Neoplasms, Unknown PrimaryPhase 2PACET-CUPNCT00894569
Paclitaxel/Carboplatin With or Without Cetuximab in CUP
A Phase 2 study testing paclitaxel/carboplatin and cetuximab in people with Neoplasms, Unknown Primary and Carcinoma, run by Heidelberg University at 1 site in Germany.
Trial summary
The purpose of this study is to determine whether an addition of cetuximab to carboplatin/paclitaxel can improve efficacy in comparison to carboplatin/paclitaxel in patients with carcinoma of unknown-primary. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Neoplasms, Unknown Primary, Carcinoma
- What is being tested?
- paclitaxel/carboplatin and cetuximab
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteGermany
- Study dates
- Jul 2009to Aug 2011
- 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
- Histologic or cytologic proven, non-resectable carcinoma of unknown primary (adenocarcinoma or non-differentiated carcinoma)
- Measurable tumor lesion(s) according to RECIST criteria
- WHO PS 0 to 1
- Paclitaxel/Carboplatin with or without Cetuximab in Adeno- and Undifferentiated CUP (PACET-CUP)
- Signed written informed consent
- ≥ 18 years of age
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- Effective contraception for both male and female subjects if the risk of conception exists
- Adequate bone marrow function:
- Neutrophiles blood cell count (NBC) ≥ 1,5x109/L
- Platelet count ≥ 100x109/L
- Hemoglobin ≥ 5,00 mmol/L (8 g/dL)
- Adequate liver and renal function:
- Bilirubin ≤ 1,5 x upper normal level (UNL) and not increasing more than 25% within the last 4 weeks
- ASAT and ALAT ≤ 2,5 x UNL or in case of liver metastases ≤ 5 x UNL
- Serum creatinine ≤ 1.5 x UNL
Who cannot join
- Previous exposure to epidermal growth factor receptor-targeting therapy
- Previous chemotherapy except adjuvant treatment with progression of disease documented > 6 months after end of adjuvant treatment
- Radiotherapy or major abdominal or thoracic surgery within the last 4 weeks before inclusion
- Concurrent chronic systemic immunotherapy, chemotherapy or hormone therapy
- Investigational agents or participation in clinical trials within 30 days before treatment start in this study
- Clinically relevant coronary disease or myocardial infarction within 12 months before study entry
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- Possibility of a curative local treatment (surgery and/or radiotherapy)
- Women with axillary node metastasis as predominant tumor site
- Women with peritoneal carcinomatosis as predominant tumor site
- Men < 50 years old with retroperitoneal or mediastinal lymph node +/- lung metastases as predominant tumor site
- Identification of the primary or suspicion of a specific tumor entity by reference histopathology (i.e., Her-2 positive or hormone receptor positive tumors corresponding to breast cancer, CK7-negative/CK20- positive tumors with high probability for colorectal cancer)
- Peripheral neuropathy > CTC grade I
- Previous malignancy within the last 5 years (except history of basal cell carcinoma of skin or pre-invasive carcinoma of the cervix with adequate treatment)
- History of severe psychiatric illness
- Life expectancy less than six weeks
- Drug or alcohol abuse
- Known hypersensitivity reaction to any of the components of the study treatment
- Pregnancy (absence to be confirmed by β-hCG test) or lactation period
- Brain metastasis and/or leptomeningeal disease (known or suspected)
- Acute or sub-acute intestinal occlusion or inflammatory bowel disease
Trial locations and contacts
1 site in 1 country.
Germany1 site
University Hospital Heidelberg, Med. Dep. v
Heidelberg, 69120
Kraemer, +49-6221-42-1441, a.kraemer@dkfz.de
Alwin Kraemer, Prof. Dr.
About this study
Official title: Open-Labeled, Randomized Multi-Center Phase II Study Evaluating the Efficacy and Safety of Paclitaxel/ Carboplatin With and Without Cetuximab as First-Line Treatment of Adeno- and Undifferentiated Carcinoma of Unknown Primary (CUP)
The purpose of this study is to determine whether an addition of cetuximab to carboplatin/paclitaxel can improve efficacy in comparison to carboplatin/paclitaxel in patients with carcinoma of unknown-primary.
