Capecitabine/Erlotinib Followed of Gemcitabine Versus Gemcitabine/Erlotinib Followed of Capecitabine

Conditions

Pancreatic Cancer

Keywords

capecitabine, gemcitabine, Erlotinib, pancreatic cancer, advanced

Brief summary

This crossover trial is performed in advanced and metastatic pancreatic cancer not previously exposed to chemotherapy. The study compares a standard arm with gemcitabine plus erlotinib to an experimental arm with capecitabine plus erlotinib. It is the first trial of its kind to incorporate second-line treatment into the study design. Patient who fail on first-line therapy are switched to the comparator chemotherapy without erlotinib. The trial therefore not only compares two different regimens of first-line treatment, it also compares two sequential treatment strategies.

Weiss L, Heinemann V, Fischer LE, Gieseler F, Hoehler T, Mayerle J, Quietzsch D, Reinacher-Schick A, Schenk M, Seipelt G, Siveke JT, Stahl M, Vehling-Kaiser U, Waldschmidt DT, Dorman K, Zhang D, Westphalen CB, von Bergwelt-Baildon M, Boeck S, Haas M.

2023-10-04

10.1007/s12094-023-03323-1

TPX2 expression as a negative predictor of gemcitabine efficacy in pancreatic cancer.

Guenther M, Surendran SA, Haas M, Heinemann V, von Bergwelt-Baildon M, Engel J, Werner J, Boeck S, Ormanns S.

2023-05-047 citations

10.1038/s41416-023-02295-x

Bacterial lipopolysaccharide as negative predictor of gemcitabine efficacy in advanced pancreatic cancer – translational results from the AIO-PK0104 Phase 3 study

Michael Guenther, Michael Haas, Volker Heinemann, Stephan Krüger, C. Benedikt Westphalen et al. (11 authors)

British Journal of Cancer2020-08-2318 citations

10.1038/s41416-020-01029-7

pERK, pAKT and p53 as tissue biomarkers in erlotinib-treated patients with advanced pancreatic cancer: a translational subgroup analysis from AIO-PK0104.

Ormanns S, Siveke JT, Heinemann V, Haas M, Sipos B, Schlitter AM, Esposito I, Jung A, Laubender RP, Kruger S, Vehling-Kaiser U, Winkelmann C, Fischer von Weikersthal L, Clemens MR, Gauler TC, Märten A, Geissler M, Greten TF, Kirchner T, Boeck S.

2014-08-2823 citations

10.1186/1471-2407-14-624

Interventions

DRUGGemcitabine

Gemcitabine 1000 mg/m², d 1, 8 , 15, q d28

DRUGCapecitabine

Capecitabine 2 x 1000 mg/m²/ d oral, d 1 - 14 followed by 7 days Pause (Flat Dosing)

DRUGErlotinib

Erlotinib 150 mg/d oral, daily without break

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

Healthy volunteers

No

Inclusion criteria

* Age between 18 and 75 years * Histologically proven pancreatic cancer stage III or IV (T1-3 N1M0 or T1 3N0 1M1) * No option for resection with curative intent * At least one measurable or not measurable lesion (according to RECIST) * No previous chemotherapy or other systemic tumor therapy * No previous radiation * Performance-Status 0-2 according to WHO/ECOG * Life expectancy of at least 3 months * Adequate kidney-, liver- and bone marrow function, defined as * Absolute neutrophil count \* 1,5 x 109/l * Hemoglobin \* 8 g/dl * Thrombocytes \* 100 x 109/l * Bilirubin \* 2 x upper norm (with liver mets \< 5-fold) * Serum Creatinine \* 1,25 x upper norm * Creatinine clearance \> 30 ml/min (Cockroft/Gault) * Transaminases \* 2,5 x upper norm (with liver mets \< 5-fold) * Possibility of regular long-term follow-up * Negative pregnancy test in women at childbearing age * All patients must have signed an informed consent before study entry.

Exclusion criteria

* Known secondary cancer other than curatively treated basalioma or carcinoma in situ of the cervix uteri * Clinically unstable CNS-metastases * Known hypersensitivity against study medication * Severe impairment of renal function (creatinine clearance \< 30 ml/min) * Severe impairment of liver function (bilirubin \> 2,0 x above upper norm, transaminases \> 2,5 x upper norm, or with known liver metastasis \>5 x upper norm) * Clinically relevant disease of the cardiovascular system or other vital organs * Known polyneuropathy * Known DPD-deficiency (screening not required) * Simultaneous treatment with the antiviral agent sorivudin or chemically related agents such as brivudin * Pregnancy, lactation or lack of reliable contraception in women at childbearing age * Mental disease, drug- or alcohol abuse * Participation in another clinical trial within the last 4 weeks * All other diseases which may prevent adequate participation in the trial * Indication of lack of compliance with study regulations

Design outcomes

Primary

Measure	Time frame	Description
TTF2	approximate 6 months after first line treatment	Time to treatment failure, after 2nd line (crossover) therapy

Secondary

Measure	Time frame	Description
Clinical Benefit Response	approximate 6 months after randomization	—
Tumor marker CA19-9 characteristics	approximate 6 months after randomization	—
Quality of Life	approximate 6 months after randomization	—
Overall Survival	42 months after randomization	—
Remission Rate	approximate 6 months after randomization	—
Toxicity	approximate 6 months after randomization	—
TTF1	approximate 6 months after randomization	Time to treatment failure

Outcome results

None listed