LymphomaPhase 1NCT00005021
Combination Chemotherapy With or Without Biological Therapy in Treating Patients With Refractory Solid Tumor or Lymphoma
A Phase 1 study testing filgrastim, carboplatin and paclitaxel in people with Lymphoma and Small Intestine Cancer, run by Fox Chase Cancer Center at 1 site in United States.
Trial summary
RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Combining more than one drug, giving the drugs in different ways, and combining biological therapy with 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
- Lymphoma, Small Intestine Cancer, Unspecified Adult Solid Tumor, Protocol Specific
- What is being tested?
- filgrastim, carboplatin and paclitaxel
- How many people
- 17 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 1996to May 2003
- 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
DISEASE CHARACTERISTICS: Histologically proven advanced solid tumor or lymphoma that is refractory to standard therapy or for which no standard therapy exists or for which the drugs used in this regimen constitute standard therapy Brain metastasis eligible provided: Evidence of neurologic improvement or normalization No evidence of radiographic progression after appropriate therapy Steroid dose stable (if given)
PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0 or 1 Life expectancy: Greater than 3 months Hematopoietic: Absolute granulocyte count at least 2,000/mm2 Platelet count at least 100,000/mm2 Hepatic: Bilirubin no greater than 1.5 mg/dL Transaminases less than 3 times normal Renal: Creatinine no greater than 1.5 mg/dL OR Creatinine clearance at least 60 mL/min Cardiovascular: No myocardial infarction within 6 months No history of congestive heart failure No uncontrolled angina No uncontrolled arrhythmia Other: No concurrent medical illness or active infection that would render treatment unsafe Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception
PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: Prior topotecan, paclitaxel, and carboplatin allowed if progression observed greater than 3 months after last dose No prior mitomycin or nitrosoureas No more than 1 prior chemotherapy regimen At least 4 weeks since chemotherapy and recovered (alopecia allowed) Endocrine therapy: Not specified Radiotherapy: No prior radiotherapy to more than 25% of bone marrow At least 4 weeks since radiotherapy and recovered (alopecia allowed) Surgery: Not specified
Trial locations and contacts
1 site in 1 country.
United States1 site
Fox Chase Cancer Center
Philadelphia, Pennsylvania, 19111
About this study
Official title: Phase I Evaluation of Topotecan in Combination With Paclitaxel and Carboplatin
RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Combining more than one drug, giving the drugs in different ways, and combining biological therapy with chemotherapy may kill more cancer cells.
PURPOSE: Phase I trial to study the effectiveness of topotecan, paclitaxel, and carboplatin with or without filgrastim in treating patients who have advanced solid tumor or lymphoma that has not responded to standard therapy.
Read the detailed description
OBJECTIVES: I. Determine the maximum tolerated doses of combined topotecan, paclitaxel, and carboplatin (TOPO/TAX/CBDCA) with or without filgrastim (G-CSF) in patients with advanced solid tumors or lymphomas. II. Determine the toxic effects of this regimen in these patients. III. Determine the pharmacokinetics of TOPO/TAX/CBDCA and whether TAX/CBDCA will affect the pharmacokinetics of TOPO on day 1 as compared to TOPO administered alone on day 3. IV. Describe any clinical responses observed in these patients.
OUTLINE: This is a dose escalation study of the combination topotecan/paclitaxel/carboplatin. Patients are stratified according to prior chemotherapy and radiotherapy (yes vs no). Part I: Patients receive topotecan IV on days 1-3 and paclitaxel IV over 3 hours and carboplatin IV over 30-60 minutes, on day 1. Part II: Patients receive topotecan, paclitaxel, and carboplatin as in part I, plus filgrastim (G-CSF) on days 6-19. Treatment repeats every 3 weeks in the absence of disease progression or unacceptable toxicity Cohorts of 3-6 patients receive escalating doses of topotecan/paclitaxel/carboplatin until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose limiting toxicity.
PROJECTED ACCRUAL: Approximately 20-30 patients will be accrued for this study within 4 years.
