Cervical CancerPhase 1/2NCT00807079
Carboplatin and Topotecan in Treating Patients With Relapsed or Metastatic Cervical Cancer
A Phase 1/2 study testing carboplatin and topotecan hydrochloride in people with Cervical Cancer, run by ARCAGY/ GINECO GROUP at 1 site in France.
Trial summary
RATIONALE: Drugs used in chemotherapy, such as carboplatin and topotecan, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells. 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?
- carboplatin and topotecan hydrochloride
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteFrance
- Study dates
- Sep 2008to May 2011
- Phase
- Phase 1/2
- 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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
DISEASE CHARACTERISTICS:
- Histologically confirmed cervical cancer, including the following cell types:
- Squamous cell carcinoma
- Adenocarcinoma
- Adenosquamous cell carcinoma
- Metastatic disease or in first relapse
- Not curable by surgery and/or radiotherapy with or without chemotherapy
- At least 1 non-irradiated measurable lesion
- No CNS metastases
PATIENT CHARACTERISTICS:
- WHO performance status 0-2
- ANC ≥ 1,500/mm^3
- Platelet count ≥ 100,000/mm^3
- Transaminases ≤ 3 times upper limit of normal (ULN) (≤ 5 times ULN in the presence of liver metastases)
- Total bilirubin ≤ 1.5 times ULN
- Creatinine clearance ≥ 50 mL/min
- Not pregnant or nursing
- Fertile patients must use effective contraception
- No other cancer within the past 5 years except for adequately treated basal cell or squamous cell carcinoma of the skin
- No swallowing disorders or gastrointestinal disease resulting in an inability to take oral medication or a requirement for IV alimentation
- No altered intestinal absorption
- No peptic ulcers
- No nephrostomy
- Double-J catheter allowed
- None of the following cardiovascular conditions within the past 6 months:
- Uncontrolled hypertension
- Coronary artery disease
- NYHA class III or IV congestive heart failure
- Ventricular arrhythmia
- Unstable angina
- Myocardial infarction
- No infection or serious illness that would preclude study treatment
- No contraindications to study treatment
- No psychological, familial, sociological, or geographical condition that would preclude follow-up
PRIOR CONCURRENT THERAPY:
- No prior cytotoxic therapy except for chemoradiotherapy or pelvic radiotherapy
- At least 6 months since prior platinum-based chemoradiotherapy
- No concurrent participation in another clinical trial that could interfere with the objectives of this study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase I/II Study of Carboplatin in Association With Weekly Oral Topotecan in Patients With Metastatic or Recurrent Cervical Cancer
RATIONALE: Drugs used in chemotherapy, such as carboplatin and topotecan, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells.
PURPOSE: This phase I/II trial is studying the side effects and best dose of topotecan when given together with carboplatin and to see how well they work in treating patients with relapsed or metastatic cervical cancer.
Read the detailed description
OBJECTIVES:
Primary
- To determine the maximum tolerated dose of topotecan hydrochloride when administered with carboplatin in patients with relapsed or metastatic cervical cancer. (Phase I)
- To determine the objective response rate in patients treated with this regimen. (Phase II)
Secondary
- To determine the dose-limiting toxicities of this regimen in these patients. (Phase I)
- To assess the progression-free survival of patients treated with this regimen. (Phase II)
- To assess the overall survival of patients treated with this regimen. (Phase II)
- To assess the tolerability of this regimen in these patients. (Phase II)
OUTLINE: This is a multicenter, phase I dose-escalation study of topotecan hydrochloride followed by a phase II study.
Patients receive oral topotecan hydrochloride on days 1, 8, and 15 and carboplatin IV on day 1. Treatment repeats every 4 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity.
Patients complete a quality-of-life questionnaire at baseline and then every 3 months thereafter.
After completion of study therapy, patients are followed every 3 months for 1 year.
