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Lung CancerPhase 1/2NCT00544648

Ph I/II Nab-Paclitaxel & Carboplatin w/Concurrent Radiation Therapy for Unresectable Stg III NSCLC

A Phase 1/2 study testing carboplatin, nab-paclitaxel and Radiation therapy in people with Lung Cancer, run by Vanderbilt-Ingram Cancer Center at 6 sites in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

RATIONALE: Drugs used in chemotherapy, such as carboplatin, 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Lung Cancer
What is being tested?
carboplatin, nab-paclitaxel and Radiation therapy
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
13 participants
Where
6 sitesUnited States
Study dates
Nov 2007to Apr 2014
Phase
Phase 1/2
Are there results?
Yes, posted in the registrySummary in the doctors' view

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 voluntarily sign and date an informed consent before the initiation of any study procedures
  • Patients must have non-metastatic, inoperable, Stage IIIA or IIIB histologically or cytologically documented NSCLC without evidence of malignant pleural effusion
  • Patients must not have received any prior systemic chemotherapy, thoracic radiotherapy or surgical resection for treatment of NSCLC
  • Patients must have at least one site of unidirectionally measurable disease as defined by Response Evaluation in Solid Tumors (RECIST) criteria
  • Patients must be ≥ 3 weeks from a formal exploratory thoracotomy
  • Patients must have a Radiation Oncology and Medical Oncology consult and approval prior to study entry
Show all 20Show fewer
  • Patients must be ≥ 18 years of age
  • Patients must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
  • Women of childbearing potential must have a negative baseline serum pregnancy or a negative urine pregnancy test within 7 days prior to Week 1, Day 1 and must not be breast feeding.
  • Women of childbearing potential and men with a sexual partner of child bearing potential must use an effective method of contraception beginning prior to study entry, for the duration of the study participation and for a minimum of 3 months after the last dose of chemotherapy.
  • Patients must have adequate hepatic, renal, lung and bone marrow function as defined below:
  • Absolute neutrophil count (ANC) ≥1,500/mm3
  • Hemoglobin ≥ 9.0 gm/dL
  • Serum Creatinine ≤1.5mg/dl
  • Platelets > 100,000/mm3
  • Total bilirubin ≤ upper limit of normal
  • AST and ALT < 2.5 X upper limit of normal
  • Alkaline phosphatase < 2.5 X upper limit of normal
  • Calculated CrCl > 45 ml/min (via Cockroft-Gault formula)
  • Forced expiratory volume in 1 second (FEV 1) > 800 ml

Who cannot join

  • Known hypersensitivity to carboplatin or nab-paclitaxel
  • Peripheral neuropathy Grade ≥ 2
  • Wet stage IIIB (documented malignant pleural effusion) or stage IV NSCLC
  • Previous chemotherapy or radiation therapy to the chest
  • Any concomitant malignancy or brain metastasis
  • Any uncontrolled, clinically significant medical or psychiatric disorder
  • Pregnant or nursing women
  • A greater than or equal to 10% weight loss over the past 3 months

Trial locations and contacts

6 sites in 1 country.

6 sites in 1 country

United States6 sites

  • Erlanger Cancer Center at Erlanger Hospital - Baroness

    Chattanooga, Tennessee, 37403

  • Vanderbilt-Ingram Cancer Center - Cool Springs

    Nashville, Tennessee, 37064

  • Vanderbilt-Ingram Cancer Center at Franklin

    Nashville, Tennessee, 37064

  • Vanderbilt-Ingram Cancer Center

    Nashville, Tennessee, 37232-6838

  • Purchase Cancer Group - Paducah

    Paducah, Kentucky, 42002

  • Oregon Health Sciences University

    Portland, Oregon, 97201

Other trials in United States

About this study

Official title: A Phase I/II Study of Nab-Paclitaxel and Carboplatin With Concurrent Radiation Therapy for Unresectable Stage III Non-Small-Cell Lung Cancer (NSCLC)

RATIONALE: Drugs used in chemotherapy, such as carboplatin, 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. Nab-paclitaxel (paclitaxel albumin-stabilized nanoparticle formulation) may make tumor cells more sensitive to radiation therapy. Giving nab-paclitaxel together with radiation therapy and carboplatin may kill more tumor cells.

