Cervical AdenocarcinomaPhase 1NCT00054444
Radiation Therapy and Chemotherapy in Treating Patients With Locally Advanced Cervical Cancer
A Phase 1 study testing Topotecan Hydrochloride Liposomes, 3-Dimensional Conformal Radiation Therapy and Cisplatin in people with Cervical Adenocarcinoma and Cervical Squamous Cell Carcinoma, run by Gynecologic Oncology Group at 10 sites in United States.
Trial summary
This phase I trial is studying the side effects and best way to give radiation therapy when given together with topotecan and cisplatin in treating patients with locally advanced cervical cancer. This trial is also studying the best dose of topotecan when given in this regimen. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Cervical Adenocarcinoma, Cervical Squamous Cell Carcinoma, Stage IB Cervical Cancer
- What is being tested?
- Topotecan Hydrochloride Liposomes, 3-Dimensional Conformal Radiation Therapy and Cisplatin
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11 participants
- Where
- 10 sitesUnited States
- Study dates
- Sep 2007to Jan 2012
- 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 Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Histologically confirmed primary invasive carcinoma of the uterine cervix
- Stages IB2, II, IIIB, and IVA disease
- Any cell type
- No known metastasis to scalene nodes or organs outside the radiation field
- No known intraperitoneal metastases
- No evidence of extrapelvic disease based on negative CT or PET scan
Show all 28Show fewer
- Must enroll within 8 weeks of diagnosis
- Performance status - GOG 0-2
- Absolute neutrophil count ≥ 1,500/mm^3
- Platelet count ≥ 100,000/mm^3
- Bilirubin ≤ 1.5 times upper limit of normal (ULN)
- SGOT ≤ 2.5 times ULN
- Alkaline phosphatase ≤ 2.5 times ULN
- Creatinine normal
- Creatinine clearance > 50 mL/min
- Prior ureteral obstruction allowed provided stent or nephrostomy tube has been placed
- No renal abnormalities, such as pelvic kidney, horseshoe kidney, or prior renal transplantation that would require modification of radiation fields
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- No other malignancy within the past 5 years except nonmelanoma skin cancer
- No septicemia or severe infection
- No other medical or psychiatric condition that would preclude study compliance
- No prior chemotherapy for any prior malignancy
- No prior cytotoxic chemotherapy for this malignancy
- No prior radiotherapy for any prior malignancy
- No prior pelvic or abdominal radiotherapy for this malignancy
- No prior therapy for this malignancy
Who cannot join
None listed.
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
United States10 sites
Cooper Hospital University Medical Center
Camden, New Jersey, 08103
University of Chicago Comprehensive Cancer Center
Chicago, Illinois, 60637
MetroHealth Medical Center
Cleveland, Ohio, 44109
University of Missouri - Ellis Fischel
Columbia, Missouri, 65212
Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical Center
Columbus, Ohio, 43210
Riverside Methodist Hospital
Columbus, Ohio, 43214
University of Iowa Hospitals and Clinics
Iowa City, Iowa, 52242
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, 73104
Cancer Care Associates-Midtown
Tulsa, Oklahoma, 74104
Tulsa Cancer Institute
Tulsa, Oklahoma, 74146
About this study
Official title: A PHASE I STUDY OF PELVIC RADIATION THERAPY WITH CONCOMITANT WEEKLY CISPLATIN AND TOPOTECAN CHEMOTHERAPY IN PATIENTS WITH CERVICAL CARCINOMA WITHOUT EXTRA-PELVIC METASTASIS
This phase I trial is studying the side effects and best way to give radiation therapy when given together with topotecan and cisplatin in treating patients with locally advanced cervical cancer. This trial is also studying the best dose of topotecan when given in this regimen. Radiation therapy uses high-energy x-rays to damage tumor cells. Drugs used in chemotherapy, such as topotecan and cisplatin, use different ways to stop tumor cells from dividing so they stop growing or die. Combining radiation therapy with chemotherapy may kill more tumor cells.