- Conditions
- Cervical Cancer
- Being tested
- carboplatin, topotecan hydrochloride
- Keywords
- recurrent cervical cancer, stage IVB cervical cancer, stage IVA cervical cancer, cervical adenocarcinoma, cervical adenosquamous cell carcinoma, 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.
carboplatinDrug
topotecan hydrochlorideDrug
| Study group | Role | What they receive |
|---|---|---|
| single arm | Experimental | Not described Receives: Drug: carboplatin; Drug: topotecan hydrochloride |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum tolerated dose of topotecan hydrochloride (Phase I)
Measured: 3 months
Objective response rate (Phase II)
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2008 (estimated)
- Study startSep 2008
- Primary completionMay 2011
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.
- 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 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- ARCAGY/ GINECO GROUP
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Laure Chauvenet, MD, Principal investigator, Hotel Dieu de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00807079
- Sponsor's protocol ID
- CDR0000626790
- Other IDs
- ARCAGY-GINECO-CE102, ARCAGY-HYCAR, INCA-RECF0757, EUDRACT-2008-001842-19
- Status last verified
- Oct 2014
- First submitted
- 10 Dec 2008
- Last updated
- 29 Oct 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I/II Study of Carboplatin in Association With Weekly Oral Topotecan in Patients With Metastatic or Recurrent Cervical Cancer
- ClinicalTrials.gov ID
- NCT00807079
- Acronym / sponsor ID
- CDR0000626790
- Conditions
- Cervical Cancer
- Keywords
- recurrent cervical cancer, stage IVB cervical cancer, stage IVA cervical cancer, cervical adenocarcinoma, cervical adenosquamous cell carcinoma, cervical squamous cell carcinoma
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- ARCAGY/ GINECO GROUPUniversity, hospital or other
- Study start
- Sep 2008
- Primary completion
- May 2011 (actual)
- First posted
- 11 Dec 2008 (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: Drugs used in chemotherapy, such as carboplatin and topotecan, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells.
PURPOSE: This phase I/II trial is studying the side effects and best dose of topotecan when given together with carboplatin and to see how well they work in treating patients with relapsed or metastatic cervical cancer.
Detailed description
OBJECTIVES:
Primary
- To determine the maximum tolerated dose of topotecan hydrochloride when administered with carboplatin in patients with relapsed or metastatic cervical cancer. (Phase I)
- To determine the objective response rate in patients treated with this regimen. (Phase II)
Secondary
- To determine the dose-limiting toxicities of this regimen in these patients. (Phase I)
- To assess the progression-free survival of patients treated with this regimen. (Phase II)
- To assess the overall survival of patients treated with this regimen. (Phase II)
- To assess the tolerability of this regimen in these patients. (Phase II)
OUTLINE: This is a multicenter, phase I dose-escalation study of topotecan hydrochloride followed by a phase II study.
Patients receive oral topotecan hydrochloride on days 1, 8, and 15 and carboplatin IV on day 1. Treatment repeats every 4 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity.
Patients complete a quality-of-life questionnaire at baseline and then every 3 months thereafter.
After completion of study therapy, patients are followed every 3 months for 1 year.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| single arm | Experimental | Drug: carboplatin, Drug: topotecan hydrochloride |
Who may qualify
- Ages
- 18 years and older
- 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 | single arm |
| topotecan hydrochloride | Drug | single arm |
Primary outcome
Maximum tolerated dose of topotecan hydrochloride (Phase I)
Time frame: 3 months
Objective response rate (Phase II)
Time frame: 3 months
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 29 Oct 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.
Laure Chauvenet, MD principal investigator
Hotel Dieu de Paris
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing carboplatin and topotecan hydrochloride in people with Cervical Cancer, run by ARCAGY/ GINECO GROUP at 1 site in France.
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 29 Oct 2014. 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 France. 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 combined 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.
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.
What does the primary outcome measure?
Maximum tolerated dose of topotecan hydrochloride (Phase I) (time frame: 3 months). 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 29 Oct 2014.