Neoplasms, Unknown PrimaryPhase 3NCT00193596
Gemcitabine/Irinotecan/ZD1839 vs Paclitaxel/Carboplatin/Etoposide/ZD1839 in Carcinoma of Unknown Primary Site
A Phase 3 study testing Etoposide, Gemcitabine and Irinotecan in people with Neoplasms, Unknown Primary, run by SCRI Development Innovations, LLC at 31 sites in United States.
Trial summary
In this randomized trial, we will investigate the activity and toxicity of two active regimens, gemcitabine/irinotecan and paclitaxel/carboplatin/Etoposide (both followed by ZD1839) in the first-line treatment of patients with carcinoma of unknown primary site. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Neoplasms, Unknown Primary
- What is being tested?
- Etoposide, Gemcitabine 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
- 198 participants
- Where
- 31 sitesUnited States
- Study dates
- Sep 2003to Jun 2009
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- To be included in this study, you must meet the following criteria:
- Carcinoma of unknown primary site
- Biopsy-proven metastatic carcinoma
- Able to perform activities of daily living with minimal assistance
- No previous treatment with any systemic therapy
- Measurable or evaluable disease
- Adequate bone marrow, liver and kidney function
- Understand the nature of this study and give written informed consent
Who cannot join
- You cannot participate in this study if any of the following apply to you:
- Age < 18 years
- Uncontrolled brain metastases and meningeal involvement
- Other uncontrolled malignancies
- Women pregnant or lactating
- Recent history of significant cardiovascular disease
Show all 10Show fewer
- Severe or uncontrolled systemic disease
- Other significant clinical disorder
- Clinically active interstitial lung disease
- Please note: There are additional inclusion/exclusion criteria. The study center will determine if you meet all of the criteria. If you do not qualify for the trial, study personnel will explain the reasons. If you do qualify, study personnel will explain the trial in detail and answer any questions you may have.
Trial locations and contacts
31 sites in 1 country.
31 sites in 1 country
United States31 sites
Cancer Outreach Associates
Abingdon, Virginia, 24211
Phoebe Cancer Center
Albany, Georgia, 31701
Northeast Alabama Regional Medical Center
Anniston, Alabama, 36207
Tower Oncology
Beverly Hills, California, 90211
Graves-Gilbert Clinic
Bowling Green, Kentucky, 42101
Aultman Hospital
Canton, Ohio, 44710
Oncology Hematology Care
Cincinnati, Ohio, 45242
Consultants in Medical Oncology and Hematology
Drexel Hill, Pennsylvania, 19026
Oncology Hematology Associates of SW Indiana
Evansville, Indiana, 47714
Northeast Georgia Medical Center
Gainesville, Georgia, 30501
Grand Rapids Clinical Oncology Program
Grand Rapids, Michigan, 49503
Terrebonne General Medical Center
Houma, Louisiana, 70360
Clearview Cancer Institute
Huntsville, Alabama, 35805
Jackson Oncology Associates
Jackson, Mississippi, 39202
Northeast Arkansas Clinic
Jonesboro, Arkansas, 72401
Kingsport Hematology-Oncology
Kingsport, Tennessee, 37660
Thompson Cancer Survival Center
Knoxville, Tennessee, 37916
Watson Clinic Center for Cancer Care and Research
Lakeland, Florida, 33805
Consultants in Blood Disorders and Cancer
Louisville, Kentucky, 40207
Wellstar Cancer Research
Marietta, Georgia, 30060
Mercy Hospital Miami
Miami, Florida, 33133
Montana Cancer Institute Foundation
Missoula, Montana, 59802
Southern Cancer Center, Sacred Heart Heath System Medical Oncology Group
Mobile, Alabama, 36608
Tennessee Oncology, PLLC
Nashville, Tennessee, 37023
Methodist Cancer Center
Omaha, Nebraska, 68114
Florida Hospital Cancer Institute
Orlando, Florida, 32804
St. Joseph Mercy Oakland Hospital, Cancer Center
Pontiac, Michigan, 48341
Mercy Hospital
Portland, Maine, 04101
South Texas Oncology and Hematology
San Antonio, Texas, 78258
Spartanburg Regional Medical Center
Spartanburg, South Carolina, 29303
Reading Hospital Regional Cancer Center
West Reading, Pennsylvania, 19612
About this study
Official title: A Randomized, Phase III Comparison of Gemcitabine/Irinotecan Followed by IRESSA Versus Paclitaxel/Carboplatin/Etoposide Followed by IRESSA in the First-Line Treatment of Patients With Carcinoma of Unknown Primary Site
In this randomized trial, we will investigate the activity and toxicity of two active regimens, gemcitabine/irinotecan and paclitaxel/carboplatin/Etoposide (both followed by ZD1839) in the first-line treatment of patients with carcinoma of unknown primary site.
