Unspecified Adult Solid Tumor, Protocol SpecificPhase 2NCT00274859
Gemcitabine and Oxaliplatin in Treating Patients With Metastatic Cancer
A Phase 2 study testing gemcitabine hydrochloride and oxaliplatin in people with Unspecified Adult Solid Tumor, Protocol Specific, run by GERCOR - Multidisciplinary Oncology Cooperative Group at 14 sites in France.
Trial summary
RATIONALE: Drugs used in chemotherapy, such as gemcitabine and oxaliplatin, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more cancer cells. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Unspecified Adult Solid Tumor, Protocol Specific
- What is being tested?
- gemcitabine hydrochloride and oxaliplatin
- How many people
- 45 participants
- Where
- 14 sitesFrance
- Study dates
- Aug 2005to not given
- Phase
- Phase 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
- All sexes
- No healthy volunteers
- Adult, Older adult
DISEASE CHARACTERISTICS:
- Histologically confirmed cancer
- Metastatic disease
- Measurable metastatic disease ≥ 1 cm by spiral CT scan and/or cutaneous lesion ≥ 2 cm
- Not a candidate for anthracycline or taxane chemotherapy
- No brain metastases
PATIENT CHARACTERISTICS:
- ECOG performance status (PS) 0-2 OR Karnofsky PS 60-100%
- Life expectancy > 12 weeks
- Neutrophil count > 1,000/mm^3
- Platelet count > 100,000/mm^3
- Alkaline phosphatase < 5 times upper limit of normal (ULN)
- Bilirubin < 1.5 times ULN
- Creatinine < 1.5 times ULN OR creatinine clearance > 30 mL/min
- SGOT and SGPT < 3 times ULN (5 times ULN if liver metastases present)
- No pre-existing neuropathy
- Not pregnant or nursing
- No uncontrolled hypercalcemia
- No familial, social, geographical, or psychological condition that would preclude study treatment
- No other malignancy that is not considered cured
PRIOR CONCURRENT THERAPY:
- No prior chemotherapy for metastatic disease, including anthracyclines or taxanes
- Prior hormonal therapy allowed
Trial locations and contacts
14 sites in 1 country.
14 sites in 1 country
France14 sites
C.H.G. Beauvais
Beauvais, 60021
Centre Hospitalier Regional de Besancon - Hopital Jean Minjoz
Besançon, 25030
Centre Hospitalier Docteur Duchenne
Boulogne-sur-Mer, 62200
Centre Jean Perrin
Clermont-Ferrand, 63011
Intercommunal Hospital
Montfermeil, 93370
Hopital Saint Antoine
Paris, 75571
Hopital Tenon
Paris, 75970
Polyclinique De Courlancy
Reims, F-51100
Centre Rene Huguenin
Saint-Cloud, 92210
Centre Hospitalier de Saint-Quentin
Saint-Quentin, 02321
C.H. Senlis
Senlis, 60309
Centre Paul Strauss
Strasbourg, 67065
Centre Hospitalier Intercommunal Toulon - La Seyne Sur Mer
Toulon, 83056
Institut Gustave Roussy
Villejuif, F-94805
About this study
Official title: Multicenter Phase II Study Evaluating Gemcitabine and Oxaliplatin in the Treatment of Patients Suffering From Metastatic Breast Cancer Who Are Not Candidates For Treatment With Antracyclines and Taxanes
RATIONALE: Drugs used in chemotherapy, such as gemcitabine and oxaliplatin, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more cancer cells.
PURPOSE: This phase II trial is studying how well giving gemcitabine together with oxaliplatin works in treating patients with metastatic cancer who cannot receive anthracycline or taxane therapy.
Read the detailed description
OBJECTIVES:
Primary
- Determine the objective response rate in patients with metastatic cancer not amenable to anthracycline or taxane therapy treated with gemcitabine hydrochloride and oxaliplatin.
Secondary
- Determine the clinical benefit and tolerability of this regimen in these patients.
- Determine the progression-free and overall survival of patients treated with this regimen.
OUTLINE: This is an open-label, multicenter study.
Patients receive gemcitabine hydrochloride IV over 100 minutes on day 1 and oxaliplatin IV over 2 hours on day 2. Treatment repeats every 2 weeks in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed periodically.
PROJECTED ACCRUAL: A total of 45 patients will be accrued for this study.
- Being tested
- gemcitabine hydrochloride, oxaliplatin
- Keywords
- unspecified adult solid tumor, protocol specific
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective response rate
Secondary outcomes (4)
Clinical benefit
Tolerability
Progression-free
Overall survival
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2006 (estimated)
- Study startAug 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Unspecified Adult Solid Tumor, Protocol SpecificStudies 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 2
- Primary purpose
- Treatment
- Masking
- None (open label)
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- GERCOR - Multidisciplinary Oncology Cooperative Group
- Sponsor type
- University, hospital or other
- Investigators
- Joseph Gligorov, MD, Study chair, Hopital Tenon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00274859
- Sponsor's protocol ID
- CDR0000454320
- Other IDs
- GERCOR-SEGEMOX-S04-1, LILLY-GERCOR-SEGEMOX-S04-1, SANOFI-GERCOR-SEGEMOX-S04-1, EU-20571
- Status last verified
- May 2007
- First submitted
- 10 Jan 2006
- Last updated
- 24 Jul 2008
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter Phase II Study Evaluating Gemcitabine and Oxaliplatin in the Treatment of Patients Suffering From Metastatic Breast Cancer Who Are Not Candidates For Treatment With Antracyclines and Taxanes
- ClinicalTrials.gov ID
- NCT00274859
- Acronym / sponsor ID
- CDR0000454320
- Keywords
- unspecified adult solid tumor, protocol specific
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- GERCOR - Multidisciplinary Oncology Cooperative GroupUniversity, hospital or other
- Study start
- Aug 2005
- First posted
- 11 Jan 2006 (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 gemcitabine and oxaliplatin, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more cancer cells.
PURPOSE: This phase II trial is studying how well giving gemcitabine together with oxaliplatin works in treating patients with metastatic cancer who cannot receive anthracycline or taxane therapy.
Detailed description
OBJECTIVES:
Primary
- Determine the objective response rate in patients with metastatic cancer not amenable to anthracycline or taxane therapy treated with gemcitabine hydrochloride and oxaliplatin.
Secondary
- Determine the clinical benefit and tolerability of this regimen in these patients.
- Determine the progression-free and overall survival of patients treated with this regimen.
OUTLINE: This is an open-label, multicenter study.
Patients receive gemcitabine hydrochloride IV over 100 minutes on day 1 and oxaliplatin IV over 2 hours on day 2. Treatment repeats every 2 weeks in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed periodically.
PROJECTED ACCRUAL: A total of 45 patients will be accrued for this study.
Study design
- Primary purpose
- Treatment
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- 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 |
|---|---|---|
| gemcitabine hydrochloride | Drug | – |
| oxaliplatin | Drug | – |
Primary outcome
Objective response rate
4 secondary outcomes
Clinical benefit
Tolerability
Progression-free
Overall survival
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2008.
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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.
Joseph Gligorov, MD study chair
Hopital Tenon
14 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing gemcitabine hydrochloride and oxaliplatin in people with Unspecified Adult Solid Tumor, Protocol Specific, run by GERCOR - Multidisciplinary Oncology Cooperative Group at 14 sites 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: status not confirmed, as of the sponsor's last update on 24 Jul 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 sites 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 phase mean?
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?
Results are not available in the source record.
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?
Objective response rate. 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 24 Jul 2008.