NCT00553462|CompletedPhase 2Results

Carboplatin and Paclitaxel Albumin-Stabilized Nanoparticle Formulation Followed by Radiation Therapy and Erlotinib in Treating Patients With Stage III Non-Small Cell Lung Cancer That Cannot Be Removed By Surgery

A Phase II Study of Induction Chemotherapy Followed by Thoracic Radiotherapy and Erlotinib in Poor-Risk Stage III Non-Small Cell Lung Cancer

Alliance for Clinical Trials in Oncology ClinicalTrials.gov

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2 other identifiers

CALGB-30605CDR0000573832

Study Type

interventional

Target

Locations

1 country

Sites

Timeline

RegisteredNov 2007

StartedMar 2008

CompletionJun 2017

Brief Summary

RATIONALE: Drugs used in chemotherapy, such as carboplatin and paclitaxel albumin-stabilized nanoparticle formulation, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high-energy x-rays to kill tumor cells. Erlotinib may make tumor cells more sensitive to radiation therapy. Giving carboplatin and paclitaxel albumin-stabilized nanoparticle formulation together with radiation therapy and erlotinib may kill more tumor cells. PURPOSE: This phase II trial is studying how well giving carboplatin and paclitaxel albumin-stabilized nanoparticle formulation together with radiation therapy and erlotinib works in treating patients with stage III non-small cell lung cancer that cannot be removed by surgery.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

participants targeted

Target at P50-P75 for phase_2 lung-cancer

Timeline

Completed

Started Mar 2008

Longer than P75 for phase_2 lung-cancer

Geographic Reach

1 country

99 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

9.3 years study duration

First Submitted

Initial submission to the registry

November 2, 2007

Completed

3 days until next milestone

First Posted

Study publicly available on registry

November 5, 2007

Completed

4 months until next milestone

Study Start

First participant enrolled

March 1, 2008

Completed

5.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2014

Completed

3.1 years until next milestone

Results Posted

Study results publicly available

January 20, 2017

Completed

5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 15, 2017

Completed

Last Updated

January 31, 2018

Status Verified

January 1, 2018

Enrollment Period

5.8 years

First QC Date

November 2, 2007

Results QC Date

November 23, 2016

Last Update Submit

January 8, 2018

Conditions

Lung Cancer

Keywords

stage IIIA non-small cell lung cancerstage IIIB non-small cell lung canceradenocarcinoma of the lungbronchoalveolar cell lung cancerlarge cell lung cancersquamous cell lung cancer

Outcome Measures

Primary Outcomes (1)

Overall Survival at 12 Months
Percentage of participants who were alive at 12 months.
At 12 months

Secondary Outcomes (2)

Response Rate
Duration of study (up to 2 years)
Progression-free Survival
Duration of study (up to 2 years)

Study Arms (1)

paclitaxel + carboplatin + radiation + erlotinib

EXPERIMENTAL

Patients receive paclitaxel IV over 30 minutes on days 1 and 8 and carboplatin IV over 30 minutes on day 1. Treatment repeats every 21 days for 2 courses. Patient with rapid disease progression outside of the chest after induction therapy are removed from study. Patients with intrathoracic disease progression within the potential radiation field may continue protocol therapy at the discretion of the Study Chair. Patients with no disease progression outside the planned radiation field (either regional or distant) proceed to concurrent erlotinib hydrochloride and radiotherapy. Beginning on day 43 (week 7), patients receive oral erlotinib hydrochloride once daily. Patients also undergo concurrent radiotherapy 5 days a week for up to 7 weeks (33 fractions) in the absence of rapid disease progression outside of the chest or unacceptable toxicity. After completion of study therapy, patients are followed every 3 months for 1 year, and then every 6 months for up to 2 years

Drug: carboplatinDrug: erlotinib hydrochlorideDrug: paclitaxel albumin-stabilized nanoparticle formulationRadiation: radiation therapy