Read the detailed description
Upon determination of eligibility, all patients will be randomly assigned to one of two treatment arms:
- Paclitaxel + Carboplatin + Etoposide
- Irinotecan + Gemcitabine
Patients will be stratified by tumor location (liver/bone versus all others) and number of metastatic sites (one versus two or more). Patients with an objective response or stable disease after completion of chemotherapy will receive ZD1839 until disease progression. Patients who do not respond to chemotherapy may crossover to the other chemotherapy regimen and will receive ZD1839 if they have an objective response or stable disease. The study is not blinded so both the patient and the doctor will know which treatment has been assigned.
- Conditions
- Neoplasms, Unknown Primary
- Being tested
- Etoposide, Gemcitabine, Irinotecan, Paclitaxel, Carboplatin
- Keywords
- Neoplasms, Unknown Primary
- 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.
EtoposideDrug
Also called Etopophos, Toposar
50 mg alternating with 100 mg PO, days 1 and 10 in regimen A
GemcitabineDrug
Also called Gemzar
1000 mg/m2 IV, days 1 and 8, in regimen B
IrinotecanDrug
Also called Camptosar
1000 mg/m2 IV days 1 and 8 in regimen B
PaclitaxelDrug
Also called Abraxane
200 mg/m2 by 1-hour IV infusion, day 1, regimen A
CarboplatinDrug
Also called Paraplatin
Area under the curve (AUC) 6.0 IV, day 1, regimen A
| Study group | Role | What they receive |
|---|---|---|
| Regimen A | Experimental | Paclitaxel 200 mg/m2 by 1-hour IV infusion, day 1
Carboplatin area under the curve (AUC) 6.0 IV, day 1
Etoposide 50 mg alternating with 100 mg by mouth, days 1 and 10
Regimen A was repeated at a 21-day interval Receives: Drug: Etoposide; Drug: Paclitaxel; Drug: Carboplatin |
| Regimen B | Experimental | Irinotecan 100 mg/m2 IV, days 1 and 8
Gemcitabine 1000 mg/m2 IV, days 1 and 8
Regimen B was repeated at a 21-day interval Receives: Drug: Gemcitabine; Drug: Irinotecan |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Survival (OS), the Length of Time, in Months, That Patients Were Alive From Their First Date of Protocol Treatment Until Death
Length of time, in months, that patients were alive from their first date of protocol treatment until death.
Measured: 24 months
Secondary outcomes (1)
Progression Free Survival (PFS), the Length of Time, in Months, That Patients Were Alive From Their First Date of Protocol Treatment Until Worsening of Their Disease
Length of time, in months, that patients were alive from their first date of protocol treatment until worsening of their disease
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2005 (estimated)
- Study startSep 2003
- Primary completionSep 2008
- Study completionJun 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Neoplasms, Unknown PrimaryStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 198 participants (actual)
Sponsor and investigators
- Lead sponsor
- SCRI Development Innovations, LLC
- Sponsor type
- University, hospital or other
- Collaborators
- AstraZeneca, Pharmacia and Upjohn, Eli Lilly and Company
- Responsible party
- Sponsor
- Investigators
- John D. Hainsworth, MD, Principal investigator, SCRI Development Innovations, LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00193596
- Sponsor's protocol ID
- SCRI UNKPRI 12
- Status last verified
- Mar 2013
- First submitted
- 12 Sep 2005
- Last updated
- 3 May 2013
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Hainsworth JD, Spigel DR, Clark BL, Shipley D, Thompson DS, Farley C, West-Osterfield K, Lane CM, Cescon T, Bury MJ, Greco FA. Paclitaxel/carboplatin/etoposide versus gemcitabine/irinotecan in the first-line treatment of patients with carcinoma of unknown primary site: a randomized, phase III Sarah Cannon Oncology Research Consortium Trial. Cancer J. 2010 Jan-Feb;16(1):70-5. doi: 10.1097/PPO.0b013e3181c6aa89.
PubMed 20164695
Study at a glance
From the registry record, last updated by the sponsor on 3 May 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Phase III Comparison of Gemcitabine/Irinotecan Followed by IRESSA Versus Paclitaxel/Carboplatin/Etoposide Followed by IRESSA in the First-Line Treatment of Patients With Carcinoma of Unknown Primary Site
- ClinicalTrials.gov ID
- NCT00193596
- Acronym / sponsor ID
- SCRI UNKPRI 12
- Conditions
- Neoplasms, Unknown Primary
- Keywords
- Neoplasms, Unknown Primary
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 198 participants (actual)
- Lead sponsor
- SCRI Development Innovations, LLCUniversity, hospital or other
- Collaborators
- AstraZeneca, Pharmacia and Upjohn, Eli Lilly and Company
- Study start
- Sep 2003
- Primary completion
- Sep 2008 (actual)
- Study completion
- Jun 2009 (actual)
- First posted
- 19 Sep 2005 (estimated)
- Results
- Posted 3 May 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
In this randomized trial, we will investigate the activity and toxicity of two active regimens, gemcitabine/irinotecan and paclitaxel/carboplatin/Etoposide (both followed by ZD1839) in the first-line treatment of patients with carcinoma of unknown primary site.
