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Recurrent Lung Non-Small Cell CarcinomaPhase 1NCT00254384

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

A Phase 1 study testing Cisplatin, Docetaxel and Erlotinib in people with Recurrent Lung Non-Small Cell Carcinoma and Stage IA Lung Non-Small Cell Carcinoma AJCC v7, run by M.D. Anderson Cancer Center at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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… Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Cisplatin, Docetaxel and Erlotinib
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
50 participants
Where
1 siteUnited States
Study dates
5 Oct 2005to 21 May 2024
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
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  • 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

Who cannot join

  • Patients who have had prior chemotherapy or radiotherapy for lung cancer
  • Patients may not be receiving any other investigational agents within 30 days of trial entry, including anti-EGFR drugs
  • 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 refusing to sign the informed consent
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  • Patients with pre-existing peripheral neuropathy National Cancer Institute (NCI) Common Toxicity Criteria (CTC) grade 2 or worse
  • 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
  • Patients with a history of severe hypersensitivity reaction to Taxotere and or polysorbate 80 must be excluded

Trial locations and contacts

1 site in 1 country.

United States1 site

  • M D Anderson Cancer Center

    Houston, Texas, 77030

Other trials in United States

About this study

Official title: 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

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.

Read the detailed description

PRIMARY OBJECTIVES:

  1. To evaluate the safety/toxicity of neoadjuvant chemotherapy with cisplatin and docetaxel followed by maintenance therapy with the epidermal growth factor receptor (EGFR) inhibitor erlotinib (erlotinib hydrochloride) in patients with stage I-III non-small cell lung cancer (NSCLC) undergoing definitive treatment with surgery and/or radiation.

II. To estimate the agreement in baseline to post-treatment changes of EGFR expression (i.e., EGFR modulation) between buccal smears and bronchial tissue.

SECONDARY OBJECTIVES:

  1. To evaluate the disease free survival of this therapeutic combination. II. To assess overall quality of life. III. To evaluate predictive biomarkers in early-stage NSCLC.

OUTLINE:

Patients receive docetaxel intravenously (IV) over 1 hour followed by cisplatin IV over 30-60 minutes on day 1. Treatment repeats every 21 days for 3 courses in the absence of disease progression or unacceptable toxicity. Beginning within 90 days following definitive surgical resection, patients receive erlotinib hydrochloride orally (PO) daily for up to 1 year.

After completion of study treatment, patients are followed up every 3 months for 1 year and then every 6 months for 4 years.

Being tested
Cisplatin, Docetaxel, Erlotinib, Erlotinib Hydrochloride, Laboratory Biomarker Analysis
Medical subject headings
Carcinoma, Non-Small-Cell Lung

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CisplatinDrug

    Also called Abiplatin, Blastolem, Briplatin, CDDP

    Given IV

  • DocetaxelDrug

    Also called Docecad, RP56976, Taxotere, Taxotere Injection Concentrate

    Given IV

  • ErlotinibDrug

    Given PO

  • Erlotinib HydrochlorideDrug

    Also called Cp-358,774, OSI-774, Tarceva

    Given PO

  • Laboratory Biomarker AnalysisOther

    Correlative studies

Study groups in NCT00254384
Study groupRoleWhat they receive
Treatment (docetaxel, cisplatin, erlotinib hydrochloride)ExperimentalPatients receive docetaxel IV over 1 hour followed by cisplatin IV over 30-60 minutes on day 1. Treatment repeats every 21 days for 3 courses in the absence of disease progression or unacceptable toxicity. Beginning within 90 days following definitive surgical resection, patients receive erlotinib hydrochloride PO daily for up to 1 year.
Receives: Drug: Cisplatin; Drug: Docetaxel; Drug: Erlotinib; Drug: Erlotinib Hydrochloride; Other: Laboratory Biomarker Analysis

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Rate of grade 3 or greater toxicities (hematologic or non-hematologic)

    Measured: Up to 5 years post-treatment

  2. Changes of EGFR expression (i.e., EGFR modulation) between buccal smears and bronchial tissue

    Agreement will be estimated using the kappa coefficient. An important aspect of this trial is to identify changes in expression of potential biomarkers between buccal smears and bronchial tissues after induction (neoadjuvant) platinum-based therapy in early-stage , resectable non-small cell lung cancers. As part of the primary outcome measures, we plan to measure the EGFR expression changes (i.e. EGFR modulation) between buccal smears and bronchial tissues after induction therapy.

    Measured: From baseline up to 5 years post-treatment

Secondary outcomes (3)

  1. Incidence of EGFR mutations

    The frequency of EGFR mutations in resected tumor specimens following neoadjuvant platinum-based therapy will be evaluated.

    Measured: Up to 5 years post-treatment

  2. Evaluation of immune-based biomarkers

    The correlation among various continuous and discrete biomarkers will be assessed first by exploratory data analysis using scatter plot matrix, bx plots, BLiP plot, and trellis plots. Correlation among continuous biomarkers will be estimated by Pearson or Spearman rank correlation coefficient. The association on discrete biomarkers will be tested by chi-square or Fisher's exact test. McNamar's test will be applied to test the change of a single discrete biomarker over time.

    Measured: Up to 5 years post-treatment

  3. Time to progression

    Estimated by Kaplan-Meier method. The Cox (proportional hazards) model will be fitted to estimate the effect of biomarker and other covariates on survival.

    Measured: Up to 5 years post-treatment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Nov 2005 (estimated)
  2. Study start5 Oct 2005
  3. Primary completion21 May 2024
  4. Study completion21 May 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
50 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00254384
Sponsor's protocol ID
2004-0221
Other IDs
NCI-2012-01560, NCI-2010-00817, 2004-0221
Status last verified
Jul 2024
First submitted
14 Nov 2005
Last updated
5 Jul 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No

Publications

  • Cascone T, Gold KA, Swisher SG, Liu DD, Fossella FV, Sepesi B, Pataer A, Weissferdt A, Kalhor N, Vaporciyan AA, Hofstetter WL, Wistuba II, Heymach JV, Kim ES, William WN Jr. Induction Cisplatin Docetaxel Followed by Surgery and Erlotinib in Non-Small Cell Lung Cancer. Ann Thorac Surg. 2018 Feb;105(2):418-424. doi: 10.1016/j.athoracsur.2017.08.052. Epub 2017 Dec 6.

    PubMed 29217088

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Cisplatin, Docetaxel and Erlotinib in people with Recurrent Lung Non-Small Cell Carcinoma and Stage IA Lung Non-Small Cell Carcinoma AJCC v7, run by M.D. Anderson Cancer Center at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 16 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 5 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Rate of grade 3 or greater toxicities (hematologic or non-hematologic) (time frame: Up to 5 years post-treatment). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00254384, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jul 2024.

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