Pemetrexed Followed by Docetaxel or in Reverse Sequence

NCT01442909 | Completed Phase 4 DMC

• 1 other identifier: 97-02-09
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

Brief Summary

Both pemetrexed and docetaxel have been reported to have similar activity against non-small cell lung cancer (NSCLC) who failed previous chemotherapy in a large randomized phase III study. However, no study showed different toxicity and efficacy profiles within individual patients. Present phase II randomized clinical trial is designed to answer these questions, with addition of information about whether or not sequential therapy can prolong disease-free and overall survival.

Conditions

Non-small-cell Lung Cancer

Keywords

lung cancer; docetaxel; pemetrexed

Outcome Measures

Primary Outcomes (1)

• Incidence of grade III or IV leukopenia during treatment

  one year

Secondary Outcomes (1)

• progression-free survival

  one year

Study Arms (2)

D followed by P

ACTIVE COMPARATOR

Docetaxel 60 mg/m2 intravenous infusion (IV) day 1 every 3 weeks for 4-6 cycles (stable disease up to 4 cycles, partial or complete response up to 6 cycles), followed by pemetrexed 500 mg/m2 IV day 1 every 3 weeks for 4-6 cycles (stable disease up to 4 cycles, partial or complete response up to 6 cycles).

Drug: Docetaxel and pemetrexed

P followed by D

ACTIVE COMPARATOR

Pemetrexed treatment followed by docetael (in reverse sequence of Arm "D followed by P"

Drug: Docetaxel and pemetrexed

Interventions

Docetaxel and pemetrexed DRUG

docetaxel 60mg/m2 every 3 weeks for 4 cycles followed by pemetrexed 500mg/m2 every 3 weeks for 4 cycles; or in reverse sequence.

Also known as: taxotere, alimta

D followed by P; P followed by D

Eligibility Criteria

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

You may qualify if:

• histologically or cytologically confirmed non-small cell bronchogenic carcinoma, inoperable stage IIIB or IV
• aged 18 years or older
• failed previous platinum-based chemotherapy
• presence of at least one measurable disease which is defined as lesion that can be measured in at least 1 dimension as ≥ 20 mm with conventional CT or ≥ 10 mm with spiral CT scan
• performance status of Eastern Cooperative Oncology Group (ECOG) 0, 1, or 2
• white blood cell (WBC) ≥ 3,000/mm3, absolute neutrophil count (ANC) ≥ 1,500/mm3, platelets ≥ 100,000/mm3 and hemoglobin ≥ 10 mg / dl
• serum creatinine level 2.0 mg/dL or lower
• serum bilirubin less than 1.5 times the upper limit of normal range (ULN)
• alanine aminotransferase (ALT) or aspartate aminotransferase (AST) less than 3 times the ULN (less than 5 times the ULN in liver metastases)
• written informed consent to participate in the trial In addition, in female patient with childbearing potential, either terminated by surgery, radiation, or menopause, or attenuated by use of an approved contraceptive method (intrauterine contraceptive device \[IUD\], birth control pills, or barrier device) during and for three months after trial. Patients who previously treated by surgery are needed to demonstrate progressive disease before entering the study.

You may not qualify if:

• Active infection (at the discretion of the investigator).
• Active central nervous system (CNS) metastases.
• Breast feeding.
• Serious concomitant systemic disorders incompatible with the study (at the discretion of the investigator).
• Use of any investigational agent in the month before enrollment into the study.
• Concomitant myelosuppressive radiotherapy to target lesion, chemotherapy, hormonal therapy, or immunotherapy will not be allowed.

Sponsors & Collaborators

• Taipei Veterans General Hospital, Taiwan: lead

Study Sites (1)

Taipei VGH

Taipei, 112, Taiwan

Location

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung; Lung Neoplasms

Interventions

Docetaxel; Pemetrexed

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; 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

Study Officials

• Yuh-Min Chen, MD, PhD.

  Chest Department, Taipei VGH

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 25, 2008
• First Posted: September 29, 2011
• Study Start: March 1, 2008
• Primary Completion: September 1, 2009
• Study Completion: September 1, 2009
• Last Updated: September 29, 2011

Record last verified: 2011-09

Locations

TW (1)