Read the detailed description
PRIMARY OBJECTIVES:
- Determine the safety and tolerability of pelvic radiotherapy, cisplatin, and topotecan in patients with locally advanced cervical cancer.
II. Determine the maximum tolerated dose (MTD) of topotecan when administered in this regimen in this patient population.
SECONDARY OBJECTIVES:
- Determine the site of recurrence (local vs distant) in patients treated with this regimen.
OUTLINE: This is a multicenter, dose-escalation study of topotecan.
Patients undergo radiotherapy 5 days a week for 6 weeks. Patients receive cisplatin IV and topotecan IV over 30 minutes once weekly for a total of 6 weeks in the absence of disease progression or unacceptable toxicity.
Cohorts of 3-6 patients receive escalating doses of topotecan until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose at which 1 of 6 patients experiences dose-limiting toxicity. Once the MTD is determined, an additional cohort of 20 patients receives treatment as above at the MTD.
After completion of study treatment, patients are followed periodically for 5 years.
- Conditions
- Cervical Adenocarcinoma, Cervical Squamous Cell Carcinoma, Stage IB Cervical Cancer, Stage IIA Cervical Cancer, Stage IIB Cervical Cancer, Stage III Cervical Cancer
- Being tested
- Topotecan Hydrochloride Liposomes, 3-Dimensional Conformal Radiation Therapy, Cisplatin
- 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.
Topotecan Hydrochloride LiposomesDrug
Also called Brakiva
Given IV
3-Dimensional Conformal Radiation TherapyRadiation
Also called 3D-CRT, Conformal Therapy, Radiation Conformal Therapy
CisplatinDrug
Given IV
| Study group | Role | What they receive |
|---|---|---|
| Treatment (topotecan hydrochloride, radiation, cisplatin) | Experimental | Patients undergo radiotherapy 5 days a week for 6 weeks. Patients receive cisplatin IV and topotecan IV over 30 minutes once weekly for a total of 6 weeks in the absence of disease progression or unacceptable toxicity. Receives: Drug: Topotecan Hydrochloride Liposomes; Radiation: 3-Dimensional Conformal Radiation Therapy; Drug: Cisplatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of patients with acute toxicity assessed by Common Terminology Criteria for Adverse Events version 3.0
Measured: Up to 30 days after completion of radiation therapy
Incidence of patients with chronic toxicity assessed by Common Toxicity Criteria Radiation Therapy Oncology Group/European Organisation for Research and Treatment of Cancer (CTC RTOG/EORTC)
Measured: Up to 5 years
Secondary outcomes (1)
Site of treatment failure
Identified as local versus distant.
Measured: Up to 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2003 (estimated)
- Study startSep 2007
- Primary completionJan 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cervical AdenocarcinomaStudies 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 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gynecologic Oncology Group
- Sponsor type
- Research network
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Peter Rose, Principal investigator, Gynecologic Oncology Group
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00054444
- Sponsor's protocol ID
- GOG-9913
- Other IDs
- NCI-2009-00617, CDR0000270680, GOG-9913, GOG-9913, GOG-9913, U10CA027469
- Status last verified
- Dec 2014
- First submitted
- 5 Feb 2003
- Last updated
- 31 Dec 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A PHASE I STUDY OF PELVIC RADIATION THERAPY WITH CONCOMITANT WEEKLY CISPLATIN AND TOPOTECAN CHEMOTHERAPY IN PATIENTS WITH CERVICAL CARCINOMA WITHOUT EXTRA-PELVIC METASTASIS
- ClinicalTrials.gov ID
- NCT00054444
- Acronym / sponsor ID
- GOG-9913
- Conditions
- Cervical Adenocarcinoma, Cervical Squamous Cell Carcinoma, Stage IB Cervical Cancer, Stage IIA Cervical Cancer, Stage IIB Cervical Cancer, Stage III Cervical Cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 11 participants (actual)
- Lead sponsor
- Gynecologic Oncology GroupResearch network
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Sep 2007
- Primary completion
- Jan 2012 (actual)
- First posted
- 6 Feb 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.
