Paclitaxel/Carboplatin With or Without Cetuximab in CUP

NCT00894569 | Unknown Phase 2 DMC

• 1 other identifier: EUDRACT 2008-003174-18
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Neoplasms, Unknown Primary; Carcinoma

Keywords

carcinoma of unknown primary; cancer of unknown primary; CUP; carboplatin; paclitaxel; cetuximab

Outcome Measures

Primary Outcomes (1)

• 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.

  8 months after randomization

Secondary Outcomes (1)

• Efficacy: Response rate, Median progression free survival (PFS), Overall survival (OS) Toxicity

  until end of study

Study Arms (2)

A

ACTIVE COMPARATOR

6 cycles of carboplatin/paclitaxel

Drug: paclitaxel/carboplatin

B

EXPERIMENTAL

carboplatin/paclitaxel plus cetuximab until disease progression

Drug: paclitaxel/carboplatin; Drug: cetuximab

Interventions

paclitaxel/carboplatin DRUG

6 cycles paclitaxel 175 mg/m² and carboplatin AUC 5, repetition d22.

A; B

cetuximab DRUG

cetuximab (400 mg/m² first dose, 250 mg/m² weekly) until disease progression

B

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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

You may not qualify if:

• 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
• 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
• 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

Sponsors & Collaborators

• Heidelberg University: lead
• Merck KGaA, Darmstadt, Germany: collaborator

Study Sites (1)

University Hospital Heidelberg, Med. Dep. v

Heidelberg, 69120, Germany

Location

Related Publications (1)

• 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.

  PMID: 33235314 DERIVED

MeSH Terms

Conditions

Neoplasms, Unknown Primary; Carcinoma

Interventions

CP protocol; Cetuximab

Condition Hierarchy (Ancestors)

Neoplasm Metastasis; Neoplastic Processes; Neoplasms; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Alwin Kraemer, Prof. Dr.

  University of Heidelberg, Medic. Dep. V

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Alwin Kraemer, Prof.

CONTACT

+49-6221-42-1441; a.kraemer@dkfz.de

Katharina Schuette, Dr.

CONTACT

+49-351-458-2311; katharina.schuette@uniklinikum-dresden.de

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: May 6, 2009
• First Posted: May 7, 2009
• Study Start: July 1, 2009
• Primary Completion: July 1, 2010
• Study Completion: August 1, 2011
• Last Updated: May 14, 2009

Record last verified: 2009-05

Locations

DE (1)