Induction Chemotherapy Using Paclitaxel, Carboplatin, CPT-11 With Pegfilgrastim

NCT00280787 | Completed Phase 2 DMC

• 1 other identifier: LCCC 0215
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

Patients enrolled on this study will have been diagnosed with non-small cell lung cancer which cannot be removed by an operation. The standard treatment for this disease is a combination of chemotherapy and radiation therapy; however, the best way to combine these treatments is not known. This study will examine if the combination of chemotherapy and radiotherapy has an increased effect on slowing tumor growth with the addition of a drug called ZD1839. In this study, chemotherapy will be given initially (induction therapy) to try to control the spread of the cancer. Then radiation and chemotherapy will be given together. Receiving chemotherapy at the same time as radiation treatments can enhance the effect of the radiation. In this study, patients will receive a drug called ZD1839. In laboratory tests on cancer cells, ZD1839 has shown an additive effect when used in combination with radiation. ZD1839 has also been shown to slow or stop growth in tumors. The purpose of this study is to determine the side effects and effectiveness of using ZD1839 when used with radiation in this treatment regimen (induction chemotherapy followed by combination chemotherapy, ZD1839, and radiation therapy).

Conditions

Non Small Cell Lung Cancer

Keywords

unresectable; induction; radiotherapy; ZD1839

Outcome Measures

Primary Outcomes (2)

• Number of subjects experiencing toxicity

  Toxicity of the combination of induction carboplatin/paclitaxel/irinotecan, followed by concurrent carboplatin/paclitaxel/ZD1839 and high-dose TCRT, will be assessed by CTCAE criteria

  60 days

• Efficacy of 2 cycles of induction paclitaxel/carboplatin/irinotecan

  To estimate the efficacy of 2 cycles (42 days) of induction paclitaxel/carboplatin/irinotecan, followed by concurrent carboplatin/paclitaxel/ZD1839 using RECIST criteria to evualate tumor response.

  42 days

Secondary Outcomes (1)

• Progression Free Survival

  5 years

Interventions

Paclitaxel DRUG

175 mg/m2 administered on Day 1, of a 21 day cycle. Subjects will receive 2 cycles

Also known as: Taxol

Carboplatin DRUG

Area Under the Curve(AUC)=5 administered on Day 1 of a 21 day cycle. Subjects will receive 2 cycles.

Also known as: Paraplatin

CPT-11 DRUG

100 mg/m2 administered on Day 1 of each 21 day cycle. Subjects will receive 2 cycles.

Also known as: Irinotecan

Pegfilgrastim DRUG

6 mg administered on Day 2 each each 21 day cylce. Subjects will receive 2 cycles of treatment.

Also known as: Neulasta

Conformal radiotherapy RADIATION

Radiation therapy will be administered with standard daily fractionation of 2.0 Gy per fraction, 5 days per week.The total dose of radiotherapy will be 74 Gy

Eligibility Criteria

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

You may qualify if:

• Subjects 18 years of age or older.
• Subjects with histologically or cytologically confirmed NSCLC that is considered generally unresectable or inoperable. No prior chemotherapy for NSCLC or thoracic radiotherapy is allowed.
• Subjects with Stage IIIA or IIIB disease (clinically or surgically staged).
• Subject with disease designated T3, N0-N1 based on mediastinal invasion or proximity to the carina.
• Subjects with contralateral mediastinal disease (N3) are eligible if all gross disease can be encompassed within the radiation port.
• Subjects with pleural fluid that is a transudate and is cytologically negative.
• Subjects with pleural effusions that are seen only on CT scan and are too small to tap.
• Subjects with measurable or evaluable disease.
• Subjects with PS of 0 or 1 by the ECOG scale (see Appendix 2).
• Subjects with laboratory values as follows:
• Absolute granulocyte count: ≥1,500/µL Platelets: ≥100,000/µL Total bilirubin: ≤1.5 x institutional upper normal limit Serum creatinine: \<1.6 mg/dL or Creatinine clearance:\>40 mL/min
• AST and ALT: ≤2.5 x institutional upper normal limit FEV 1 \>800 cc
• Subjects must be nonpregnant and non-lactating. Subjects of childbearing potential must implement an effective method of contraception during the study. All female subjects, except those who are postmenopausal or surgically sterilized, must have a negative pre-study serum or urine pregnancy test.
• Subjects must have a life expectancy \> 2 months.
• Subjects must be seen by both a medical oncologist and a radiation oncologist before registration.

You may not qualify if:

• Subjects with disease designated T3, N0-N1 based on chest wall invasion, subjects with N3 supraclavicular disease, or subjects with superior sulcus tumors.
• Subjects with cytologically positive pleural effusions.
• Subjects who have received prior chemotherapy or radiochemotherapy for lung cancer or prior chest radiotherapy.
• Subjects who are \< 3 weeks since formal exploratory thoracotomy.
• Subjects with a history of other cancers except in situ carcinoma of the cervix or breast, inactive nonmelanomatous skin cancer, or other cancer, unless the subject has been free of disease for \> 5 years.
• Also, exceptions can be made by the PI for a subject with a malignancy for which the prognosis is substantially better than the subject's prognosis for NSCLC.
• Subjects with an active serious infection or other serious underlying medical condition that would otherwise impair their ability to receive protocol treatment. Subjects with post-obstructive pneumonia remain eligible.
• Subjects with dementia or significantly altered mental status that would prohibit the understanding and/or giving of informed consent.
• Pregnant or breast-feeding females or subjects not using adequate methods of birth control.
• Subjects receiving other investigational therapy or non-approved therapy within 30 days before Day 1 of protocol treatment.
• Subjects with known hypersensitivity to E coli-derived proteins, pegfilgrastim, or any component of the product will be excluded.
• Subjects with metastatic disease are excluded.
• Subjects taking phenytoin, rifampicin, barbiturates, carbamazepine, or St. John's Wort.
• Any evidence of clinically active ILD (subjects with chronic stable radiographic changes who are asymptomatic need not be excluded).
• Subjects with evidence of any other significant clinical disorder or laboratory finding that makes it undesirable for the subject to participate in the trial.

Sponsors & Collaborators

• UNC Lineberger Comprehensive Cancer Center: lead
• AstraZeneca: collaborator
• Amgen: collaborator

Study Sites (1)

University of North Carolina Lineberger Comprehensive Cancer Center

Chapel Hill, North Carolina, 27599, United States

Location

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

Paclitaxel; Carboplatin; Irinotecan; pegfilgrastim; Radiotherapy, Conformal

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)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Coordination Complexes; Camptothecin; Alkaloids; Heterocyclic Compounds; Radiotherapy, Computer-Assisted; Radiotherapy; Therapeutics

Study Officials

• David Morris, MD

  University of North Carolina, Chapel Hill

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 19, 2006
• First Posted: January 23, 2006
• Study Start: November 1, 2003
• Primary Completion: January 1, 2006
• Study Completion: October 1, 2010
• Last Updated: February 5, 2013

Record last verified: 2013-02

Locations

US (1)