Unknown Primary NeoplasmsPhase 2NCT00353145
Gemox as First and Second Line Therapy in Unknown Primary Cancer
A Phase 2 study testing Gemcitabine (Gemox), Oxaliplatin and Questionnaire in people with Unknown Primary Neoplasms, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial summary
Primary objectives: 1. To determine the overall tumor response rate with oxaliplatin in combination with gemcitabine (GEMOX) as first line and second line therapy in unknown primary cancer (UPC). 2. To determine the tolerability (toxicity) of this regimen in this patient population. Secondary objectives: 1. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Unknown Primary Neoplasms
- What is being tested?
- Gemcitabine (Gemox), Oxaliplatin and Questionnaire
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 29 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2004to Jan 2010
- 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
Who may be able to join
- Age >/= 18 years old.
- Signed informed consent/authorization is obtained prior to conducting any study-specific screening procedures.
- Patients should fulfill the criteria for UPC: no primary detected after a complete evaluation which is defined as complete history and physical, detailed laboratory examination, directed radiologic studies, symptom or sign directed invasive studies, directed immunohistochemistry studies and serum tumor markers.
- Previously untreated or has received no more than one prior chemotherapy regimen for unknown primary cancer. If the patients are previously treated, they may not have had previous exposure to gemcitabine or oxaliplatin. Prior exposure to cisplatin or carboplatin is allowed for this study.
- ECOG performance status must be 0-2 (Appendix A).
- Adequate hepatic, renal and bone marrow function: Leukocytes >= 3,000/uL; Absolute neutrophil count >= 1,500/uL; Platelets >= 100,000/uL; Total bilirubin <= 1.5 * institutional upper limits of normal (ULN); AST (SGOT)/ALT (SGPT) <= 2.5 * institutional ULN; Creatinine <= 1.5 mg/dL.
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- Women of childbearing potential are not excluded from this study; however all participants (men and women) with reproductive potential must practice an effective method of contraception while on this study in order to minimize risks to fetuses.
- Patients may have received prior radiation treatment but the last fraction of radiation treatment must have been completed at least 4 weeks prior to entry on this study.
- Patients must have at least one measurable lesion as per the RECIST Criteria that can be accurately measured in at least one dimension, with minimum lesion size equal to or more than twice the thickness of the imaging study used. If radiation was previously received, measurable disease must occur outside the previous radiation field, unless disease progression has been documented.
- Both men and women and members of all ethnic groups are eligible for this trial.
Who cannot join
- In previously treated patients; patients should not have received gemcitabine or oxaliplatin as one of the agents.
- Uncontrolled intercurrent illness including, but not limited to, active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmias not well controlled with medication, myocardial infarction within the previous 6 months, or psychiatric illness/social situations that would limit compliance with study requirements.
- Patients with known brain metastases should be excluded from this clinical trial because of their poor prognosis and because they often develop progressive neurological dysfunction that would confound the evaluation of neurological and other adverse events. A CT scan of the brain is not needed for eligibility and will be done only if the patient presents with symptoms suggestive of brain metastases.
- Patients who have had chemotherapy within 4 weeks (6 weeks for nitrosoureas or mitomycin C) prior to entering the study or those who have not recovered from adverse events due to agents administered more than 28 days earlier.
- Patients may not be receiving any other investigational agents, or have participated in any investigational drug study within 28 days preceding start of study treatment.
- The teratogenic potential of this combination is currently unknown. Women who are pregnant or lactating are excluded.
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- History of any other malignancy in the last 5 years, except patients with a prior history of in situ cancer or basal or squamous cell skin cancer are eligible.
- Peripheral neuropathy > grade 1.
- Female patients with adenocarcinoma with axillary only nodes will be excluded from the study.
Trial locations and contacts
1 site in 1 country.
