CancerPhase 1NCT00002854
High-Dose Combination Chemotherapy Plus Peripheral Stem Cell Transplantation in Treating Patients With Advanced Cancer
A Phase 1 study testing filgrastim, carboplatin and cisplatin in people with Cancer, run by City of Hope Medical Center at 1 site in United States.
Trial summary
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Peripheral stem cell transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more tumor cells. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Cancer
- What is being tested?
- filgrastim, carboplatin and cisplatin
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 1994to Aug 2015
- 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 to 55 years
- All sexes
- No healthy volunteers
- Adult
DISEASE CHARACTERISTICS:
- Histologically confirmed advanced carcinomas of the following types:
- Breast carcinoma that is ineligible for or patient has refused participation in a higher priority protocol in the following categories:
- Stage II disease with at least 10 involved lymph nodes and no evidence of disease (NED) following surgery
- Stage III disease rendered surgically NED with or without radiotherapy
- Stage IV disease following partial response (PR) or complete response (CR) to surgery, chemotherapy, or radiotherapy
- Prior high dose chemotherapy allowed at discretion of investigator
- No chemoresistant disease rendered surgically NED
- Locoregionally recurrent disease within 2 years of breast conservation with or without chemotherapy
- Stage III/IV ovarian cancer
- PR/CR following debulking surgery and/or chemotherapy
- Ineligible for or refused participation in higher priority protocols
- Primary soft tissue sarcoma with high-grade disease greater than 10 cm or that is metastatic
- Rendered surgically NED or achieved PR/CR on any chemotherapeutic or immunotherapeutic regimen
- Ineligible for or refused participation in higher priority protocols
- Malignant melanoma in the following categories:
- Ulcerative primary tumor with any number of completely resected metastatic lymph nodes
- Stage II disease with more than 4 involved nodes rendered NED
- Stage III disease rendered surgically NED or achieved PR/CR on any chemotherapeutic or immunotherapeutic regimen
- Osteosarcoma that is ineligible for or refused participation in higher priority protocols
- Resected primary with less than 50% tumor necrosis on pathologic review
- Metastatic disease rendered surgically NED or PR/CR on any chemotherapeutic, radiotherapeutic, or immunotherapeutic regimen
- The following diseases rendered surgically NED or that achieved PR/CR on any chemotherapeutic, radiotherapeutic, or immunotherapeutic regimen also eligible:
- Small cell bone carcinoma
- Metastatic Ewing's sarcoma
- Metastatic gastrointestinal malignancy
- Recurrent Wilms' tumor
- No CNS metastases
- No current histologically confirmed bone marrow metastases
- Prior bone metastases with resolution at time of entry permitted
PATIENT CHARACTERISTICS:
Age:
- Physiologic 18 to 55
Performance status:
- Karnofsky 80%-100%
Hematopoietic:
- Absolute neutrophil count greater than 1,500/mm3
- Platelet count greater than 120,000/mm3
- Hemoglobin greater than 10 g/dL
Hepatic:
- Bilirubin less than 1.5 mg/dL
- AST/ALT less than 3 times normal
Renal:
- Creatinine less than 1.4 mg/dL
- Creatinine clearance at least 70 mL/min
- No history of hemorrhagic cystitis
Cardiovascular:
- Ejection fraction at least 55% by MUGA
- No significant cardiac disease
Pulmonary:
- FEV1 greater than 2 L
- pO2 (room air) greater than 70 mm Hg
- pCO2 (room air) less than 42 mm Hg
- DLCO greater than 60% of predicted
Other:
- No potentially disabling psychosocial history
- No organic or functional CNS dysfunction or other medical problem that would present party at undue risk
- HIV negative
- Hepatitis B surface antigen negative
- No hearing loss greater than 40 decibels
- No contraindication to the following procedures:
- Collection by apheresis of up to 16 x 10 to the 8th mononuclear cells mobilized by G-CSF
- Collection of autologous bone marrow, if needed
- No second malignancy except:
- Nonmelanomatous skin cancer
- Carcinoma in situ of the cervix
- Not pregnant or nursing
- Adequate contraception required of fertile patients
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- See Disease Characteristics
- At least 4 weeks since prior immunotherapy
Chemotherapy:
- See Disease Characteristics
- No more than 3 prior chemotherapy regimens (excluding adjuvant therapy)
- No more than 200 mg per square meter of prior cisplatin
- No more than 800 mg per square meter of prior carboplatin
- No prior exposure to greater than 1,000 mg per square meter of "24-hour paclitaxel equivalents" (using a 1:1.3 ratio between paclitaxel doses given by 24-hour infusion and by 3-hour infusion)
- At least 4 weeks since prior chemotherapy
Endocrine therapy:
- Not specified
Radiotherapy:
- No prior radiotherapy to more than 20% of bone marrow
- At least 4 weeks since prior radiotherapy
Surgery:
- See Disease Characteristics
Trial locations and contacts
1 site in 1 country.
