia (if indicated)
- Biopsy
- Intravenous pyelogram and/or cystoscopy (if indicated)
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- Colonoscopy, sigmoidoscopy, or rigid proctoscopy (if indicated)
- PA and lateral chest x-ray or chest CT
- CT or MRI of the pelvis
- PET, PET/CT, or PET/CT simulation (encouraged)
- Performance Level: Karnofsky Performance Status ≥ 60 - Peripheral ≥ ANC 1500/uL
- Platelet count ≥ 100,000/uL (transfusion independent)
- Hemoglobin ≥ 8.0 g/dL (Note: The use of transfusion or other intervention to achieve Hgb ≥ 8.0 g/dL is acceptable)
- Serum creatinine ≤ 1.5 mg/dl
- Bilirubin (sum of conjugated + unconjugated) < 1.5 mg/dl, and
- SGPT (ALT) < 1.5 x upper limit of normal (ULN) for age, and
- SGOT (AST) < 1.5 x upper limit of normal (ULN) for age
Who cannot join
- Pregnancy or Breast-Feeding: Pregnant or breast-feeding women will not be entered on this study due to risks of fetal and teratogenic adverse events.(Note: Serum Pregnancy tests must be obtained in women of child bearing potential). Sexually active females may not participate unless they have agreed to use an effective contraceptive method (such as abstinence, diaphragm, condom, or intrauterine device) to prevent pregnancy for the duration of the study.
- Concomitant Medications, if taken within the last 28 days.
- Growth factor(s): Growth factors that support platelet or white cell number or function must not have been administered within the past 28 days.
- Erythropoietic drug(s): Erythropoietin or related hormones must not have been administered within the past 28 days.
- Infection: Patients who have an uncontrolled infection.
- Evidence of para-aortic lymphadenopathy or distant metastases
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- Prior invasive malignancy (except non-melanomatous skin cancer), unless disease free for a minimum of 3 years.
- Prior systemic chemotherapy within the last three years.
- Prior radiotherapy to the pelvis
- Allergic to iodinated contrast if undergoing a contrast enhanced CT scan of the pelvis
Trial locations and contacts
1 site in 1 country.
United States1 site
Moores UC San Diego Cancer Center
La Jolla, California, 92093
About this study
Official title: A Phase I Trial of Intensity Modulated Radiation Therapy With Concurrent Cisplatin and Escalating Gemcitabine for Locally Advanced Cervical Carcinoma
The primary objective of the study is to identify the highest dose of gemcitabine that can be given safely with cisplatin and pelvic intensity modulated radiation therapy (IMRT) in women with locally advanced cervical cancer. The investigators hypothesis is that IMRT will reduce gastrointestinal and hematologic toxicity, permitting escalating doses of gemcitabine to be feasibly delivered in patients with locally advanced cervical cancer.
Read the detailed description
Many studies have investigated multiagent chemotherapy as a means of intensifying treatment. The results of such trials indicate that gemcitabine has considerable activity against cervical cancer when given with cisplatin/RT, however, it is quite toxic. The predominant toxicities are gastrointestinal and hematologic. Methods to reduce gastrointestinal and hematologic toxicity during chemoradiotherapy could mitigate this toxicity and take advantage of the therapeutic benefits of gemcitabine
IMRT is an advanced radiation therapy delivery technique that reduces the amount of radiation given to normal tissues and may therefore reduce unwanted side effects. IMRT tries to lower the amount of radiation that normal tissues receive, while still delivering the desired amount of radiation to the cancer cells and other areas, such as lymph nodes. IMRT does this by using computers to design the best way to aim radiation at the tumor(s), while still delivering a radiation dose comparable to standard radiation.
