Chemotherapy and Radiation in Treating Patients With Stage 3 Non-Small Cell Lung Cancer (PROCLAIM)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT00686959
First received: May 28, 2008
Last updated: February 27, 2014
Last verified: February 2014
  Purpose

This study will compare the overall survival of patients with locally advanced, Stage III Non-Small Cell Lung Cancer with nonsquamous cell histology.


Condition Intervention Phase
Non Small Cell Lung Cancer
Drug: Pemetrexed
Drug: Cisplatin
Drug: Etoposide
Drug: Vinorelbine
Drug: Paclitaxel
Drug: Carboplatin
Radiation: Thoracic Radiation Therapy (TRT)
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase 3 Study of Pemetrexed, Cisplatin, and Radiotherapy Followed by Consolidation Pemetrexed Versus Etoposide, Cisplatin, and Radiotherapy Followed by Consolidation Cytotoxic Chemotherapy of Choice in Patients With Unresectable, Locally Advanced, Stage III Non-Small Cell Lung Cancer Other Than Predominantly Squamous Cell Histology

Resource links provided by NLM:


Further study details as provided by Eli Lilly and Company:

Primary Outcome Measures:
  • Overall survival [ Time Frame: Baseline to date of death from any cause ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Compare progression-free survival (PFS) between the 2 arms [ Time Frame: Baseline to measured progressive disease ] [ Designated as safety issue: No ]
  • Compare objective response rate (complete response [CR] + partial response [PR])between the 2 arms [ Time Frame: Baseline to measured progressive disease ] [ Designated as safety issue: No ]
  • Adverse events [ Time Frame: Every cycle ] [ Designated as safety issue: Yes ]
  • Compare 1-, 2-, and 3-year absolute survival rates between arms [ Time Frame: Baseline to date of death from any cause ] [ Designated as safety issue: Yes ]
  • Compare first site of disease failure in terms of relapse between the 2 arms [ Time Frame: Baseline to relapse ] [ Designated as safety issue: No ]
  • To assess patient-reported outcomes (PROs) between the 2 arms using a swallowing diary [ Time Frame: Baseline through Post Study ] [ Designated as safety issue: No ]

Estimated Enrollment: 600
Study Start Date: September 2008
Estimated Study Completion Date: September 2014
Estimated Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm A Drug: Pemetrexed

Concurrent Phase: 500 mg/m2, IV on Day 1 of each 21-day cycle x 3 cycles.

Consolidation Phase: 500 mg/m2, IV on Day 1 of each 21-day cycle up to 4 cycles.

Other Names:
  • Alimta
  • LY231514
Drug: Cisplatin

Concurrent Phase: 75 mg/m2, IV on Day 1 of each 21-day cycle x 3 cycles.

Consolidation Phase: Not applicable.

Radiation: Thoracic Radiation Therapy (TRT)

Concurrent Phase: Beginning on day 1 of chemotherapy, once daily fractions (2 Gy per day), 5 days a week for 6 weeks and 3 days to target 66 Gy in 33 fractions.

Consolidation Phase: Not applicable.

Active Comparator: Arm B Drug: Etoposide

Concurrent Phase: 50 mg/m2, IV, Days 1-5 of each 28-day cycle x 2 cycles.

Consolidation Phase: 50 mg/m2, IV, Days 1-5 of each 28-day cycle up to 2 cycles.

Drug: Cisplatin

Concurrent Phase: 50 mg/m2, IV, Day 1 and 8 of each 28-day cycle x 2 cycles.

Consolidation Phase (with Etoposide): 50 mg/m2, IV, Day 1 and 8 of each 28-day cycle up to 2 cycles.

Consolidation Phase (with Vinorelbine): 75 mg/m2, IV, Day 1 of each 21-day cycle x 2 cycles.

Drug: Vinorelbine
Consolidation Phase only (with Cisplatin): 30 mg/m2, IV, Day 1 and 8 of each 21-day cycle x 2 cycles.
Drug: Paclitaxel
Consolidation Phase only (with Carboplatin): 200 mg/m2, IV on Day 1 of each 21-day cycle x 2 cycles.
Drug: Carboplatin
Consolidation Phase only (with Paclitaxel): AUC6, IV, Day 1 of each 21-day cycle x 2 cycles.
Radiation: Thoracic Radiation Therapy (TRT)

Concurrent Phase: Beginning on day 1 of chemotherapy, once daily fractions (2 Gy per day), 5 days a week for 6 weeks and 3 days to target 66 Gy in 33 fractions.

Consolidation Phase: Not applicable.


  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • You must have Stage 3A or 3B Non-Small Cell Lung Cancer of the non-squamous type
  • You must have measureable tumor lesions according to the Response Evaluation Criteria in Solid Tumors (RECIST) guidelines or disease that can be evaluated on CT scan
  • You must at least be able to physically be mobile, take care of yourself and must be up and about and able to perform light activities such as light housework or office work
  • 18 years of age or older
  • You have lost no more than 10% of body weight in the previous three months
  • Women must be sterile, postmenopausal or on contraception and men must be sterile or on contraception
  • Your test results assessing the function of your blood forming tissue, kidneys, liver and lungs are satisfactory

Exclusion Criteria:

  • You cannot have other on-going illnesses including active infections, recent heart problems or psychiatric illnesses
  • You are unable to take vitamins (including injections of vitamin B12) or oral cortisone medication
  • You cannot have had a heart attack or other cardiac issues within 6 months of the trial
  • You cannot have received other investigational drugs within the last 30 days
  • You are unable to stop taking more than 1.3 grams of aspirin on a daily basis or non-steroidal anti-inflammatory agents.
  • You cannot have had previous chest radiation, however, other prior radiation is allowed if it was at least 30 days prior to the trial and limited in extent.
  • You cannot have a radiation treatment plan that would expose more than 35% of your unaffected lung to 20 Gy or more of radiation
  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: NCT00686959

  Show 133 Study Locations
Sponsors and Collaborators
Eli Lilly and Company
Investigators
Study Director: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST) Eli Lilly and Company
  More Information

Additional Information:
No publications provided

Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT00686959     History of Changes
Other Study ID Numbers: 11514, H3E-MC-JMIG
Study First Received: May 28, 2008
Last Updated: February 27, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Carcinoma, Bronchogenic
Bronchial Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Paclitaxel
Etoposide
Vinorelbine
Etoposide phosphate
Pemetrexed
Cisplatin
Carboplatin
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Radiation-Sensitizing Agents
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Antimetabolites, Antineoplastic

ClinicalTrials.gov processed this record on September 29, 2014