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Alimta and Gemcitabine in Non-Small Cell Lung Cancer (ANGEL)

This study has been completed.
Sponsor:
Information provided by:
Southern Italy Cooperative Oncology Group
ClinicalTrials.gov Identifier:
NCT00434135
First received: February 9, 2007
Last updated: February 4, 2009
Last verified: February 2009
  Purpose

The aims of this study are: (1) to assess the safety and activity of gemcitabine plus Alimta (pemetrexed) regimen (GA regimen) in patients with advanced NSCLC patients in the context of a randomized trial, and (2) to compare the GA with the paclitaxel plus gemcitabine (PG regimen) in terms of toxicity and QoL


Condition Intervention Phase
Non-Small Cell Lung Cancer
Stage IIIB or IV
Drug: gemcitabine plus pemetrexed, paclitaxel plus gemcitabine
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase II Randomized Trial Assessing the Combination of Gemcitabine and Pemetrexed in the First Line Treatment of Locally Advanced or Metastatic Non-Small Cell Lung Cancer

Resource links provided by NLM:


Further study details as provided by Southern Italy Cooperative Oncology Group:

Primary Outcome Measures:
  • Response rate of patients treated with the gemcitabine plus Alimta regimen [ Time Frame: after 3 cycles ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Safety of patients treated with gemcitabine plus Alimta regimen [ Time Frame: at the end of treatment ] [ Designated as safety issue: Yes ]
  • Quality of life of patients treated with gemcitabine plus Alimta regimen [ Time Frame: after 3 cyces ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 180
Study Start Date: May 2006
Study Completion Date: October 2008
Primary Completion Date: October 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A
Gemcitabine 1,250 mg/sqm days 1 and 8 + Alimta 500 mg/sqm day 8, every 3 weeks
Drug: gemcitabine plus pemetrexed, paclitaxel plus gemcitabine
gemcitabine 1,250 mg/sqm days 1&8 + pemetrexed 500 mg/sqm day 8 paclitaxel 120 mg/sqm + gemcitabine 1,000 mg/sqm days 1&8
Active Comparator: B
Paclitaxel 120 mg/sqm days 1 and 8 + Gemcitabine 1,000 mg/sqm days 1 and 8, every 3 weeks
Drug: gemcitabine plus pemetrexed, paclitaxel plus gemcitabine
gemcitabine 1,250 mg/sqm days 1&8 + pemetrexed 500 mg/sqm day 8 paclitaxel 120 mg/sqm + gemcitabine 1,000 mg/sqm days 1&8

Detailed Description:

Patients with stage IIIB or IV non-small cell lung cancer will be randomly allocated to receive: (a)PG regimen: paclitaxel 120 mg/sqm followed by gemcitabine 1,000 mg/sqm i.v. on days 1 & 8 q 3 weeks; (b)GA regimen: gemcitabine 1,250 mg/sqm i.v. on day 1 (plus folinic acid 350 μg daily orally and vitamin B12 1,000 μg i.m. q 9 weeks), pemetrexed (Alimta®) 500 mg/sqm i.v. on day 8 followed by gemcitabine 1,250 mg/sqm, q 3 weeks.

  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Patients with histologically or cytologically confirmed locally advanced (stage IIIB) or metastatic (stage IV) NSCLC
  2. No previous adjuvant or palliative chemotherapy
  3. No previous radiotherapy
  4. Presence of at least one unidimensionally measurable lesion (Appendix 2)
  5. ECOG performance status of 0 or 1 (Appendix 3)
  6. Charlson score ≤ 2 (Appendix 4)
  7. Adequate bone marrow function (absolute neutrophil count ≥ 2 x 109/L, platelet count ≥ 100 x 109/L, and hemoglobin level ≥ 100 g/L), and adequate liver function (bilirubin level < two times the upper limit of normal, AST and/or ALT < three times the upper limit of normal, prothrombin time < 1.5 times control), and creatinine clearance ≥ 60 ml/min.
  8. Absence of symptomatic CNS metastases (patients with cerebral metastases treated with brain irradiation may be included), severe cardiac arrhythmia or heart failure, second or third degree heart block or acute myocardial infarction within 4 months prior to study entry.
  9. No major surgery or pleurodesis within 14 days prior to enrollment.
  10. Life expectancy of at least 12 weeks.
  11. No previous or concurrent malignancy, except inactive non-melanoma skin cancer, in situ carcinoma of the cervix, or other cancer if the patient has been disease-free for more than 5 years.
  12. Written informed consent

Exclusion Criteria:

  1. Any unstable systemic disease (including active infection, uncontrolled hypertension, unstable angina, congestive heart failure, serious cardiac arrhythmia requiring medication, hepatic, renal or metabolic disease).
  2. Patients with clinically significant effusions.
  3. Any other malignancies within 5 years that could affect therapy evaluation
  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: NCT00434135

Locations
Italy
National Tumor Institute
Naples, Italy, 80131
Sponsors and Collaborators
Southern Italy Cooperative Oncology Group
Investigators
Principal Investigator: Pasquale Comella, MD National Tumor Institute, Naples, Italy
  More Information

No publications provided

Responsible Party: Pasquale Comella MD, Southern Italy Cooperative Oncology Group
ClinicalTrials.gov Identifier: NCT00434135     History of Changes
Other Study ID Numbers: SICOG trial 0506
Study First Received: February 9, 2007
Last Updated: February 4, 2009
Health Authority: Italy: Ministry of Health

Keywords provided by Southern Italy Cooperative Oncology Group:
gemcitabine
pemetrexed
non-small cell lung cancer

Additional relevant MeSH terms:
Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Bronchial Neoplasms
Carcinoma, Bronchogenic
Lung Diseases
Neoplasms
Neoplasms by Site
Respiratory Tract Diseases
Respiratory Tract Neoplasms
Thoracic Neoplasms
Gemcitabine
Paclitaxel
Pemetrexed
Anti-Infective Agents
Antimetabolites
Antimetabolites, Antineoplastic
Antimitotic Agents
Antineoplastic Agents
Antineoplastic Agents, Phytogenic
Antiviral Agents
Enzyme Inhibitors
Folic Acid Antagonists
Immunologic Factors
Immunosuppressive Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Radiation-Sensitizing Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on November 20, 2014