PURPOSE: This phase I/II trial is studying the side effects and best dose of giving nab-paclitaxel together with carboplatin and radiation therapy and to see how well it works in treating patients with stage III non-small-cell lung cancer that cannot be removed by surgery.

Read the detailed description

OBJECTIVES:

Primary

  • To determine the maximum tolerated dose of nab-paclitaxel when combined concurrently with carboplatin and radiation followed by two courses of nab-paclitaxel carboplatin as consolidation. (Phase I)
  • To evaluate the progression-free survival in patients with stage III unresectable non-small cell lung cancer treated with nab-paclitaxel, carboplatin, and radiotherapy followed by two courses of nab-paclitaxel with carboplatin as consolidation. (Phase II)

Secondary

  • To assess safety and tolerability and identify dose-limiting toxicities in patients receiving nab-paclitaxel combined concurrently with carboplatin and radiotherapy. (Phase I)
  • To assess progression-free survival, response rates, and survival. (Phase I)
  • To assess overall survival and response rates in all patients treated on this study. (Phase II)
  • To assess the safety and tolerability of patients receiving nab-paclitaxel combined concurrently with carboplatin and radiotherapy followed by two courses of nab-paclitaxel/carboplatin as consolidation. (Phase II) OUTLINE: This is a multicenter study.
  • Phase I:
  • Concurrent chemoradiotherapy: Patients receive escalating doses of nab-paclitaxel IV over 30 minutes and carboplatin IV over 30 minutes on days 1, 8, 15, 22, 29, 36, and 43. They also receive conformal radiotherapy once daily 5 days a week on days 1-5 in weeks 1-7. Patients are evaluated between weeks 8-10. Patients with disease progression are removed from study. Patients with stable disease, partial response, or complete response proceed to consolidation chemotherapy 3 weeks after completion of chemoradiotherapy.
  • Consolidation chemotherapy: Patients receive nab-paclitaxel IV over 30 minutes on days 1, 8, and 15 and carboplatin IV over 30 minutes on day 1. Treatment repeats ever 21 days for up to 2 courses.
  • Phase II: Patients receive concurrent chemoradiotherapy at the Maximum Tolerated Dose (MTD) of nab-paclitaxel followed by consolidation chemotherapy as in phase I.

After completion of study treatment, patients are followed at 2 months, every 3 months for 2 years, every 4 months for 2 years, and then every 6 months thereafter.

PROJECTED ACCRUAL: A total of 98 patients (15 patients for phase I and 83 patients for phase II) will be accrued for this study.

Conditions
Lung Cancer
Being tested
carboplatin, nab-paclitaxel, Radiation therapy
Keywords
stage IV non-small cell lung cancer, stage IIIB non-small cell lung cancer
Medical subject headings
Lung Neoplasms, Carcinoma, Non-Small-Cell Lung

What participants receive

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

  • carboplatinDrug

    Also called Paraplatin

    (AUC 2) through a vein over 30 minutes following nab-paclitaxel, once per week x 7 weeks

  • nab-paclitaxelDrug

    Also called paclitaxel albumin-stabilized nanoparticle formulation, Abraxane

    Phase I: beginning at 40 mg/m2 through a vein over 30 minutes once per week x 7 weeks Phase II: Maximum tolerated dose through a vein over 30 minutes once per week x 7 weeks

  • Radiation therapyRadiation

    3D conformal radiotherapy or Intensity-Modulated Radiation Therapy (IMRT), 2.0 Gy per day x 5 days per week for 33 days during Weeks 1-7 ; Total Dose = 66 Gy

Study groups in NCT00544648
Study groupRoleWhat they receive
TreatmentExperimentalnab-paclitaxel+ carboplatin + radiation
Receives: Drug: carboplatin; Drug: nab-paclitaxel; Radiation: Radiation therapy

