Pemetrexed and Cisplatin as Treatment in Small Cell Lung Cancer

NCT00475657 | Terminated Phase 2 Results

• 2 other identifiers: 11473H3E-XM-S113
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 6

Brief Summary

The purpose of this study is to determine if cisplatin and pemetrexed are effective in the treatment of patients with Small Cell Lung Cancer, extended disease.

Conditions

Small Cell Lung Cancer

Outcome Measures

Primary Outcomes (1)

• Overall Response Rate

  Trial terminated - results not analyzed

  baseline to measured progressive disease

Secondary Outcomes (4)

• Overall Survival

  baseline to date of death from any cause

• Progression Free Survival

  baseline to measured progressive disease

• Duration of Response

  time of response to progressive disease

• Stable Disease Rate

  baseline to measured progressive disease

Study Arms (1)

A

EXPERIMENTAL

Drug: pemetrexed; Drug: cisplatin

Interventions

pemetrexed DRUG

500 mg/m2, intravenous (IV), every 21 days x 6 cycles

Also known as: LY231514, Alimta

A

cisplatin DRUG

75 mg/m2, intravenous (IV), every 21 days x 6 cycles

A

Eligibility Criteria

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

You may qualify if:

• Histologic or cytologic diagnosis of Small Cell Lung Cancer (SCLC).
• Functional stage from 0 to 2 of the ECOG functional scale
• No previous systemic chemotherapy, immunotherapy or biologic therapy for SCLC.
• Previous bone marrow radiotherapy less than 25% is allowed.
• There must be at least one measurable lesion that complies with the solid tumor response evaluation criteria.
• Appropriate organic function.
• Life expectancy estimated at 12 weeks minimum.
• Females must be surgically sterile, postmenopausal or follow approved medical contraceptive methods during the treatment period and 6 months afterwards. Males must be surgically sterile or use a contraceptive method during the treatment period and during 6 months after treatment.
• The patient must be compliant and located close to the trial area for appropriate follow-up.
• The patient or his/her legal representative must sign an informed consent document.
• Patients must be at least 18 years of age.

You may not qualify if:

• Having received treatment for the last 30 days with a drug that has not obtained regulatory approval.
• Having participated in a previous pemetrexed trial.
• Mixed histologic diagnosis of SCLC and NSCLC.
• Concurrent illness.
• Having an active infection.
• Severe cardiac disease.
• Having received recently or concurrently a vaccine against yellow fever.
• Having suffered a previous malignant process other than SCLC.
• Central nervous system (CNS) metastases require concurrent corticoid therapy. Treated and stable CNS metastases are allowed.
• Clinically relevant fluid accumulation in the third space.
• Concurrent administration of any other anti-tumor treatment.
• Severe renal failure.
• Unable to discontinue administration of non-steroidal anti-inflammatory (NSAIDS) agents.
• Inability or unwillingness to take folic acid and vitamin B12 supplements.
• Inability to take corticoids.

Sponsors & Collaborators

• Eli Lilly and Company: lead

Study Sites (6)

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

A Coruña, 15002, Spain

Location

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

Ferrol, 15405, Spain

Location

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

Lugo, 27004, Spain

Location

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

Ourense, 15009, Spain

Location

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

Santiago de Compostela, 15706, Spain

Location

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

Vigo, 36211, Spain

Location

Related Links

• Lilly Clinical Trial Registry

MeSH Terms

Conditions

Small Cell Lung Carcinoma

Interventions

Pemetrexed; Cisplatin

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Guanine; Hypoxanthines; Purinones; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Glutamates; Amino Acids, Acidic; Amino Acids; Amino Acids, Peptides, and Proteins; Amino Acids, Dicarboxylic; Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds

Limitations and Caveats

On the advice of an independent monitoring board, this trial was stopped early due to lack of efficacy of the combination pemetrexed/carboplatin for small cell lung cancer.

Results Point of Contact

• Title: Chief Medical Officer
• Organization: Eli Lilly and Company

1-800-545-5979

Study Officials

• 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

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• 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

Study Record Dates

• First Submitted: May 16, 2007
• First Posted: May 21, 2007
• Study Start: October 1, 2007
• Primary Completion: April 1, 2008
• Study Completion: April 1, 2008
• Last Updated: May 29, 2009
• Results First Posted: May 25, 2009

Record last verified: 2009-05

Locations

ES (6)