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NCT00254384CompletedPhase 1

Docetaxel, Cisplatin, and Erlotinib Hydrochloride in Treating Patients With Stage I-III Non-small Cell Lung Cancer Following Surgery

Neoadjuvant Chemotherapy With Docetaxel, Cisplatin Followed by Maintenance Therapy With the EGFR Inhibitor Erlotinib (Tarceva) in Patients With Stage I, II and III Non-Small Cell Lung Cancer Following Definitive Surgical Resection

Source: ClinicalTrials.gov · Last updated 5 Jul 2024

Brief summary (registry, in English)

This phase I trial studies docetaxel, cisplatin, and erlotinib hydrochloride in treating patients with stage I-III non-small cell lung cancer following surgery. Drugs used in chemotherapy, such as docetaxel and cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Erlotinib hydrochloride may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving docetaxel, cisplatin, and erlotinib hydrochloride together may kill more tumor cells.

Status (registry)
Completed
Phase (registry)
Phase 1
Study type
Interventional
Enrollment
50 (actual)
First submitted
14 Nov 2005
Start date
5 Oct 2005
Primary completion date
21 May 2024
Lead sponsor
M.D. Anderson Cancer Center
Diseases
Lung cancer
NCT number
NCT00254384

What you commit to

  • Study type: Interventional · Phase 1
  • Participants enrolled: 50
  • From 5 Oct 2005 to the primary completion date, 21 May 2024
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Patients who have had prior chemotherapy or radiotherapy for lung cancer
  • Patients must not be pregnant or breast-feeding and all (male and female) must use a contraceptive method deemed acceptable by the investigator while receiving active treatment in the study and for up to two months following completion of therapy

Other illness

  • Patient has signs or symptoms of acute infection requiring systemic therapy
  • Patient exhibits confusion, disorientation, or has a history of major psychiatric illness that may impair patient's understanding of the informed consent
  • Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure (New York Heart Association Functional Classification class II or worse), unstable angina pectoris, serious or clinically significant cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
  • Patients with pre-existing peripheral neuropathy National Cancer Institute (NCI) Common Toxicity Criteria (CTC) grade 2 or worse
  • Patients with a history of severe hypersensitivity reaction to Taxotere and or polysorbate 80 must be excluded

Lab values

  • Patients may not be receiving any other investigational agents within 30 days of trial entry, including anti-EGFR drugs

Other

  • Patients refusing to sign the informed consent

Who the study is looking for

  • Patients must have histologically or cytologically confirmed diagnosis of stage I, II or III non-small cell lung cancer; tissue blocks or slides will be requested
  • Patients must have surgically resectable disease and may not be treated with prior chemotherapy or radiation
  • Patients must be able to tolerate systemic chemotherapy prior to surgical resection
  • No acute intercurrent illness or infection
  • Eastern Cooperative Oncology Group (ECOG) performance status 0-1
  • Leukocytes \>= 3,000/uL
  • Absolute neutrophil count (ANC) \>= 1,500/uL
  • Platelets \>= 100,000/uL
  • Hemoglobin \>= 8g/dL
  • Creatinine within normal institutional limits OR creatinine clearance \>= 60 mL/min/1.73 m\^2 for patients with creatinine levels above institutional normal
  • Bilirubin within normal institutional limits
  • Alkaline phosphatase (alk phos) =\< 2.5 x upper limit of normal (ULN); if alk phos \> 2.5 x ULN but =\< 5 x ULN, patient is eligible if AST or ALT =\< ULN
  • Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) =\< 1.5 x ULN; if AST or ALT \> 1.5 x ULN but =\< 5 x ULN, patient is eligible if alk phos is =\< ULN
  • Prior to study enrollment, all women of child-bearing potential must have a negative pregnancy test; women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of study participation, and for 2 months after the completion of therapy; should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately
  • Patients with a history of non-melanoma skin cancer, or other malignancies treated 5 years or more prior to the current tumor, from which the patient has remained continually disease-free, are eligible
  • Ability to understand and the willingness to sign a written informed consent document

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
M D Anderson Cancer Center
Coordinator of this site? Confirm its status
HoustonUnited StatesUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.