Interventions

carboplatinDRUG

paclitaxel + carboplatin + radiation + erlotinib

erlotinib hydrochlorideDRUG

paclitaxel + carboplatin + radiation + erlotinib

paclitaxel albumin-stabilized nanoparticle formulationDRUG

paclitaxel + carboplatin + radiation + erlotinib

radiation therapyRADIATION

paclitaxel + carboplatin + radiation + erlotinib

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

DISEASE CHARACTERISTICS: * Histologically or cytologically confirmed non-small cell lung cancer (NSCLC), including any of the following histologies: * Squamous cell carcinoma * Adenocarcinoma (including bronchoalveolar cell) * Large cell anaplastic carcinoma (including giant and clear cell carcinomas) * Must meet the following criteria: * T1-3 with N2 and selected N3\* * T4 with N0, N1, N2 and selected N3\* * M0 (no M1 patients) NOTE: \*Patients with contralateral mediastinal disease (i.e., N3) are eligible, provided all gross disease can be encompassed within the radiation boost field in accordance with the homogeneity criteria. Patients with ipsilateral scalene or supraclavicular disease are also eligible. Patients with contralateral hilar or supraclavicular node involvement are not eligible. * Must have measurable disease, defined as ≥ 1 unidimensionally measurable lesion ≥ 20 mm by conventional techniques or ≥ 10 mm by spiral CT scan * Nonmeasurable lesions include the following: * Bone lesions * Leptomeningeal disease * Ascites * Pleural or pericardial effusion * Abdominal masses that are not confirmed and followed by imaging techniques * Cystic lesions * Tumor lesions situated in a previously irradiated area * Patients must be considered unresectable or inoperable AND be deemed candidates for combined modality therapy by a medical oncologist and a radiation oncologist * Considered to be poor-risk with NCI CTC performance status (PS) 2 OR PS 0-1 and ≥ 10% weight loss within the past 3 months * Patients with tumors adjacent to a vertebral body are eligible, provided all gross disease can be encompassed within the radiation boost field in accordance with the homogeneity criteria * Pleural effusions meeting the following criteria allowed: * Effusion is transudate, cytologically negative, and non-bloody * Effusion can be seen on the chest CT scan but not on the chest x-ray AND is too small to tap * Effusion appears only after a thoracotomy or other invasive thoracic procedure was attempted PATIENT CHARACTERISTICS: * See Disease Characteristics * Granulocytes ≥ 1,500/μL * Platelet count ≥ 100,000/μL * Creatinine ≤ 1.5 x upper limit of normal (ULN) * AST \< 2 x ULN * Bilirubin ≤ ULN * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: * No prior chemotherapy or radiotherapy for NSCLC * At least 2 weeks since formal exploratory thoracotomy * No concurrent administration of sucralfate suspension and erlotinib hydrochloride * No concurrent intensity-modulated radiotherapy * No concurrent hormones or other chemotherapeutic agents except steroids given for adrenal failure, hormones administered for non-disease-related conditions (e.g., insulin for diabetes), and intermittent use of dexamethasone as an antiemetic * No concurrent palliative radiotherapy

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

Sponsors & Collaborators

Alliance for Clinical Trials in Oncologylead
National Cancer Institute (NCI)collaborator

Study Sites (99)

East Bay Radiation Oncology Center

Castro Valley, California, 94546, United States

Location

Valley Medical Oncology Consultants - Castro Valley

Castro Valley, California, 94546, United States

Location

Valley Medical Oncology

Fremont, California, 94538, United States

Location

Contra Costa Regional Medical Center

Martinez, California, 94553-3156, United States

Location

Camino Medical Group - Treatment Center

Mountain View, California, 94040, United States

Location

El Camino Hospital Cancer Center

Mountain View, California, 94040, United States

Location

Highland General Hospital

Oakland, California, 94602, United States

Location

Alta Bates Summit Medical Center - Summit Campus