Solid TumorPhase 1NCT00215501
Capecitabine or 5-Fluorouracil in Combination With Irinotecan and Cisplatin in Patients With Solid Tumor Malignancies
A Phase 1 study testing Capecitabine, 5-Fluorouracil (5-FU) and Irinotecan in people with Solid Tumor, run by Dana-Farber Cancer Institute at 3 sites in United States.
Trial summary
The purpose of this study is to test the safety of irinotecan and cisplatin in combination with either capecitabine or continuous infusion 5-fluorouracil and to see what effects (good and bad) these have on patients with unresectable, advanced solid tumors. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Solid Tumor
- What is being tested?
- Capecitabine, 5-Fluorouracil (5-FU) and Irinotecan
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- 3 sitesUnited States
- Study dates
- Nov 2001to Sep 2008
- 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
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically confirmed solid tumor malignancy
- 18 years of age or older
- Two prior chemotherapy regimens for metastatic disease. Prior chemotherapy must have been completed at least 3 weeks prior to initiation of this protocol.
- ECOG performance status of 0,1 or 2
- Neutrophils greater or equal to 1,500/ul
- Platelets greater or equal to 100,000/ul
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- Serum bilirubin less or equal to 1.5 mg/dl
- Creatinine clearance greater than 50 ml/min
- AST or SGOT less or equl to 3x ULN
- Prior radiotherapy is allowable, provided at least 4 weeks have elapsed and the patient has recovered from all therapy related side effects.
Who cannot join
- Life expectancy of less than 3 months
- Clinically significant cardiac disease or myocardial infarction within past 6 months
- Suspicion or documentation of CNS metastases or carcinomatous meningitis
- Psychiatric disability judged by the investigator to be clinically significant, precluding informed consent
- Known existing coagulopathy and/or requires therapeutic anticoagulants
- Uncontrolled diarrhea
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- Peripheral neuropathy
- Major surgery within 3 weeks of the state of the study treatment without complete recovery
- Serious, uncontrolled, concurrent infection
- Lack of physical integrity of upper gastrointestinal tract or malabsorption syndrome
- Prior severe reaction to fluoropyrimidine, irinotecan or cisplatin
- Known interstitial pulmonary fibrosis
- Known Gilbert's disease
- Uncontrolled diabetes mellitus
- Organ allograft(s) on immunosuppressive therapy
- Pregnant or lactating women
- Patients taking valproic acid
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Massachusetts General Hospital
Boston, Massachusetts, 02114
Brigham and Women's Hospital
Boston, Massachusetts, 02115
Dana-Farber Cancer Institute
Boston, Massachusetts, 02115
About this study
Official title: A Phase I Trial of Capecitabine or Continuous Infusion 5-Fluorouracil in Combination With Weekly Irinotecan and Cisplatin in Patients With Advanced Solid Tumor Malignancies
The purpose of this study is to test the safety of irinotecan and cisplatin in combination with either capecitabine or continuous infusion 5-fluorouracil and to see what effects (good and bad) these have on patients with unresectable, advanced solid tumors.
Read the detailed description
- This is a Phase I dose escalation study. The dose of drug the patient receives will be assigned based upon when they enter the study. Since we are looking for the highest dose of capecitabine or 5-fluorouracil that can be given safely in combination with cisplatin and irinotecan, not everyone who participates in this study will be receiving the same amount of the drug.
- There are four parts to this study: 1)Choice of treatment, 2)Evaluation, 3)Chemotherapy and 4)Follow-up.
- The patient and the patient's doctor will decide which form of chemotherapy is best for the patient, either pill form or continuous infusion. Chemotherapy pills (capecitabine) are given twice per day for 14 days is a row every 3 weeks. Continuous infusion (5-fluorouracil) is given through a pump 24 hours a day for 14 days every 3 weeks.
- Prior to initiation to therapy the extent of the patients cancer will be evaluated. This includes a CT scan, chest x-ray, EKG and bloodwork.
- Patient's will receive chemotherapy for 2 weeks followed by a one week break. This will constitute one cycle. The medications cisplatin and irinotecan will be given intravenously on the 1st and 8th day of each cycle. Following the rest period the next cycle of chemotherapy begins.
- Following 2 cycles of chemotherapy, the patients cancer will be re-evaluated. A CT scan and bloodwork will be obtained and will be compared to the previous studies. Treatment will resume if the cancer is the same size or smaller than before and the patient is tolerating the chemotherapy well. The cancer will be re-evaluated every 2 cycles of chemotherapy.
- Conditions
- Solid Tumor
- Being tested
- Capecitabine, 5-Fluorouracil (5-FU), Irinotecan, Cisplatin
- Keywords
- advanced solid tumor malignancy, capecitabine, continuous infusion, 5-FU, irinotecan, 5-fluorouracil, cisplatin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CapecitabineDrug
Orally twice a day for 14 days (dosage will vary)
5-Fluorouracil (5-FU)Drug
Continuous infusion 24 hours a day for 14 days (Days 1-14) Dosage will vary
IrinotecanDrug
Intravenously weekly for 2 weeks (given after cisplatin) followed by a one-week rest period
CisplatinDrug
Intravenously weekly for 2 weeks followed by a one week rest period
| Study group | Role | What they receive |
|---|---|---|
| Group A | Experimental | Oral capecitabine Receives: Drug: Capecitabine; Drug: Irinotecan; Drug: Cisplatin |
| Group B | Experimental | 5-fluorouracil Receives: Drug: 5-Fluorouracil (5-FU); Drug: Irinotecan; Drug: Cisplatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine dose limiting toxicity, maximum tolerated dose and recommended Phase II dose of both capecitabine and 5-fluorouracil in this patient population.
