A Study of Tarceva (Erlotinib) in Combination With Gemcitabine in Unresectable and/or Metastatic Cancer of the Pancreas: Relationship Between Skin Toxicity and Survival

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT00461708
First received: April 17, 2007
Last updated: September 14, 2015
Last verified: September 2015
  Purpose
This single arm study will evaluate the relationship between the skin toxicity of Tarceva in combination with gemcitabine, and survival, in patients with advanced and/or metastatic pancreatic cancer. All patients will receive gemcitabine 100mg/m2 i.v. weekly; Tarceva will be administered 100mg po per day. The anticipated time on study treatment is until disease progression, and the target sample size is 100-500 individuals.

Condition Intervention Phase
Pancreatic Cancer
Drug: Erlotinib
Drug: Gemcitabine
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: An Open Label Study of Tarceva in Combination With Gemcitabine in Unresectable and/or Metastatic Cancer of the Pancreas : Relationship Between Skin Rash and Survival

Resource links provided by NLM:


Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • Number of Participants Who Died During the Study [ Time Frame: Enrollment through Cycle 24 (4-week cycles), up to 24 months. ] [ Designated as safety issue: No ]
  • Overall Survival (OS) During the Study [ Time Frame: Enrollment through Cycle 24 (4-week cycles), up to 24 months. ] [ Designated as safety issue: No ]
    OS was defined as the time, in months, from the date of enrollment to the date of death due to any cause. Participants whose last recorded status was not death were censored. OS was estimated using Kaplan-Meier methodology.


Secondary Outcome Measures:
  • Number of Participants Who Died at 6 Months [ Time Frame: Enrollment through Cycle 6 (4-week cycles), up to 6 months. ] [ Designated as safety issue: No ]
  • OS At 6 Months [ Time Frame: Enrollment through Cycle 6 (4-week cycles), up to 6 months. ] [ Designated as safety issue: No ]
    OS was defined as the time, in months, from the date of enrollment to the date of death due to any cause. Participants whose last recorded status was not death were censored. OS was estimated using Kaplan-Meier methodology.

  • Number of Participants Who Died During the Study By Rash Grade [ Time Frame: Enrollment through Cycle 24 (4-week cycles), up to 24 months. ] [ Designated as safety issue: No ]
  • OS By Rash Grade [ Time Frame: Enrollment through Cycle 24 (4-week cycles), up to 24 months. ] [ Designated as safety issue: No ]
    OS was defined as the time, in months, from the date of enrollment to the date of death due to any cause. Participants whose last recorded status was not death were censored. OS was estimated using Kaplan-Meier methodology.

  • Number of Participants With Disease Progression or Death [ Time Frame: Enrollment, every 2 treatment cycles (4-week cycles) until disease progression, death, or end of study, for up to 24 months. ] [ Designated as safety issue: No ]
    Progression-free survival (PFS) was defined as the time from the date of enrollment to the date of document disease progression or death due to any cause. As per Response Evaluation Criteria in Solid Tumors (RECIST) V 1.0, progressive disease (PD) was defined for target lesions (TLs) as at least a 20 percent (%) increase in the sum of the longest diameter (SLD), taking as reference the smallest SLD recorded since the start of treatment, and for non-target lesions (NTLs) as unequivocal progression of NTLs. Participants whose last recorded status was not PD or death were censored.

  • PFS [ Time Frame: Enrollment, every 2 treatment cycles (4-week cycles) until disease progression, death, or end of study, for up to 24 months ] [ Designated as safety issue: No ]
    The time, in months, from enrollment to PFS event. Participants whose last recorded status was not progression or death were censored. PFS was estimated using Kaplan-Meier methodology.

  • Percentage of Participants With Best Overall Response (BOR) of Complete Response (CR) or Partial Response (PR) According to RECIST [ Time Frame: Enrollment, every 2 treatment cycles (4-week cycles) until disease progression, death, or end of study, for up to 24 months. ] [ Designated as safety issue: No ]
    As per RECIST V 1.0: for TLs, a CR was defined as the disappearance of all TLs; and a PR was defined as at least a 30% decrease in the SLD of the TLs, taking as a reference the baseline (BL) SLD. For NTLs, a CR was defined as the disappearance of all NTLs and normalization of tumor marker levels. Participants for whom no assessment of response was available and who had finalized the study due to disease progression or tumor-related death, disease progression was considered the BOR.