- Conditions
- Cervical Carcinoma
- Being tested
- Intensity Modulated Radiation Therapy (IMRT), Cisplatin, Gemcitabine
- Keywords
- Cervical, Carcinoma, Gemcitabine, Gemzar, Cisplatin, IMRT, Radiation, External Beam, Brachytherapy
- Medical subject headings
- Uterine Cervical Neoplasms, Carcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intensity Modulated Radiation Therapy (IMRT)Radiation
45 Gy in 25 daily fractions (1.8 Gy per fraction)
CisplatinDrug
Weekly infusion of 40 mg/m2 x 5 weeks (70 mg maximum)
GemcitabineDrug
Weekly infusion x 5 weeks at escalating dose levels (50mg/m2, 75mg/m2, 100mg/m2, and 125mg/m2)
| Study group | Role | What they receive |
|---|---|---|
| IMRT/Cisplatin/Gemcitabine | Experimental | All patients get IMRT with concurrent cisplatin \& gemcitabine, with the dose of gemcitabine varying according to cohort Receives: Radiation: Intensity Modulated Radiation Therapy (IMRT); Drug: Cisplatin; Drug: Gemcitabine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Establish the maximum tolerated dose (MTD) of Gemcitabine that can be safely administered in combination with Cisplatin
To determine the maximum tolerated dose (MTD) of weekly gemcitabine that can be administered with concurrent weekly cisplatin and pelvic intensity modulated radiation therapy (IMRT) in women with locally advanced cervical cancer
Measured: 5 weeks during treatment
Secondary outcomes (2)
Number of Participants with Acute Adverse Events as a Measure of Safety and Tolerability
To quantify acute treatment-related adverse events that occur within 30 days of completing protocol treatment.
Measured: Up to 30 Days post-treatment
Number of Participants with Progression-Free Survival as a Measure of Response
To determine the progression-free and overall survival of patients treated with gemcitabine at the MTD in this regimen.
Measured: Up to 12 months post treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2012 (estimated)
- Study startAug 2010
- Primary completion16 Jul 2019
- Study completion1 Aug 2020
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 Cervical CarcinomaStudies of the same condition, open and under way.
- More trials run by University of California, San DiegoThe 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
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Diego
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Loren Mell, MD, University of California, San Diego
- Investigators
- Loren Mell, MD, Principal investigator, University of California, San Diego
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01554410
- Sponsor's protocol ID
- UCSD 100597
- Status last verified
- Feb 2022
- First submitted
- 8 Mar 2012
- Last updated
- 17 Feb 2022
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Mell LK, Xu R, Yashar CM, McHale MT, Einck JP, Mayadev J, Lee E, Binder P, Rash D, Eskander R, Heide ES, Plaxe SC, Mundt AJ, Saenz CC. Phase 1 Trial of Concurrent Gemcitabine and Cisplatin with Image Guided Intensity Modulated Radiation Therapy for Locoregionally Advanced Cervical Carcinoma. Int J Radiat Oncol Biol Phys. 2020 Aug 1;107(5):964-973. doi: 10.1016/j.ijrobp.2020.04.019. Epub 2020 Apr 22.
PubMed 32334034
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Trial of Intensity Modulated Radiation Therapy With Concurrent Cisplatin and Escalating Gemcitabine for Locally Advanced Cervical Carcinoma
- ClinicalTrials.gov ID
- NCT01554410
- Acronym / sponsor ID
- UCSD 100597
- Conditions
- Cervical Carcinoma
- Keywords
- Cervical, Carcinoma, Gemcitabine, Gemzar, Cisplatin, IMRT, Radiation, External Beam
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- University of California, San DiegoUniversity, hospital or other
- Study start
- Aug 2010
- Primary completion
- 16 Jul 2019 (actual)
- Study completion
- 1 Aug 2020 (actual)
- First posted
- 15 Mar 2012 (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.
The primary objective of the study is to identify the highest dose of gemcitabine that can be given safely with cisplatin and pelvic intensity modulated radiation therapy (IMRT) in women with locally advanced cervical cancer. The investigators hypothesis is that IMRT will reduce gastrointestinal and hematologic toxicity, permitting escalating doses of gemcitabine to be feasibly delivered in patients with locally advanced cervical cancer.