United States1 site
U.T. M.D. Anderson Cancer Center
Houston, Texas, 77030
About this study
Official title: A Phase II Study to Evaluate the Efficacy and Toxicity of Oxaliplatin in Combination With Gemcitabine as First and Second Line Therapy in Unknown Primary Cancer
Primary objectives:
- To determine the overall tumor response rate with oxaliplatin in combination with gemcitabine (GEMOX) as first line and second line therapy in unknown primary cancer (UPC).
- To determine the tolerability (toxicity) of this regimen in this patient population.
Secondary objectives:
- To determine the median overall survival (OS) and time to progression (TTP) for patients treated with this combination.
- To determine the impact of this combination on quality of life (QOL) in this patient population.
Read the detailed description
Oxaliplatin is a chemotherapy drug that causes the death of cancer cells and other actively dividing cells by interfering with Deoxyribonucleic acid (DNA) function. Gemcitabine prevents cells from making DNA and Ribonucleic acid (RNA) that are necessary for cell growth, thus disrupting the growth of the cancer cells, which causes the cancer cells to start to die.
After the screening portion of the study, if you are eligible to begin study treatment, you will come to M. D. Anderson at least every two weeks (14 days) for treatment. Each 14-day period of treatment is called a "cycle" of therapy. You will receive at least 3 cycles of therapy (6 weeks) unless side effects become intolerable or the disease progresses.
When you begin treatment, you will have a small tube (central venous line) inserted into a large vein under the skin of the chest or through a vein in the arm for administration of oxaliplatin and gemcitabine. The central venous line will remain in place the entire time you are taking part in this study. Both drugs must be given at M. D. Anderson. On Day 1 of each cycle, you will receive gemcitabine injected into a vein over 2 hours. On Day 2 of each cycle you will receive oxaliplatin injected into a vein over 2 hours. This drug schedule will be repeated every 2 weeks.
You will first be asked to fill out several questionnaires that deal with your quality of life. These will help the researchers understand how the study drugs affect your quality of life including your pain level, fatigue (tiredness) level, appetite, and ability to perform everyday tasks, in spite of whether there is any shrinkage of the tumor. It will take about 30 minutes to an hour to complete the forms. You will also be asked to complete a questionnaire (one time only) that asks questions about why you decided to take part in this study.
During the first cycle of therapy, blood (about 2 1/2 teaspoons) will be collected once a week for routine tests. Before each new cycle of therapy, you will have a complete physical exam, urine will be collected, and blood will be drawn (about 2 ½ teaspoons) for routine tests. You will be asked to tell the study doctor about all medications you have taken since you started taking the study drugs and any health problems that you may have experienced. You will also have either computed tomography (CT) scans or an Magnetic resonance imaging (MRI) of the tumor(s) every 6 weeks and at the end of the study.
All tests before each new cycle of treatment and when treatment stops must be done at M. D. Anderson. Extra tests may be done during the study if your doctor feels it is necessary for your care. Every 6 weeks for as long as you are on study, you will also be asked to fill out the questionnaires that help study doctors understand your quality of life. It will take about 30 minutes to an hour to complete the forms.
If you experience intolerable side effects, treatment may be delayed, stopped, or you may receive smaller doses of the treatment. You may continue to receive treatment on this study, unless the disease gets worse or you experience any intolerable side effects. If this happens, you will be taken off the study and your doctor will discuss other treatment options with you.
When you stop taking part in the study for any reason, you will have blood (about 3 teaspoons) collected for final routine tests. You will have one more physical exam and either a CT scan or a MRI to check on the status of the disease. You will also be asked once more to fill out the questionnaires that help assess your quality of life. It will take about 30 minutes to an hour to complete the forms.
Once you stop receiving study treatment, you will be contacted by phone every three months for the rest of your life to check on how you are doing and any symptoms you may be experiencing.
This is an investigational study. Oxaliplatin is FDA approved for treatment of advanced cancer of the colon or rectum, and gemcitabine is FDA approved for the treatment of advanced cancer of the pancreas. However, the combination of the two drugs for treatment of cancers with unknown primaries is still considered investigational. Up to 81 people will take part in this study. All will be enrolled at M. D. Anderson.