- Being tested
- filgrastim, carboplatin, paclitaxel, topotecan hydrochloride
- Keywords
- stage III adult Hodgkin lymphoma, stage IV adult Hodgkin lymphoma, recurrent adult Hodgkin lymphoma, stage III cutaneous T-cell non-Hodgkin lymphoma, stage IV cutaneous T-cell non-Hodgkin lymphoma, recurrent cutaneous T-cell non-Hodgkin lymphoma, small intestine lymphoma, unspecified adult solid tumor, protocol specific, stage III grade 1 follicular lymphoma, stage III grade 2 follicular lymphoma, stage III grade 3 follicular lymphoma, stage III adult diffuse small cleaved cell lymphoma, stage III adult diffuse mixed cell lymphoma, stage III adult diffuse large cell lymphoma, stage III adult immunoblastic large cell lymphoma, stage III adult lymphoblastic lymphoma, stage III adult Burkitt lymphoma, stage IV grade 1 follicular lymphoma, stage IV grade 2 follicular lymphoma, stage IV grade 3 follicular lymphoma
- Medical subject headings
- Lymphoma, Hodgkin Disease, Lymphoma, T-Cell, Cutaneous, Lymphoma, Follicular, Lymphoma, Non-Hodgkin, Lymphoma, Large B-Cell, Diffuse, Lymphoma, Large-Cell, Immunoblastic, Precursor Cell Lymphoblastic Leukemia-Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
filgrastimBiological
carboplatinDrug
paclitaxelDrug
topotecan hydrochlorideDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2004 (estimated)
- Study startJul 1996
- Primary completionMay 2003
- Study completionMay 2003
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for LymphomaStudies of the same condition, open and under way.
- More trials run by Fox Chase 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 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fox Chase Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Corey J. Langer, MD, Study chair, Fox Chase Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00005021
- Sponsor's protocol ID
- FCCC-96004
- Other IDs
- CDR0000064913, NCI-T95-0075H
- Status last verified
- Jul 2013
- First submitted
- 6 Apr 2000
- Last updated
- 11 Jul 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I Evaluation of Topotecan in Combination With Paclitaxel and Carboplatin
- ClinicalTrials.gov ID
- NCT00005021
- Acronym / sponsor ID
- FCCC-96004
- Keywords
- stage III adult Hodgkin lymphoma, stage IV adult Hodgkin lymphoma, recurrent adult Hodgkin lymphoma, stage III cutaneous T-cell non-Hodgkin lymphoma, stage IV cutaneous T-cell non-Hodgkin lymphoma, recurrent cutaneous T-cell non-Hodgkin lymphoma, small intestine lymphoma, unspecified adult solid tumor, protocol specific
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- Fox Chase Cancer CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Jul 1996
- Primary completion
- May 2003 (actual)
- Study completion
- May 2003 (actual)
- First posted
- 3 May 2004 (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 use different ways to stop cancer cells from dividing so they stop growing or die. Combining more than one drug, giving the drugs in different ways, and combining biological therapy with chemotherapy may kill more cancer cells.
PURPOSE: Phase I trial to study the effectiveness of topotecan, paclitaxel, and carboplatin with or without filgrastim in treating patients who have advanced solid tumor or lymphoma that has not responded to standard therapy.
Detailed description
OBJECTIVES: I. Determine the maximum tolerated doses of combined topotecan, paclitaxel, and carboplatin (TOPO/TAX/CBDCA) with or without filgrastim (G-CSF) in patients with advanced solid tumors or lymphomas. II. Determine the toxic effects of this regimen in these patients. III. Determine the pharmacokinetics of TOPO/TAX/CBDCA and whether TAX/CBDCA will affect the pharmacokinetics of TOPO on day 1 as compared to TOPO administered alone on day 3. IV. Describe any clinical responses observed in these patients.
OUTLINE: This is a dose escalation study of the combination topotecan/paclitaxel/carboplatin. Patients are stratified according to prior chemotherapy and radiotherapy (yes vs no). Part I: Patients receive topotecan IV on days 1-3 and paclitaxel IV over 3 hours and carboplatin IV over 30-60 minutes, on day 1. Part II: Patients receive topotecan, paclitaxel, and carboplatin as in part I, plus filgrastim (G-CSF) on days 6-19. Treatment repeats every 3 weeks in the absence of disease progression or unacceptable toxicity Cohorts of 3-6 patients receive escalating doses of topotecan/paclitaxel/carboplatin until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose limiting toxicity.
PROJECTED ACCRUAL: Approximately 20-30 patients will be accrued for this study within 4 years.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- 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 |
|---|---|---|
| filgrastim | Biological | – |
| carboplatin | Drug | – |
| paclitaxel | Drug | – |
| topotecan hydrochloride | Drug | – |
Primary outcome
Not reported in the source record.
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 11 Jul 2013.
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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.
Corey J. Langer, MD study chair
Fox Chase 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 1 study testing filgrastim, carboplatin and paclitaxel in people with Lymphoma and Small Intestine Cancer, run by Fox Chase 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?
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 11 Jul 2013. 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 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.
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 11 Jul 2013.