Induction Gemcitabine & Carboplatin Followed by Paclitaxel & Carboplatin +XRT in NSCLC

NCT00226590 | Completed Phase 2 Results DMC

• 2 other identifiers: MCC-1324013189
• Study Type: interventional
• Target: 39
• Locations: 1 country
• Sites: 1

Brief Summary

This is a single institution Phase II study for patients with unresectable Stage IIIA and IIIB non-small cell lung cancer. The treatment started with 2 cycles of gemcitabine and carboplatin followed by concurrent chemotherapy with radiation. The chemoradiation included using paclitaxel and carboplatin with daily thoracic radiation to a total dose of 74 Gy. Response rate was determined following the chemotherapy with gemcitabine and carboplatin and evaluated again after the chemoradiation. Treatment toxicities were also assessed.

Conditions

Lung Cancer

Keywords

non-small cell lung cancer; carcinoma; unresectable; Stage IIIA; Stage IIIB; thoracic radiation

Outcome Measures

Primary Outcomes (1)

• Number of Participants Whose Response Allowed Them to Proceed to Chemoradiation

  Response Rates - Complete Response (CR) + Partial Response (PR): We determined the number of participants whose response (both CT and PET assessment) to two cycles of induction chemotherapy with gemcitabine and carboplatin allowed them to proceed to chemoradiation. Response was evaluated using the new international criteria proposed by the Response Evaluation Criteria in Solid Tumors (RECIST) Committee.

  Ranging from 2 weeks up to 4 years, 9 months

Secondary Outcomes (3)

• Progression Free Survival

  Ranging from 2 weeks up to 4 years, 9 months

• Overall Survival

  Ranging from 2 weeks up to 4 years, 9 months

• Treatment Completion

  Ranging from 2 weeks up to 4 years, 9 months

Study Arms (1)

Combined Therapy

EXPERIMENTAL

In this trial we adopted the approach of using both induction and concurrent chemotherapy together with TRT planned conformally to a tumor dose of 74 Gy.

Drug: Gemcitabine; Drug: Carboplatin; Drug: Paclitaxel; Procedure: Radiation

Interventions

Gemcitabine DRUG

Induction Chemotherapy.

Also known as: Gemzar

Combined Therapy

Carboplatin DRUG

Induction Chemotherapy. Weekly Carboplatin and Paclitaxel During Thoracic Radiation Therapy.

Also known as: Paraplatin

Combined Therapy

Paclitaxel DRUG

Weekly Carboplatin and Paclitaxel During Thoracic Radiation Therapy.

Also known as: Taxol

Combined Therapy

Radiation PROCEDURE

Radiation Therapy will begin on day 57 if there has been adequate hematologic recovery from Induction Chemotherapy.

Also known as: Radiation Therapy

Combined Therapy

Eligibility Criteria

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

Eligibility Criteria: * Histologically confirmed unresectable non-small cell carcinoma of the lung (adenocarcinoma, squamous cell carcinoma or anaplastic large cell carcinoma). See below for TNM eligibility. Mediastinoscopy or thoracoscopy in patients with mediastinal lymph node enlargement of \< 2 cm on CT scans of suspicious on PET scan to confirm suspected involvement. These staging procedures are not mandatory for patients with obvious nodal involvement (2.0 cm or greater). Staging system: The New International Staging System for lung cancer (Clifton F. Mountain, 1997) will be followed. The following stages will be eligible: * Patients with stage IIIa disease will be eligible if it is felt that they are not candidates for possible resection following neo-adjuvant therapy (unresectable T3N1 or T1-3 primary tumors with metastasis limited to single station ipsilateral mediastinal lymph nodes). Patients with stage IIIb disease without significant\* pleural effusion will be eligible. This includes patients with metastases to contralateral mediastinal or supraclavicular nodes. * Patients without significant pleural effusion will constitute those in whom 1) it is seen on CT scan only or 2) does not reaccumulate after one thoracentesis and is cytologically negative. * No evidence of distant metastasis. * Patients must have measurable disease by the Recist Evaluation Criteria in Solid Tumors (RECIST) criteria. Baseline measurements/evaluations must be obtained within 4 weeks prior to registration. * Patients must not have small cell carcinoma as part of the histological specimen (World Health Organization \[WHO\] classification 22.40) * Performance status of Eastern Cooperative Oncology Group (ECOG) 0 or 1 at time of registration. * Patients with preexisting clinically significant peripheral neuropathy are ineligible. * Weight loss of ≤ 5% in the preceding three months * No prior systemic chemotherapy or thoracic radiotherapy. * Patients must have adequate bone marrow reserve as determined by the following laboratory values: Obtained within 14 days prior to registration. * White blood cell count 4000/ul or greater and granulocyte count of 1500/ul or greater * Platelet count of 100,000/ul or greater * Hemoglobin of 10 gms/dl or greater. * Adequate renal and liver function as determined by the following laboratory values: Obtained within 14 days prior to registration. * Serum creatinine \< 1.5 mg/dl or creatinine clearance greater than 50 cc/min * Bilirubin less than 1.5 mg/dl * SGOT less than 1.5 times normal * No history of a prior or concomitant malignancy in the past five years except for surgically cured basal cell carcinoma of the skin or carcinoma in situ of the cervix. * No concomitant life threatening or uncontrolled serious medical illness such as cardiac arrhythmia, end stage congestive heart failure, liver disease with significant hepatic insufficiency, organic brain syndrome. * Women of childbearing potential and sexually active males are strongly advised to use an accepted and effective method of contraception. * Age greater than or equal to 18 years * Written, informed consent must be obtained prior to registration.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• H. Lee Moffitt Cancer Center and Research Institute: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

H. Lee Moffitt Cancer Center & Research Insitute

Tampa, Florida, 33612, United States

Location

MeSH Terms

Conditions

Lung Neoplasms; Carcinoma, Non-Small-Cell Lung; Carcinoma

Interventions

Gemcitabine; Carboplatin; Paclitaxel; Radiation; Radiotherapy

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Carcinoma, Bronchogenic; Bronchial Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type

Intervention Hierarchy (Ancestors)

Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Coordination Complexes; Organic Chemicals; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Diterpenes; Terpenes; Physical Phenomena; Therapeutics

Results Point of Contact

• Title: Gerald Bepler, M.D., Ph.D., c/o Moffitt Cancer Center
• Organization: Karmanos Cancer Institute (formerly at Moffitt Cancer Center)

beplerg@karmanos.org

813-745-4398

Study Officials

• Gerold Bepler, MD, PhD

  Karmanos Cancer Institute (formerly at H. Lee Moffitt Cancer Center & Research Institute)

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

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: September 23, 2005
• First Posted: September 27, 2005
• Study Start: April 1, 2003
• Primary Completion: July 1, 2008
• Study Completion: July 1, 2008
• Last Updated: March 23, 2017
• Results First Posted: May 23, 2011

Record last verified: 2011-05

Locations

US (1)