- Conditions
- Unknown Primary Neoplasms
- Being tested
- Gemcitabine (Gemox), Oxaliplatin, Questionnaire
- Keywords
- Unknown Primary Neoplasms, UPC, Unknown Primary Cancer, Questionnaire, Gemcitabine, Gemcitabine Hydrochloride, Gemzar, Oxaliplatin, Eloxatin, Gemox
- Medical subject headings
- Neoplasms, Unknown Primary
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gemcitabine (Gemox)Drug
Also called Gemcitabine Hydrochloride, Gemzar
1000 mg/m^2, infused at 10 mg/m^2/min on Day 1 repeated every 14 days (one cycle).
OxaliplatinDrug
Also called Eloxatin
100 mg/m^2 by vein infused on Day 2 over two hours, repeated every 14 days (one cycle).
QuestionnaireBehavioural
Quality of Life Surveys
| Study group | Role | What they receive |
|---|---|---|
| Gemcitabine + Oxaliplatin | Experimental | Gemcitabine 1000 mg/m^2, infused at 10 mg/m^2/min on Day 1 and Oxaliplatin 100 mg/m^2 by vein infused on Day 2 over two hours. Repeated every 14 days (one cycle). Receives: Drug: Gemcitabine (Gemox); Drug: Oxaliplatin; Behavioral: Questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
Participants' Response
Complete Response (CR): Disappearance of all target lesions; Partial Response (PR): At least 30% decrease in sum of longest diameter (LD) of target lesions, reference baseline sum LD; Progressive Disease (PD): At least 20% increase in sum of LD of target lesions, reference smallest sum LD recorded since treatment started or appearance of 1 or more new lesions; Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor increase to qualify for PD, reference smallest sum LD since treatment started.
Measured: Response to treatment measured using Response Evaluation Criteria in Solid Tumors (RECIST) criteria with radiological evaluation at 6 weeks and reevaluated every 6 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2006 (estimated)
- Study startFeb 2004
- Primary completionMar 2007
- Study completionJan 2010
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 Unknown Primary NeoplasmsStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe 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 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- Sanofi-Synthelabo
- Responsible party
- Sponsor
- Investigators
- Gauri R. Varadhachary, MD, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00353145
- Sponsor's protocol ID
- 2003-0946
- Status last verified
- Aug 2012
- First submitted
- 13 Jul 2006
- Last updated
- 2 Aug 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
Carlson H, Lenzi R, Raber MN, Varadhachary GR. A phase II study to evaluate the efficacy and toxicity of oxaliplatin in combination with gemcitabine in carcinoma of unknown primary. Int J Clin Oncol. 2013 Apr;18(2):226-31. doi: 10.1007/s10147-011-0366-4. Epub 2012 Jan 5.
PubMed 22218909
Study at a glance
From the registry record, last updated by the sponsor on 2 Aug 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Study to Evaluate the Efficacy and Toxicity of Oxaliplatin in Combination With Gemcitabine as First and Second Line Therapy in Unknown Primary Cancer
- ClinicalTrials.gov ID
- NCT00353145
- Acronym / sponsor ID
- 2003-0946
- Conditions
- Unknown Primary Neoplasms
- Keywords
- Unknown Primary Neoplasms, UPC, Unknown Primary Cancer, Questionnaire, Gemcitabine, Gemcitabine Hydrochloride, Gemzar, Oxaliplatin
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 29 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Collaborators
- Sanofi-Synthelabo
- Study start
- Feb 2004
- Primary completion
- Mar 2007 (actual)
- Study completion
- Jan 2010 (actual)
- First posted
- 17 Jul 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.
Primary objectives:
- To determine the overall tumor response rate with oxaliplatin in combination with gemcitabine (GEMOX) as first line and second line therapy in unknown primary cancer (UPC).
- To determine the tolerability (toxicity) of this regimen in this patient population.