United States1 site
City of Hope Comprehensive Cancer Center
Duarte, California, 91010-3000
About this study
Official title: PHASE I PILOT STUDY OF SEQUENTIAL HIGH DOSE CYCLES OF CISPLATIN, CYCLOPHOSPHAMIDE, ETOPOSIDE AND IFOSFAMIDE, CARBOPLATIN AND TAXOL WITH AUTOLOGOUS STEM CELL SUPPORT
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Peripheral stem cell transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more tumor cells.
PURPOSE: Phase I trial to study the effectiveness of combination chemotherapy plus peripheral stem cell transplantation in treating patients who have advanced cancer.
Read the detailed description
OBJECTIVES:
- Evaluate the feasibility of administering 2 courses of high dose chemotherapy consisting of etoposide, cisplatin, and cyclophosphamide followed by ifosfamide, carboplatin, and paclitaxel (IC-T), each administered with filgrastim (G-CSF) and autologous stem cell support, to patients with advanced carcinomas.
- Describe the toxicity of these high dose chemotherapy regimens.
- Define the maximum tolerated dose of paclitaxel deliverable in this high dose regimen.
- Describe the pharmacokinetics of escalating doses of paclitaxel given as a 24-hour continuous infusion.
- Determine the disposition of carboplatin administered in the IC-T regimen.
OUTLINE: At least 4 weeks prior to chemotherapy, patients undergo stem cell collection following filgrastim (G-CSF) mobilization. Sufficient stem cells to support 2 courses of chemotherapy are required. Autologous bone marrow is collected as an adjuvant if stem cell harvest is inadequate.
Patients then receive high dose cisplatin, etoposide, and cyclophosphamide over 10 days, followed the next day by infusion of one fourth of the allotted stem cells, with the remaining allotment infused 2 days later. G-CSF is given for granulocyte support.
Beginning no sooner than 14 weeks from the start of the first course of chemotherapy, stable and responding patients receive high dose paclitaxel, carboplatin, and ifosfamide over 5 days, followed 2 days later with one-fourth of the allotted stem cells, with the remaining allotment infused the following day. G-CSF is given for granulocyte support. Groups of 3-6 patients are treated with escalating doses of paclitaxel until the maximum tolerated dose for this regimen is determined.
Patients are followed monthly for 1 year, every 3 months for 1 year, then as needed at the physician's discretion for at least 5 years.
PROJECTED ACCRUAL: Three to six patients will be entered at each dose of paclitaxel studied.
- Conditions
- Cancer
- Being tested
- filgrastim, carboplatin, cisplatin, cyclophosphamide, etoposide
- Keywords
- stage IV colon cancer, stage II breast cancer, stage IV breast cancer, stage IIIA breast cancer, recurrent breast cancer, stage IV gastric cancer, recurrent gastric cancer, localized osteosarcoma, metastatic osteosarcoma, stage IIIB breast cancer, recurrent pancreatic cancer, stage IV rectal cancer, recurrent colon cancer, recurrent rectal cancer, stage IV anal cancer, recurrent anal cancer, stage IV esophageal cancer, recurrent esophageal cancer, stage III adult soft tissue sarcoma, recurrent adult soft tissue sarcoma
- Medical subject headings
- Neoplasms, Colonic Neoplasms, Breast Neoplasms, Stomach Neoplasms, Osteosarcoma, Pancreatic Neoplasms, Rectal Neoplasms, Anus Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
filgrastimBiological
carboplatinDrug
cisplatinDrug
cyclophosphamideDrug
etoposideDrug
ifosfamideDrug
mesnaDrug
paclitaxelDrug
peripheral blood stem cell transplantationProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Sequential high dose chemotherapy | Experimental | Not described Receives: Biological: filgrastim; Drug: carboplatin; Drug: cisplatin; Drug: cyclophosphamide; Drug: etoposide; Drug: ifosfamide; Drug: mesna; Drug: paclitaxel; Procedure: peripheral blood stem cell transplantation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of two cycles of high dose chemotherapy with stem cell reinfusion
Measured: 30 days from start of course II of treatment
Toxicity of two cycles of high dose chemothearpy and stem cell reinfusion
Toxicity graded according to the NCI Common Toxicity Criteria and amended for subjects undergoing transplantation
Measured: 30 days from start of course II of treatment
Maximum tolerated dose of two cycles of high dose chemothearpy and stem cell reinfusion
Measured: 30 days from start of course II of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2003 (estimated)
- Study startDec 1994
- Primary completionAug 2015
- Study completionAug 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies of the same condition, open and under way.
