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Phase II Trial of Induction Gemcitabine and Carboplatin Followed by Paclitaxel and Carboplatin With Concurrent Thoracic Radiation for Patients With Unresectable Stage IIIA/IIIB Non-Small Cell Lung Cancer


Phase 2
18 Years
N/A
Not Enrolling
Both
Lung Cancer

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Trial Information

Phase II Trial of Induction Gemcitabine and Carboplatin Followed by Paclitaxel and Carboplatin With Concurrent Thoracic Radiation for Patients With Unresectable Stage IIIA/IIIB Non-Small Cell Lung Cancer


In this trial we adopted the approach of using both induction and concurrent chemotherapy
together with Thoracic Radiation Therapy (TRT) planned conformally to a tumor dose of 74 Gy.
Substitution of gemcitabine for paclitaxel in the induction chemotherapy allowed us to
evaluate the impact of RRM1 expression on the activity of this agent. The expression of
Ribonucleotide Reductase, M1 Subunit (RRM1) was evaluated prior to initiation of therapy,
following induction chemotherapy but prior to concurrent chemoradiation, and following
completion of all therapy by CT-guided core needle biopsies. This is a single institution
phase II clinical trial, of induction treatment with gemcitabine and carboplatin followed by
concurrent chemoradiation using paclitaxel and carboplatin and daily thoracic radiation to a
total dose of 74 Gy for patients with unresectable Stage IIIA and IIIB NSCLC. The specific
clinical objectives of this study are as follows: To determine the response rate (both CT
scan and PET scan assessment) to two cycles of induction chemotherapy with gemcitabine and
carboplatin; To determine the response rate (both CT scan and PET scan assessment) to
concurrent thoracic radiation and weekly paclitaxel and carboplatin; To evaluate the
patterns of local and distant failure for patients treated with induction chemotherapy
followed by concurrent chemoradiation according to this regimen; To estimate the median, 1
year, and overall survival; To assess acute and long term toxicities of treatment.

Inclusion Criteria


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.

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Number of Participants Whose Response Allowed Them to Proceed to Chemoradiation

Outcome Description:

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.

Outcome Time Frame:

Ranging from 2 weeks up to 4 years, 9 months

Safety Issue:

No

Principal Investigator

Gerold Bepler, MD, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

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

Authority:

United States: Food and Drug Administration

Study ID:

MCC-13240

NCT ID:

NCT00226590

Start Date:

April 2003

Completion Date:

July 2008

Related Keywords:

  • Lung Cancer
  • non-small cell lung cancer
  • carcinoma
  • unresectable
  • Stage IIIA
  • Stage IIIB
  • thoracic radiation
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms

Name

Location

H. Lee Moffitt Cancer Center & Research InsituteTampa, Florida  33612