Secondary objectives:
- To determine the median overall survival (OS) and time to progression (TTP) for patients treated with this combination.
- To determine the impact of this combination on quality of life (QOL) in this patient population.
Detailed description
Oxaliplatin is a chemotherapy drug that causes the death of cancer cells and other actively dividing cells by interfering with Deoxyribonucleic acid (DNA) function. Gemcitabine prevents cells from making DNA and Ribonucleic acid (RNA) that are necessary for cell growth, thus disrupting the growth of the cancer cells, which causes the cancer cells to start to die.
After the screening portion of the study, if you are eligible to begin study treatment, you will come to M. D. Anderson at least every two weeks (14 days) for treatment. Each 14-day period of treatment is called a "cycle" of therapy. You will receive at least 3 cycles of therapy (6 weeks) unless side effects become intolerable or the disease progresses.
When you begin treatment, you will have a small tube (central venous line) inserted into a large vein under the skin of the chest or through a vein in the arm for administration of oxaliplatin and gemcitabine. The central venous line will remain in place the entire time you are taking part in this study. Both drugs must be given at M. D. Anderson. On Day 1 of each cycle, you will receive gemcitabine injected into a vein over 2 hours. On Day 2 of each cycle you will receive oxaliplatin injected into a vein over 2 hours. This drug schedule will be repeated every 2 weeks.
You will first be asked to fill out several questionnaires that deal with your quality of life. These will help the researchers understand how the study drugs affect your quality of life including your pain level, fatigue (tiredness) level, appetite, and ability to perform everyday tasks, in spite of whether there is any shrinkage of the tumor. It will take about 30 minutes to an hour to complete the forms. You will also be asked to complete a questionnaire (one time only) that asks questions about why you decided to take part in this study.
During the first cycle of therapy, blood (about 2 1/2 teaspoons) will be collected once a week for routine tests. Before each new cycle of therapy, you will have a complete physical exam, urine will be collected, and blood will be drawn (about 2 ½ teaspoons) for routine tests. You will be asked to tell the study doctor about all medications you have taken since you started taking the study drugs and any health problems that you may have experienced. You will also have either computed tomography (CT) scans or an Magnetic resonance imaging (MRI) of the tumor(s) every 6 weeks and at the end of the study.
All tests before each new cycle of treatment and when treatment stops must be done at M. D. Anderson. Extra tests may be done during the study if your doctor feels it is necessary for your care. Every 6 weeks for as long as you are on study, you will also be asked to fill out the questionnaires that help study doctors understand your quality of life. It will take about 30 minutes to an hour to complete the forms.
If you experience intolerable side effects, treatment may be delayed, stopped, or you may receive smaller doses of the treatment. You may continue to receive treatment on this study, unless the disease gets worse or you experience any intolerable side effects. If this happens, you will be taken off the study and your doctor will discuss other treatment options with you.
When you stop taking part in the study for any reason, you will have blood (about 3 teaspoons) collected for final routine tests. You will have one more physical exam and either a CT scan or a MRI to check on the status of the disease. You will also be asked once more to fill out the questionnaires that help assess your quality of life. It will take about 30 minutes to an hour to complete the forms.
Once you stop receiving study treatment, you will be contacted by phone every three months for the rest of your life to check on how you are doing and any symptoms you may be experiencing.
This is an investigational study. Oxaliplatin is FDA approved for treatment of advanced cancer of the colon or rectum, and gemcitabine is FDA approved for the treatment of advanced cancer of the pancreas. However, the combination of the two drugs for treatment of cancers with unknown primaries is still considered investigational. Up to 81 people will take part in this study. All will be enrolled at M. D. Anderson.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Gemcitabine + Oxaliplatin | Experimental | Drug: Gemcitabine (Gemox), Drug: Oxaliplatin, Behavioral: QuestionnaireGemcitabine 1000 mg/m^2, infused at 10 mg/m^2/min on Day 1 and Oxaliplatin 100 mg/m^2 by vein infused on Day 2 over two hours. Repeated every 14 days (one cycle). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Age >/= 18 years old.
