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

NCT00461708 | Completed Phase 2 Results

• 1 other identifier: ML20296
• Study Type: interventional
• Target: 153
• Locations: 1 country
• Sites: 29

Brief Summary

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.

Conditions

Pancreatic Cancer

Outcome Measures

Primary Outcomes (2)

• Number of Participants Who Died During the Study

  Enrollment through Cycle 24 (4-week cycles), up to 24 months.

• Overall Survival (OS) During the Study

  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.

  Enrollment through Cycle 24 (4-week cycles), up to 24 months.

Secondary Outcomes (8)

• Number of Participants Who Died at 6 Months

  Enrollment through Cycle 6 (4-week cycles), up to 6 months.

• OS At 6 Months

  Enrollment through Cycle 6 (4-week cycles), up to 6 months.

• Number of Participants Who Died During the Study By Rash Grade

  Enrollment through Cycle 24 (4-week cycles), up to 24 months.

• OS By Rash Grade

  Enrollment through Cycle 24 (4-week cycles), up to 24 months.

• Number of Participants With Disease Progression or Death

  Enrollment, every 2 treatment cycles (4-week cycles) until disease progression, death, or end of study, for up to 24 months.

Study Arms (2)

Rash, Grade <2

EXPERIMENTAL

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; Drug: Gemcitabine

Rash, Grade ≥2

EXPERIMENTAL

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; Drug: Gemcitabine

Interventions

Erlotinib DRUG

100 mg, PO, once per day

Also known as: Tarceva

Rash, Grade <2; Rash, Grade ≥2

Gemcitabine DRUG

1000 mg/m2, IV, on Days 1, 8 and 15 in 4-week cycles

Rash, Grade <2; Rash, Grade ≥2

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hoffmann-La Roche: lead

Study Sites (29)

Unknown Facility

Alcoy, Alicante, 03804, Spain

Location

Unknown Facility

Elche, Alicante, 03203, Spain

Location

Unknown Facility

Palma de Mallorca, Balearic Islands, 07198, Spain

Location

Unknown Facility

Barcelona, Barcelona, 08227, Spain

Location

Unknown Facility

Barcelona, Barcelona, 08906, Spain

Location

Unknown Facility

Barcelona, Barcelona, 08907, Spain

Location

Unknown Facility

Barcelona, Barcelona, 08916, Spain

Location

Unknown Facility

Manresa, Barcelona, 08243, Spain

Location

Unknown Facility

Sabadell, Barcelona, Barcelona, 08208, Spain

Location

Unknown Facility

Santander, Cantabria, 39008, Spain

Location

Unknown Facility

Córdoba, Cordoba, 14004, Spain

Location

Unknown Facility

Girona, Girona, 17007, Spain

Location

Unknown Facility

Granada, Granada, 18014, Spain

Location

Unknown Facility

Guadalajara, Guadalajara, 19002, Spain

Location

Unknown Facility

Jaén, Jaen, 23007, Spain

Location

Unknown Facility

A Coruña, La Coruña, 15006, Spain

Location

Unknown Facility

Lleida, Lerida, 25198, Spain

Location

Unknown Facility

Lugo, Lugo, 27004, Spain

Location

Unknown Facility

Alcorcón, Madrid, 28922, Spain

Location

Unknown Facility

Madrid, Madrid, 28040, Spain

Location

Unknown Facility

Madrid, Madrid, 28041, Spain

Location

Unknown Facility

Murcia, Murcia, 30008, Spain

Location

Unknown Facility

Murcia, Murcia, 30120, Spain

Location

Unknown Facility

Navarra, Navarre, 31008, Spain

Location

Unknown Facility

Pontevedra, Pontevedra, 36002, Spain

Location

Unknown Facility

Seville, Sevilla, 41013, Spain

Location

Unknown Facility

Sagunto, Valencia, 46520, Spain

Location

Unknown Facility

Valencia, Valencia, 41014, Spain

Location

Unknown Facility

Zaragoza, Zaragoza, 50009, Spain

Location

MeSH Terms

Conditions

Pancreatic Neoplasms

Interventions

Erlotinib Hydrochloride; Gemcitabine

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Quinazolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring

Results Point of Contact

• Title: Medical Communications
• Organization: Hoffman-LaRoche

genentech@druginfo.com

800-821-8590

Study Officials

• Clinical Trials

  Hoffmann-La Roche

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 17, 2007
• First Posted: April 18, 2007
• Study Start: May 1, 2007
• Primary Completion: November 1, 2010
• Study Completion: November 1, 2010
• Last Updated: October 15, 2015
• Results First Posted: October 15, 2015

Record last verified: 2015-09

Locations

ES (29)