Measured: 2 years
Secondary outcomes (1)
To make a preliminary assessment of the anti-tumor activity of these combinations.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2005 (estimated)
- Study startNov 2001
- Primary completionSep 2005
- Study completionSep 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Solid TumorStudies of the same condition, open and under way.
- More trials run by Dana-Farber Cancer InstituteThe 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dana-Farber Cancer Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Brigham and Women's Hospital, Massachusetts General Hospital
- Responsible party
- Principal investigator, Peter C. Enzinger, MD, Dana-Farber Cancer Institute
- Investigators
- Peter C. Enzinger, MD, Principal investigator, Dana-Farber Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00215501
- Sponsor's protocol ID
- 01-042
- Status last verified
- Oct 2018
- First submitted
- 14 Sep 2005
- Last updated
- 2 Nov 2018
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Trial of Capecitabine or Continuous Infusion 5-Fluorouracil in Combination With Weekly Irinotecan and Cisplatin in Patients With Advanced Solid Tumor Malignancies
- ClinicalTrials.gov ID
- NCT00215501
- Acronym / sponsor ID
- 01-042
- Conditions
- Solid Tumor
- Keywords
- advanced solid tumor malignancy, capecitabine, continuous infusion, 5-FU, irinotecan, 5-fluorouracil, cisplatin
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- Dana-Farber Cancer InstituteUniversity, hospital or other
- Collaborators
- Brigham and Women's Hospital, Massachusetts General Hospital
- Study start
- Nov 2001
- Primary completion
- Sep 2005 (actual)
- Study completion
- Sep 2008 (actual)
- First posted
- 22 Sep 2005 (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 purpose of this study is to test the safety of irinotecan and cisplatin in combination with either capecitabine or continuous infusion 5-fluorouracil and to see what effects (good and bad) these have on patients with unresectable, advanced solid tumors.
Detailed description
- This is a Phase I dose escalation study. The dose of drug the patient receives will be assigned based upon when they enter the study. Since we are looking for the highest dose of capecitabine or 5-fluorouracil that can be given safely in combination with cisplatin and irinotecan, not everyone who participates in this study will be receiving the same amount of the drug.
- There are four parts to this study: 1)Choice of treatment, 2)Evaluation, 3)Chemotherapy and 4)Follow-up.
- The patient and the patient's doctor will decide which form of chemotherapy is best for the patient, either pill form or continuous infusion. Chemotherapy pills (capecitabine) are given twice per day for 14 days is a row every 3 weeks. Continuous infusion (5-fluorouracil) is given through a pump 24 hours a day for 14 days every 3 weeks.
- Prior to initiation to therapy the extent of the patients cancer will be evaluated. This includes a CT scan, chest x-ray, EKG and bloodwork.
- Patient's will receive chemotherapy for 2 weeks followed by a one week break. This will constitute one cycle. The medications cisplatin and irinotecan will be given intravenously on the 1st and 8th day of each cycle. Following the rest period the next cycle of chemotherapy begins.
- Following 2 cycles of chemotherapy, the patients cancer will be re-evaluated. A CT scan and bloodwork will be obtained and will be compared to the previous studies. Treatment will resume if the cancer is the same size or smaller than before and the patient is tolerating the chemotherapy well. The cancer will be re-evaluated every 2 cycles of chemotherapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A | Experimental | Drug: Capecitabine, Drug: Irinotecan, Drug: CisplatinOral capecitabine |
| Group B | Experimental | Drug: 5-Fluorouracil (5-FU), Drug: Irinotecan, Drug: Cisplatin5-fluorouracil |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Histologically confirmed solid tumor malignancy
- 18 years of age or older
- Two prior chemotherapy regimens for metastatic disease. Prior chemotherapy must have been completed at least 3 weeks prior to initiation of this protocol.
- ECOG performance status of 0,1 or 2
- Neutrophils greater or equal to 1,500/ul
Key exclusion criteria (17 listed)
- Life expectancy of less than 3 months
- Clinically significant cardiac disease or myocardial infarction within past 6 months
- Suspicion or documentation of CNS metastases or carcinomatous meningitis
- Psychiatric disability judged by the investigator to be clinically significant, precluding informed consent
- Known existing coagulopathy and/or requires therapeutic anticoagulants
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 |
|---|---|---|
| CapecitabineOrally twice a day for 14 days (dosage will vary) | Drug | Group A |
| 5-Fluorouracil (5-FU)Continuous infusion 24 hours a day for 14 days (Days 1-14) Dosage will vary | Drug | Group B |
| IrinotecanIntravenously weekly for 2 weeks (given after cisplatin) followed by a one-week rest period | Drug | Group A, Group B |
| CisplatinIntravenously weekly for 2 weeks followed by a one week rest period | Drug | Group A, Group B |
Primary outcome
To determine dose limiting toxicity, maximum tolerated dose and recommended Phase II dose of both capecitabine and 5-fluorouracil in this patient population.
Time frame: 2 years
1 secondary outcome
To make a preliminary assessment of the anti-tumor activity of these combinations.
Time frame: 2 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 2 Nov 2018.
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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 C. Enzinger, MD principal investigator
Dana-Farber Cancer Institute
3 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 Capecitabine, 5-Fluorouracil (5-FU) and Irinotecan in people with Solid Tumor, run by Dana-Farber Cancer Institute at 3 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 10 inclusion and 17 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 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 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?
To determine dose limiting toxicity, maximum tolerated dose and recommended Phase II dose of both capecitabine and 5-fluorouracil in this patient population. (time frame: 2 years). 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 2 Nov 2018.