Detailed description
Many studies have investigated multiagent chemotherapy as a means of intensifying treatment. The results of such trials indicate that gemcitabine has considerable activity against cervical cancer when given with cisplatin/RT, however, it is quite toxic. The predominant toxicities are gastrointestinal and hematologic. Methods to reduce gastrointestinal and hematologic toxicity during chemoradiotherapy could mitigate this toxicity and take advantage of the therapeutic benefits of gemcitabine
IMRT is an advanced radiation therapy delivery technique that reduces the amount of radiation given to normal tissues and may therefore reduce unwanted side effects. IMRT tries to lower the amount of radiation that normal tissues receive, while still delivering the desired amount of radiation to the cancer cells and other areas, such as lymph nodes. IMRT does this by using computers to design the best way to aim radiation at the tumor(s), while still delivering a radiation dose comparable to standard radiation.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| IMRT/Cisplatin/Gemcitabine | Experimental | Radiation: Intensity Modulated Radiation Therapy (IMRT), Drug: Cisplatin, Drug: GemcitabineAll patients get IMRT with concurrent cisplatin \& gemcitabine, with the dose of gemcitabine varying according to cohort |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- Diagnosis: Histologically-proven, invasive primary carcinoma of the cervix.
- Disease Status: Stage IB2-IVA cervical cancer or stage I with biopsy-proven pelvic node metastases, positive surgical margins, or parametrial extension based upon standard diagnostic workup, including:
- History/physical examination
- Examination under anesthesia (if indicated)
- Biopsy
Key exclusion criteria (10 listed)
- Pregnancy or Breast-Feeding: Pregnant or breast-feeding women will not be entered on this study due to risks of fetal and teratogenic adverse events.(Note: Serum Pregnancy tests must be obtained in women of child bearing potential). Sexually active females may not participate unless they have agreed to use an effective contraceptive method (such as abstinence, diaphragm, condom, or intrauterine device) to prevent pregnancy for the duration of the study.
- Concomitant Medications, if taken within the last 28 days.
- Growth factor(s): Growth factors that support platelet or white cell number or function must not have been administered within the past 28 days.
- Erythropoietic drug(s): Erythropoietin or related hormones must not have been administered within the past 28 days.
- Infection: Patients who have an uncontrolled infection.
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 |
|---|---|---|
| Intensity Modulated Radiation Therapy (IMRT)45 Gy in 25 daily fractions (1.8 Gy per fraction) | Radiation | IMRT/Cisplatin/Gemcitabine |
| CisplatinWeekly infusion of 40 mg/m2 x 5 weeks (70 mg maximum) | Drug | IMRT/Cisplatin/Gemcitabine |
| GemcitabineWeekly infusion x 5 weeks at escalating dose levels (50mg/m2, 75mg/m2, 100mg/m2, and 125mg/m2) | Drug | IMRT/Cisplatin/Gemcitabine |
Primary outcome
Establish the maximum tolerated dose (MTD) of Gemcitabine that can be safely administered in combination with Cisplatin
Time frame: 5 weeks during treatment
To determine the maximum tolerated dose (MTD) of weekly gemcitabine that can be administered with concurrent weekly cisplatin and pelvic intensity modulated radiation therapy (IMRT) in women with locally advanced cervical cancer
2 secondary outcomes
Number of Participants with Acute Adverse Events as a Measure of Safety and Tolerability
Time frame: Up to 30 Days post-treatment
Number of Participants with Progression-Free Survival as a Measure of Response
Time frame: Up to 12 months post treatment
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 17 Feb 2022.
- Derived from this study: PubMed 32334034Mell LK, Xu R, Yashar CM, McHale MT, Einck JP, Mayadev J, Lee E, Binder P, Rash D, Eskander R, Heide ES, Plaxe SC, Mundt AJ, Saenz CC. Phase 1 Trial of Concurrent Gemcitabine and Cisplatin with Image Guided Intensity Modulated Radiation Therapy for Locoregionally Advanced Cervical Carcinoma. Int J Radiat Oncol Biol Phys. 2020 Aug 1;107(5):964-973. doi: 10.1016/j.ijrobp.2020.04.019. Epub 2020 Apr 22.
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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.
Loren Mell, MD principal investigator
University of California, San Diego
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 Intensity Modulated Radiation Therapy (IMRT), Cisplatin and Gemcitabine in people with Cervical Carcinoma, run by University of California, San Diego 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 17 inclusion and 10 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 17 Feb 2022. 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?
Establish the maximum tolerated dose (MTD) of Gemcitabine that can be safely administered in combination with Cisplatin (time frame: 5 weeks during treatment). 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 NCT01554410, 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 17 Feb 2022.