Nimotuzumab in Adults With Pancreatic Cancer

NCT00561990 | Completed Phase 2 DMC

• 1 other identifier: OSAG101-PCS07
• Study Type: interventional
• Target: 188
• Locations: 1 country
• Sites: 1

Brief Summary

CHEMOTHERAPY-NAIVE PATIENTS WITH LOCALLY ADVANCED OR METASTATIC PANCREATIC CANCER

Conditions

Pancreatic Cancer, Advanced or Metastatic

Keywords

pancreatic cancer

Outcome Measures

Primary Outcomes (1)

• Time to tumor progression (TTP) and overall survival (OS) in chemotherapy-naive patients. To assess the efficacy of Nimotuzumab as add on therapy to Gemcitabine in comparison with Gemcitabine and placebo

  Week 8, 12

Secondary Outcomes (1)

• To evaluate the objective tumor response (overall response rate [ORR]) and duration of response (DR) To evaluate the safety profile of Nimotuzumab in combination with Gemcitabine To evaluate quality of life (QoL) according to EORTC

  Week 8, 16

Study Arms (2)

Nimotuzumab

ACTIVE COMPARATOR

Nimotuzumab

Drug: Nimotuzumab

Placebo

PLACEBO COMPARATOR

Placebo

Drug: Nimotuzumab

Interventions

Nimotuzumab DRUG

Nimotuzumab; Placebo

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• written informed consent.
• histologically or cytologically confirmed locally advanced or metastatic adenocarcinoma of the pancreas not amenable to curative radiotherapy or surgery.
• measurable disease as defined by Response Evaluation Criteria in Solid Tumors (RECIST) criteria (ie, target lesions that can be accurately measured in at least one dimension with the longest diameter ≥ 20 mm using conventional techniques or ≥ 10 mm using spiral computed tomography \[CT\] scan).
• able to take medications orally.
• at least18 years of age or older.
• Karnofsky Performance Status (KPS) ≥ 70% (see Appendix A).
• life expectancy of \> 12 weeks.
• adequate organ function as defined by the following criteria:
• Transaminases AST (SGOT) and ALT (SGPT) ≤ 2.5 times the upper limit of normal (ULN).
• If liver function abnormalities are due to underlying liver metastasis, then AST (SGOT) and ALT (SGPT) may be ≤ 5 times ULN.
• Total serum bilirubin ≤ 3.0 times ULN (if due to underlying liver metastasis, then total bilirubin may be ≤ 5 times ULN).
• Absolute granulocyte count ≥ 1,500/mm3 (ie, ≥ 1.5 x 109/L by International Units (IU\]).
• Platelet count ≥ 100,000/mm3 (IU: ≥ 100 x 109/L).
• Hemoglobin value ≥ 9.0 g/dL.
• Calculated creatinine clearance ≥ 60 mL/min (based on serum creatinine) (Cockcroft Gault formula).

You may not qualify if:

• had treatment with any of the following within the specified time frame prior to study drug administration:
• Any prior anticancer chemotherapy.
• Radiation therapy to a target lesion unless there was evidence of PD after radiotherapy (and this target lesion must not be the only site of measurable disease).
• Any radiotherapy within the previous 3 weeks.
• Any investigational agent received either concurrently or within the last 30 days.
• Current enrollment in another clinical trial.
• Major surgery within the previous 3 weeks.
• Symptomatic brain metastasis not controlled by corticosteroids.
• Leptomeningeal metastasis.
• Previous or concurrent malignancy other than pancreatic cancer except adequately treated carcinoma in-situ of the cervix or non-melanoma skin cancer.
• Uncontrolled ascites requiring drainage at least twice a week.
• Other serious illness or medical condition(s) including, but not limited to, the following:
• Uncontrolled congestive heart failure (New York Heart Association \[NYHA\]
• Class III or IV, see Appendix F), angina pectoris, arrhythmias, or hypertension.
• active infection.

Sponsors & Collaborators

• Oncoscience AG: lead
• Marienhospital Herne: collaborator
• University of Kiel: collaborator
• Gemeinschaftspraxis für Hämatologie und Onkologie, Köln, Germany: collaborator
• Onkologisches Zentrum III, Medizinische Klinik, Mannheim, Germany: collaborator
• Onkologische Gemeinschaftspraxis, Mülheim, Germany: collaborator
• II. Medizinische Klinik u. Poliklinik, Klinikum rechts der Isar, München, Germany: collaborator
• Hämatologisch-Onkologische Schwerpunktpraxis, Münster, Germany: collaborator
• Praxis für Internistische Onkologie und Hämatologie, Recklinghausen, Germany: collaborator

Study Sites (1)

Marienhospital Herne

Herne, 44621, Germany

Location

Related Publications (1)

• Schultheis B, Reuter D, Ebert MP, Siveke J, Kerkhoff A, Berdel WE, Hofheinz R, Behringer DM, Schmidt WE, Goker E, De Dosso S, Kneba M, Yalcin S, Overkamp F, Schlegel F, Dommach M, Rohrberg R, Steinmetz T, Bulitta M, Strumberg D. Gemcitabine combined with the monoclonal antibody nimotuzumab is an active first-line regimen in KRAS wildtype patients with locally advanced or metastatic pancreatic cancer: a multicenter, randomized phase IIb study. Ann Oncol. 2017 Oct 1;28(10):2429-2435. doi: 10.1093/annonc/mdx343.

  PMID: 28961832 DERIVED

MeSH Terms

Conditions

Pancreatic Neoplasms; Neoplasm Metastasis

Interventions

nimotuzumab

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Dirk Strumberg, MD

  University Bochum

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 20, 2007
• First Posted: November 21, 2007
• Study Start: September 1, 2007
• Primary Completion: January 1, 2013
• Study Completion: January 1, 2014
• Last Updated: October 15, 2015

Record last verified: 2015-10

Locations

DE (1)