This phase I trial is studying the side effects and best way to give radiation therapy when given together with topotecan and cisplatin in treating patients with locally advanced cervical cancer. This trial is also studying the best dose of topotecan when given in this regimen. Radiation therapy uses high-energy x-rays to damage tumor cells. Drugs used in chemotherapy, such as topotecan and cisplatin, use different ways to stop tumor cells from dividing so they stop growing or die. Combining radiation therapy with chemotherapy may kill more tumor cells.
Detailed description
PRIMARY OBJECTIVES:
- Determine the safety and tolerability of pelvic radiotherapy, cisplatin, and topotecan in patients with locally advanced cervical cancer.
II. Determine the maximum tolerated dose (MTD) of topotecan when administered in this regimen in this patient population.
SECONDARY OBJECTIVES:
- Determine the site of recurrence (local vs distant) in patients treated with this regimen.
OUTLINE: This is a multicenter, dose-escalation study of topotecan.
Patients undergo radiotherapy 5 days a week for 6 weeks. Patients receive cisplatin IV and topotecan IV over 30 minutes once weekly for a total of 6 weeks in the absence of disease progression or unacceptable toxicity.
Cohorts of 3-6 patients receive escalating doses of topotecan until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose at which 1 of 6 patients experiences dose-limiting toxicity. Once the MTD is determined, an additional cohort of 20 patients receives treatment as above at the MTD.
After completion of study treatment, patients are followed periodically for 5 years.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment (topotecan hydrochloride, radiation, cisplatin) | Experimental | Drug: Topotecan Hydrochloride Liposomes, Radiation: 3-Dimensional Conformal Radiation Therapy, Drug: CisplatinPatients undergo radiotherapy 5 days a week for 6 weeks. Patients receive cisplatin IV and topotecan IV over 30 minutes once weekly for a total of 6 weeks in the absence of disease progression or unacceptable toxicity. |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (28 listed)
- Histologically confirmed primary invasive carcinoma of the uterine cervix
- No known metastasis to scalene nodes or organs outside the radiation field
- No known intraperitoneal metastases
- No evidence of extrapelvic disease based on negative CT or PET scan
- Must enroll within 8 weeks of diagnosis
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Topotecan Hydrochloride LiposomesAlso: BrakivaGiven IV | Drug | Treatment (topotecan hydrochloride, radiation, cisplatin) |
| 3-Dimensional Conformal Radiation TherapyAlso: 3D-CRT, Conformal Therapy, Radiation Conformal Therapy | Radiation | Treatment (topotecan hydrochloride, radiation, cisplatin) |
| CisplatinGiven IV | Drug | Treatment (topotecan hydrochloride, radiation, cisplatin) |
Primary outcome
Incidence of patients with acute toxicity assessed by Common Terminology Criteria for Adverse Events version 3.0
Time frame: Up to 30 days after completion of radiation therapy
Incidence of patients with chronic toxicity assessed by Common Toxicity Criteria Radiation Therapy Oncology Group/European Organisation for Research and Treatment of Cancer (CTC RTOG/EORTC)
Time frame: Up to 5 years
1 secondary outcome
Site of treatment failure
Time frame: Up to 5 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 31 Dec 2014.
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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.
Peter Rose principal investigator
Gynecologic Oncology Group
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Topotecan Hydrochloride Liposomes, 3-Dimensional Conformal Radiation Therapy and Cisplatin in people with Cervical Adenocarcinoma and Cervical Squamous Cell Carcinoma, run by Gynecologic Oncology Group at 10 sites 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 28 inclusion and 0 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 31 Dec 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites 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?
Incidence of patients with acute toxicity assessed by Common Terminology Criteria for Adverse Events version 3.0 (time frame: Up to 30 days after completion of radiation therapy). The study lists 2 primary outcomes in all. 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 31 Dec 2014.