  • Percentage of Participants With Disease Control According to RECIST [ Time Frame: Enrollment, every 2 treatment cycles (4-week cycles) until disease progression, death, or end of study, for up to 24 months. ] [ Designated as safety issue: No ]
    Disease control was defined as BOR of CR, PR, or stable disease (SD). As per RECIST V 1.0: for TLs, a CR was defined as the disappearance of all TLs; and a PR was defined as at least a 30% decrease in the SLD of the TLs, taking as a reference the BL SLD; SD was defined as neither sufficient decrease in SLD to qualify for PR nor sufficient increase in SLD to qualify for PD. For NTLs, a CR was defined as the disappearance of all NTLs and normalization of tumor marker levels; SD was defined as the persistence of one or more NTLs and/or maintenance of tumor marker level above the normal limits. Participants for whom no assessment of response was available and who had finalized the study due to disease progression or tumor-related death, disease progression was considered the BOR.


Enrollment: 153
Study Start Date: May 2007
Study Completion Date: November 2010
Primary Completion Date: November 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Rash, Grade <2
Participants with a rash graded less than (<) 2 according to the National Cancer Institute Common Toxicity Criteria (NCI-CTC) version (v.) 3.0 received erlotinib, 100 milligrams (mg), orally (PO), once per day until disease progression, unacceptable toxicity or refusal of patient to continue with the treatment. Participants also received gemcitabine, 1000 mg per (/) square meter (m^2), intravenously (IV), over 30 minutes on Days 1, 8 and 15 in 4-week cycles until disease progression, unacceptable toxicity or refusal of patient to continue with the treatment.
Drug: Erlotinib
100 mg, PO, once per day
Other Name: Tarceva
Drug: Gemcitabine
1000 mg/m2, IV, on Days 1, 8 and 15 in 4-week cycles
Experimental: Rash, Grade ≥2
Participants with a rash graded greater than or equal to (≥) 2 according to the NCI-CTC v. 3.0 received erlotinib, 100 mg, PO, once per day until disease progression, unacceptable toxicity or refusal of patient to continue with the treatment. Participants also received gemcitabine, 1000 mg/m^2, IV, over 30 minutes on Days 1, 8 and 15 in 4-week cycles until disease progression, unacceptable toxicity or refusal of patient to continue with the treatment.
Drug: Erlotinib
100 mg, PO, once per day
Other Name: Tarceva
Drug: Gemcitabine
1000 mg/m2, IV, on Days 1, 8 and 15 in 4-week cycles

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • adult patients, >=18 years of age;
  • locally advanced and/or metastatic pancreatic cancer (stage III or IV);
  • Karnofsky performance Status of >=60%.

Exclusion Criteria:

  • local(stage IA to IIB) pancreatic cancer;
  • <=6 months since last adjuvant chemotherapy;
  • previous systemic therapy for metastatic pancreatic cancer;
  • other primary tumor within last 5 years (except for adequately treated cancer in situ of cervix, or basal cell skin cancer);
  • clinically significant cardiovascular disease.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00461708

Locations
Spain
Alcoy, Alicante, Spain, 03804
Elche, Alicante, Spain, 03203
Manresa, Barcelona, Spain, 08243
Sabadell, Barcelona, Barcelona, Spain, 08208
Santander, Cantabria, Spain, 39008
Palma de Mallorca, Islas Baleares, Spain, 07198
La Coruna, La Coruña, Spain, 15006
Alcorcon, Madrid, Spain, 28922
Sagunto, Valencia, Spain, 46520
Barcelona, Spain, 08227
Barcelona, Spain, 08906
Barcelona, Spain, 08907
Barcelona, Spain, 08916
Cordoba, Spain, 14004
Girona, Spain, 17007
Granada, Spain, 18014
Guadalajara, Spain, 19002
Jaen, Spain, 23007
Lerida, Spain, 25198
Lugo, Spain, 27004
Madrid, Spain, 28040
Madrid, Spain, 28041
Murcia, Spain, 30008
Murcia, Spain, 30120
Navarra, Spain, 31008
Pontevedra, Spain, 36002
Sevilla, Spain, 41013
Valencia, Spain, 41014
Zaragoza, Spain, 50009
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT00461708     History of Changes
Other Study ID Numbers: ML20296 
Study First Received: April 17, 2007
Results First Received: November 10, 2014
Last Updated: September 14, 2015
Health Authority: Spain: Agencia Espanola del Medicamento (AEM)

Additional relevant MeSH terms:
Pancreatic Neoplasms
Neoplasm Metastasis
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases
Neoplastic Processes
Pathologic Processes
Gemcitabine
Erlotinib Hydrochloride
Pancrelipase
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Protein Kinase Inhibitors
Gastrointestinal Agents

ClinicalTrials.gov processed this record on July 21, 2016