Detailed description
Upon determination of eligibility, all patients will be randomly assigned to one of two treatment arms:
- Paclitaxel + Carboplatin + Etoposide
- Irinotecan + Gemcitabine
Patients will be stratified by tumor location (liver/bone versus all others) and number of metastatic sites (one versus two or more). Patients with an objective response or stable disease after completion of chemotherapy will receive ZD1839 until disease progression. Patients who do not respond to chemotherapy may crossover to the other chemotherapy regimen and will receive ZD1839 if they have an objective response or stable disease. The study is not blinded so both the patient and the doctor will know which treatment has been assigned.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Regimen A | Experimental | Drug: Etoposide, Drug: Paclitaxel, Drug: CarboplatinPaclitaxel 200 mg/m2 by 1-hour IV infusion, day 1 Carboplatin area under the curve (AUC) 6.0 IV, day 1 Etoposide 50 mg alternating with 100 mg by mouth, days 1 and 10 Regimen A was repeated at a 21-day interval |
| Regimen B | Experimental | Drug: Gemcitabine, Drug: IrinotecanIrinotecan 100 mg/m2 IV, days 1 and 8 Gemcitabine 1000 mg/m2 IV, days 1 and 8 Regimen B was repeated at a 21-day interval |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Carcinoma of unknown primary site
- Biopsy-proven metastatic carcinoma
- Able to perform activities of daily living with minimal assistance
- No previous treatment with any systemic therapy
- Measurable or evaluable disease
Key exclusion criteria (10 listed)
- Age < 18 years
- Uncontrolled brain metastases and meningeal involvement
- Other uncontrolled malignancies
- Women pregnant or lactating
- Recent history of significant cardiovascular disease
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 |
|---|---|---|
| EtoposideAlso: Etopophos, Toposar50 mg alternating with 100 mg PO, days 1 and 10 in regimen A | Drug | Regimen A |
| GemcitabineAlso: Gemzar1000 mg/m2 IV, days 1 and 8, in regimen B | Drug | Regimen B |
| IrinotecanAlso: Camptosar1000 mg/m2 IV days 1 and 8 in regimen B | Drug | Regimen B |
| PaclitaxelAlso: Abraxane200 mg/m2 by 1-hour IV infusion, day 1, regimen A | Drug | Regimen A |
| CarboplatinAlso: ParaplatinArea under the curve (AUC) 6.0 IV, day 1, regimen A | Drug | Regimen A |
Primary outcome
Overall Survival (OS), the Length of Time, in Months, That Patients Were Alive From Their First Date of Protocol Treatment Until Death
Time frame: 24 months
Length of time, in months, that patients were alive from their first date of protocol treatment until death.
1 secondary outcome
Progression Free Survival (PFS), the Length of Time, in Months, That Patients Were Alive From Their First Date of Protocol Treatment Until Worsening of Their Disease
Time frame: 12 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 May 2013.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 20164695Hainsworth JD, Spigel DR, Clark BL, Shipley D, Thompson DS, Farley C, West-Osterfield K, Lane CM, Cescon T, Bury MJ, Greco FA. Paclitaxel/carboplatin/etoposide versus gemcitabine/irinotecan in the first-line treatment of patients with carcinoma of unknown primary site: a randomized, phase III Sarah Cannon Oncology Research Consortium Trial. Cancer J. 2010 Jan-Feb;16(1):70-5. doi: 10.1097/PPO.0b013e3181c6aa89.
- Published article in The Cancer JournalLink provided by the sponsor.
Related trials for Neoplasms, Unknown Primary
Active, not recruitingPhase 1
Prospective Exploratory Study of FAPi PET/CT With Histopathology Validation in Patients With Various Cancers
Bladder Carcinoma, Cervical Carcinoma
RecruitingPhase 3
Testing the Addition of Anti-Cancer Drug, Cetuximab, to Standard of Care Treatment (Pembrolizumab) for Returning or Spreading Head and Neck Cancer After Previous Treatment
Metastatic Head and Neck Squamous Cell Carcinoma, Metastatic Hypopharyngeal Squamous Cell Carcinoma
Recruiting
Studying the PAGODA Algorithm for Chemotherapy Dose Changes to Prevent Unplanned Treatment Delays
Ampulla of Vater Carcinoma, Appendix Carcinoma
RecruitingObservational study
Rare Disease Patient Registry & Natural History Study - Coordination of Rare Diseases at Sanford
Rare Disorders, Undiagnosed Disorders
Not yet recruiting
Smartphone-Based Self-Registration of Health Data in Patients With Severe Unspecific Symptoms or Cancer of Unknown Primary
Advanced Unspecific Symptom, Cancer of Unknown Primary Site
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.
John D. Hainsworth, MD principal investigator
SCRI Development Innovations, LLC
31 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Etoposide, Gemcitabine and Irinotecan in people with Neoplasms, Unknown Primary, run by SCRI Development Innovations, LLC at 31 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 8 inclusion and 10 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 3 May 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 31 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 3 May 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Overall Survival (OS), the Length of Time, in Months, That Patients Were Alive From Their First Date of Protocol Treatment Until Death (time frame: 24 months). 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 NCT00193596, 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 3 May 2013.