Read the detailed description
Carcinomas of unknown primary (CUP) account for approximately 2-5% of all cancer diagnoses. Except for some subsets with favorable prognosis, for most of these patients, treatment options are limited, and no standard first-line regimen has been identified. Standard therapy for patients with adeno- or undifferentiated CUP is Paclitaxel/Carboplatin, yielding response rates between 20-40%. In recent years, targeted therapies with inhibitors to EGFR, several tyrosine kinases, and VEGF have been shown to improve survival in different solid tumor entities. Cetuximab, a monoclonal antibody against the EGF receptor, has proved efficacy in combination with chemotherapy in patients with metastatic colorectal cancer, gastric cancer, squamous cell carcinoma of head and neck and non-small cell lung cancer (NSCLC). Because of these promising results it seems to be reasonable to examine the impact of adding cetuximab to standard chemotherapy with paclitaxel and carboplatin in patients with CUP.
- Conditions
- Neoplasms, Unknown Primary, Carcinoma
- Being tested
- paclitaxel/carboplatin, cetuximab
- Keywords
- carcinoma of unknown primary, cancer of unknown primary, CUP, carboplatin, paclitaxel, cetuximab
- Medical subject headings
- Neoplasms, Unknown Primary, Carcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
paclitaxel/carboplatinDrug
6 cycles paclitaxel 175 mg/m² and carboplatin AUC 5, repetition d22.
cetuximabDrug
cetuximab (400 mg/m² first dose, 250 mg/m² weekly) until disease progression
| Study group | Role | What they receive |
|---|---|---|
| A | Active comparator | 6 cycles of carboplatin/paclitaxel Receives: Drug: paclitaxel/carboplatin |
| B | Experimental | carboplatin/paclitaxel plus cetuximab until disease progression Receives: Drug: paclitaxel/carboplatin; Drug: cetuximab |
What is being measured
The primary outcome is the main question the study is designed to answer.
The rate of progression free survival at 8 months after randomization, defined as the proportion of patients alive with stable disease, partial or complete response, according to RECIST is the primary endpoint for the final analysis.
Measured: 8 months after randomization
Secondary outcomes (1)
Efficacy: Response rate, Median progression free survival (PFS), Overall survival (OS) Toxicity
Measured: until end of study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2009 (estimated)
- Study startJul 2009
- Primary completionJul 2010 (estimated)
- Study completionAug 2011 (estimated)
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 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Heidelberg University
- Sponsor type
- University, hospital or other
- Collaborators
- Merck KGaA, Darmstadt, Germany
- Investigators
- Alwin Kraemer, Prof. Dr., Principal investigator, University of Heidelberg, Medic. Dep. V
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00894569
- Sponsor's protocol ID
- EUDRACT 2008-003174-18
- Acronym
- PACET-CUP
- Status last verified
- May 2009
- First submitted
- 6 May 2009
- Last updated
- 14 May 2009
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Folprecht G, Trautmann K, Stein A, Huebner G, Stahl M, Kasper S, Kretzschmar A, Kohne CH, Grunwald V, Hofheinz RD, Schutte K, Loffler H, Bokemeyer C, Kramer A; Arbeitsgemeinschaft Internistische Onkologie (AIO) - CUP Group. Adding cetuximab to paclitaxel and carboplatin for first-line treatment of carcinoma of unknown primary (CUP): results of the Phase 2 AIO trial PACET-CUP. Br J Cancer. 2021 Feb;124(4):721-727. doi: 10.1038/s41416-020-01141-8. Epub 2020 Nov 25.
PubMed 33235314
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open-Labeled, Randomized Multi-Center Phase II Study Evaluating the Efficacy and Safety of Paclitaxel/ Carboplatin With and Without Cetuximab as First-Line Treatment of Adeno- and Undifferentiated Carcinoma of Unknown Primary (CUP)
- ClinicalTrials.gov ID
- NCT00894569
- Acronym / sponsor ID
- PACET-CUP / EUDRACT 2008-003174-18
- Conditions
- Neoplasms, Unknown Primary, Carcinoma
- Keywords
- carcinoma of unknown primary, cancer of unknown primary, CUP, carboplatin, paclitaxel, cetuximab
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Heidelberg UniversityUniversity, hospital or other
- Collaborators
- Merck KGaA, Darmstadt, Germany
- Study start
- Jul 2009
- Primary completion
- Jul 2010 (estimated)
- Study completion
- Aug 2011 (estimated)
- First posted
- 7 May 2009 (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 determine whether an addition of cetuximab to carboplatin/paclitaxel can improve efficacy in comparison to carboplatin/paclitaxel in patients with carcinoma of unknown-primary.