- Signed informed consent/authorization is obtained prior to conducting any study-specific screening procedures.
- Patients should fulfill the criteria for UPC: no primary detected after a complete evaluation which is defined as complete history and physical, detailed laboratory examination, directed radiologic studies, symptom or sign directed invasive studies, directed immunohistochemistry studies and serum tumor markers.
- Previously untreated or has received no more than one prior chemotherapy regimen for unknown primary cancer. If the patients are previously treated, they may not have had previous exposure to gemcitabine or oxaliplatin. Prior exposure to cisplatin or carboplatin is allowed for this study.
- ECOG performance status must be 0-2 (Appendix A).
Key exclusion criteria (9 listed)
- In previously treated patients; patients should not have received gemcitabine or oxaliplatin as one of the agents.
- Uncontrolled intercurrent illness including, but not limited to, active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmias not well controlled with medication, myocardial infarction within the previous 6 months, or psychiatric illness/social situations that would limit compliance with study requirements.
- Patients with known brain metastases should be excluded from this clinical trial because of their poor prognosis and because they often develop progressive neurological dysfunction that would confound the evaluation of neurological and other adverse events. A CT scan of the brain is not needed for eligibility and will be done only if the patient presents with symptoms suggestive of brain metastases.
- Patients who have had chemotherapy within 4 weeks (6 weeks for nitrosoureas or mitomycin C) prior to entering the study or those who have not recovered from adverse events due to agents administered more than 28 days earlier.
- Patients may not be receiving any other investigational agents, or have participated in any investigational drug study within 28 days preceding start of study treatment.
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 (Gemox)Also: Gemcitabine Hydrochloride, Gemzar1000 mg/m^2, infused at 10 mg/m^2/min on Day 1 repeated every 14 days (one cycle). | Drug | Gemcitabine + Oxaliplatin |
| OxaliplatinAlso: Eloxatin100 mg/m^2 by vein infused on Day 2 over two hours, repeated every 14 days (one cycle). | Drug | Gemcitabine + Oxaliplatin |
| QuestionnaireQuality of Life Surveys | Behavioural | Gemcitabine + Oxaliplatin |
Primary outcome
Participants' Response
Time frame: Response to treatment measured using Response Evaluation Criteria in Solid Tumors (RECIST) criteria with radiological evaluation at 6 weeks and reevaluated every 6 weeks.
Complete Response (CR): Disappearance of all target lesions; Partial Response (PR): At least 30% decrease in sum of longest diameter (LD) of target lesions, reference baseline sum LD; Progressive Disease (PD): At least 20% increase in sum of LD of target lesions, reference smallest sum LD recorded since treatment started or appearance of 1 or more new lesions; Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor increase to qualify for PD, reference smallest sum LD since treatment started.
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 2 Aug 2012.
- Derived from this study: PubMed 22218909Carlson H, Lenzi R, Raber MN, Varadhachary GR. A phase II study to evaluate the efficacy and toxicity of oxaliplatin in combination with gemcitabine in carcinoma of unknown primary. Int J Clin Oncol. 2013 Apr;18(2):226-31. doi: 10.1007/s10147-011-0366-4. Epub 2012 Jan 5.
- UT MD Anderson Cancer Center websiteLink provided by the sponsor.
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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.
Gauri R. Varadhachary, MD principal investigator
M.D. Anderson Cancer Center
1 site 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 (Gemox), Oxaliplatin and Questionnaire in people with Unknown Primary Neoplasms, run by M.D. Anderson Cancer Center 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 9 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 2 Aug 2012. 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 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?
Participants' Response (time frame: Response to treatment measured using Response Evaluation Criteria in Solid Tumors (RECIST) criteria with radiological evaluation at 6 weeks and reevaluated every 6 weeks.). 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 NCT00353145, 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 2 Aug 2012.