- More trials run by City of Hope Medical 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
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- City of Hope Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- George Somlo, MD, Study chair, City of Hope Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00002854
- Sponsor's protocol ID
- 94098
- Other IDs
- P30CA033572, CHNMC-IRB-94098, NCI-V96-1042, CDR0000065102
- Status last verified
- Aug 2015
- First submitted
- 1 Nov 1999
- Last updated
- 26 Aug 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PHASE I PILOT STUDY OF SEQUENTIAL HIGH DOSE CYCLES OF CISPLATIN, CYCLOPHOSPHAMIDE, ETOPOSIDE AND IFOSFAMIDE, CARBOPLATIN AND TAXOL WITH AUTOLOGOUS STEM CELL SUPPORT
- ClinicalTrials.gov ID
- NCT00002854
- Acronym / sponsor ID
- 94098
- Conditions
- Cancer
- Keywords
- stage IV colon cancer, stage II breast cancer, stage IV breast cancer, stage IIIA breast cancer, recurrent breast cancer, stage IV gastric cancer, recurrent gastric cancer, localized osteosarcoma
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- City of Hope Medical CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Dec 1994
- Primary completion
- Aug 2015 (actual)
- Study completion
- Aug 2015 (actual)
- First posted
- 27 Jan 2003 (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 tumor cells from dividing so they stop growing or die. Peripheral stem cell transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more tumor cells.
PURPOSE: Phase I trial to study the effectiveness of combination chemotherapy plus peripheral stem cell transplantation in treating patients who have advanced cancer.
Detailed description
OBJECTIVES:
- Evaluate the feasibility of administering 2 courses of high dose chemotherapy consisting of etoposide, cisplatin, and cyclophosphamide followed by ifosfamide, carboplatin, and paclitaxel (IC-T), each administered with filgrastim (G-CSF) and autologous stem cell support, to patients with advanced carcinomas.
- Describe the toxicity of these high dose chemotherapy regimens.
- Define the maximum tolerated dose of paclitaxel deliverable in this high dose regimen.
- Describe the pharmacokinetics of escalating doses of paclitaxel given as a 24-hour continuous infusion.
- Determine the disposition of carboplatin administered in the IC-T regimen.
OUTLINE: At least 4 weeks prior to chemotherapy, patients undergo stem cell collection following filgrastim (G-CSF) mobilization. Sufficient stem cells to support 2 courses of chemotherapy are required. Autologous bone marrow is collected as an adjuvant if stem cell harvest is inadequate.
Patients then receive high dose cisplatin, etoposide, and cyclophosphamide over 10 days, followed the next day by infusion of one fourth of the allotted stem cells, with the remaining allotment infused 2 days later. G-CSF is given for granulocyte support.
Beginning no sooner than 14 weeks from the start of the first course of chemotherapy, stable and responding patients receive high dose paclitaxel, carboplatin, and ifosfamide over 5 days, followed 2 days later with one-fourth of the allotted stem cells, with the remaining allotment infused the following day. G-CSF is given for granulocyte support. Groups of 3-6 patients are treated with escalating doses of paclitaxel until the maximum tolerated dose for this regimen is determined.
Patients are followed monthly for 1 year, every 3 months for 1 year, then as needed at the physician's discretion for at least 5 years.
PROJECTED ACCRUAL: Three to six patients will be entered at each dose of paclitaxel studied.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Sequential high dose chemotherapy | Experimental | Biological: filgrastim, Drug: carboplatin, Drug: cisplatin, Drug: cyclophosphamide, Drug: etoposide, Drug: ifosfamide, Drug: mesna, Drug: paclitaxel, Procedure: peripheral blood stem cell transplantation |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- 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 | Sequential high dose chemotherapy |
| carboplatin | Drug | Sequential high dose chemotherapy |
| cisplatin | Drug | Sequential high dose chemotherapy |
| cyclophosphamide | Drug | Sequential high dose chemotherapy |
| etoposide | Drug | Sequential high dose chemotherapy |
| ifosfamide | Drug | Sequential high dose chemotherapy |
| mesna | Drug | Sequential high dose chemotherapy |
| paclitaxel | Drug | Sequential high dose chemotherapy |
| peripheral blood stem cell transplantation | Procedure or surgery | Sequential high dose chemotherapy |
Primary outcome
Feasibility of two cycles of high dose chemotherapy with stem cell reinfusion
Time frame: 30 days from start of course II of treatment
Toxicity of two cycles of high dose chemothearpy and stem cell reinfusion
Time frame: 30 days from start of course II of treatment
Toxicity graded according to the NCI Common Toxicity Criteria and amended for subjects undergoing transplantation
Maximum tolerated dose of two cycles of high dose chemothearpy and stem cell reinfusion
Time frame: 30 days from start of course II of treatment
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 26 Aug 2015.
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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.
George Somlo, MD study chair
City of Hope Medical 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 cisplatin in people with Cancer, run by City of Hope Medical 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 26 Aug 2015. 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.
What does the primary outcome measure?
Feasibility of two cycles of high dose chemotherapy with stem cell reinfusion (time frame: 30 days from start of course II of treatment). The study lists 3 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 26 Aug 2015.