Detailed description
Carcinomas of unknown primary (CUP) account for approximately 2-5% of all cancer diagnoses. Except for some subsets with favorable prognosis, for most of these patients, treatment options are limited, and no standard first-line regimen has been identified. Standard therapy for patients with adeno- or undifferentiated CUP is Paclitaxel/Carboplatin, yielding response rates between 20-40%. In recent years, targeted therapies with inhibitors to EGFR, several tyrosine kinases, and VEGF have been shown to improve survival in different solid tumor entities. Cetuximab, a monoclonal antibody against the EGF receptor, has proved efficacy in combination with chemotherapy in patients with metastatic colorectal cancer, gastric cancer, squamous cell carcinoma of head and neck and non-small cell lung cancer (NSCLC). Because of these promising results it seems to be reasonable to examine the impact of adding cetuximab to standard chemotherapy with paclitaxel and carboplatin in patients with CUP.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A | Active comparator | Drug: paclitaxel/carboplatin6 cycles of carboplatin/paclitaxel |
| B | Experimental | Drug: paclitaxel/carboplatin, Drug: cetuximabcarboplatin/paclitaxel plus cetuximab until disease progression |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- Histologic or cytologic proven, non-resectable carcinoma of unknown primary (adenocarcinoma or non-differentiated carcinoma)
- Measurable tumor lesion(s) according to RECIST criteria
- WHO PS 0 to 1
- Paclitaxel/Carboplatin with or without Cetuximab in Adeno- and Undifferentiated CUP (PACET-CUP)
- Signed written informed consent
Key exclusion criteria (20 listed)
- Previous exposure to epidermal growth factor receptor-targeting therapy
- Previous chemotherapy except adjuvant treatment with progression of disease documented > 6 months after end of adjuvant treatment
- Radiotherapy or major abdominal or thoracic surgery within the last 4 weeks before inclusion
- Concurrent chronic systemic immunotherapy, chemotherapy or hormone therapy
- Investigational agents or participation in clinical trials within 30 days before treatment start in this study
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 |
|---|---|---|
| paclitaxel/carboplatin6 cycles paclitaxel 175 mg/m² and carboplatin AUC 5, repetition d22. | Drug | A, B |
| cetuximabcetuximab (400 mg/m² first dose, 250 mg/m² weekly) until disease progression | Drug | B |
Primary outcome
The rate of progression free survival at 8 months after randomization, defined as the proportion of patients alive with stable disease, partial or complete response, according to RECIST is the primary endpoint for the final analysis.
Time frame: 8 months after randomization
1 secondary outcome
Efficacy: Response rate, Median progression free survival (PFS), Overall survival (OS) Toxicity
Time frame: until end of study
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2009.
- Derived from this study: PubMed 33235314Folprecht G, Trautmann K, Stein A, Huebner G, Stahl M, Kasper S, Kretzschmar A, Kohne CH, Grunwald V, Hofheinz RD, Schutte K, Loffler H, Bokemeyer C, Kramer A; Arbeitsgemeinschaft Internistische Onkologie (AIO) - CUP Group. Adding cetuximab to paclitaxel and carboplatin for first-line treatment of carcinoma of unknown primary (CUP): results of the Phase 2 AIO trial PACET-CUP. Br J Cancer. 2021 Feb;124(4):721-727. doi: 10.1038/s41416-020-01141-8. Epub 2020 Nov 25.
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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.
Alwin Kraemer, Prof. Dr. principal investigator
University of Heidelberg, Medic. Dep. V
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 paclitaxel/carboplatin and cetuximab in people with Neoplasms, Unknown Primary and Carcinoma, run by Heidelberg University at 1 site in Germany.
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 15 inclusion and 20 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: status not confirmed, as of the sponsor's last update on 14 May 2009. 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 Germany. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Alwin Kraemer, Prof. (+49-6221-42-1441, a.kraemer@dkfz.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The rate of progression free survival at 8 months after randomization, defined as the proportion of patients alive with stable disease, partial or complete response, according to RECIST is the primary endpoint for the final analysis. (time frame: 8 months after randomization). 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 NCT00894569, 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 14 May 2009.