What is being measured

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

  1. Maximum Tolerated Dose of Nab-paclitaxel When Combined Concurrently With Carboplatin and Radiation (Phase I)

    The highest dose in milligrams per meter of body surface squared (mg/m2) of nab-paclitaxel in combination with carboplatin while maintaining tolerability. Cohorts of 3-6 patients received escalating doses of nab-paclitaxel in combination with carboplatin until the maximum tolerated dose (MTD) was achieved. The MTD is defined as the dose preceding that at which 2 or more of 6 patients experience dose-limiting toxicity (DLT) during the initial cycle of therapy. DLTs per Common Toxicity Criteria v 3.0: recurring non-hematological (except esophagitis) > Grade 2, non-hematological or esophagitis > Grade 3 toxicities that are symptomatically unacceptable to patient and result in treatment delay for > 2 weeks, persistent toxicity resulting in treatment delay for > 2 weeks.

    Measured: 7 weeks

  2. Progression-free Survival (Phase II)

    Estimated probable duration of life without disease progression, from on-study date to earlier of progression date, or date of death from any cause, using the Kaplan-Meier method with censoring (see Analysis Population Description for additional details). Disease progression is defined by Response Evaluation in Solid Tumors (RECIST) v.1.1: >= 20% increase in sum of the longest diameter of target lesions, unequivocal progression of non-target lesions, or appearance of new lesions

    Measured: On-study to lesser of date of progression or date of death from any cause (assessed up to 2 years)

Secondary outcomes (7)

  1. Progression-free Survival (Phase I)

    Estimated probable duration of life without disease progression, from on-study date to earlier of progression date, or date of death from any cause, using the Kaplan-Meier method with censoring (see Analysis Population Description for additional details). Disease progression is defined by Response Evaluation in Solid Tumors (RECIST) v.1.1: >= 20% increase in sum of the longest diameter of target lesions, unequivocal progression of non-target lesions, or appearance of new lesions

    Measured: On-study to lesser of date of progression or date of death from any cause (assessed up to 2 years)

  2. Overall Survival (Phase I)

    Estimated probable duration of life from on-study date to date of death from any cause, using Kaplan-Meier method with censoring (see Analysis Population Description for additional details).

    Measured: On-study date to date of death from any cause (assessed up to 2 years)

  3. Response (Phase I)

    Number of patients in each response category, per Response Evaluation in Solid Tumors (RECIST) v.1.1: complete response (CR), disappearance of target lesions; partial response (PR) >=30% decrease in sum of longest diameter (LD) of target lesions; progressive disease (PD), >=20% increase in sum of LD of target lesions or appearance of new lesions; stable disease (SD), insufficient change in target lesions or new lesions to qualify as either PD or PR. Patients are categorized according to the best response achieved prior to occurrence of progressive disease, where best response hierarchy is CR>PR>SD>PD.

    Measured: On-treatment date to date of progressive disease (assessed up to 2 years)

  4. Number of Patients With Each Worst Grade Toxicity (Phase I)

    Count of patients according to the worst-grade toxicity (WGT) experienced by each, where worst-grade toxicity is per NCI common toxicity criteria: Grade 1, mild; Grade 2, moderate; Grade 3, severe; Grade 4, life-threatening; Grade 5, death.

    Measured: On-study date to 30 days following final dose of study drug

  5. Overall Survival (Phase II)

    Estimated probable duration of life from on-study date to date of death from any cause, using Kaplan-Meier method with censoring (see Analysis Population Description for additional details. Too few patients were enrolled in the Phase II arm for an analysis of overall survival

    Measured: Time Frame: date on study to date of death from any cause or last known date alive

  6. Number of Patients With Each Worst Grade Toxicity (Phase II)

    The number of patients with worst-grade toxicity at each of five grades following NCI Common Toxicity Criteria: 1 = mild, 2 = moderate, 3 = severe, 4 = life-threatening, disabling, 5 = death

    Measured: at 16 weeks

  7. Response (Phase II)

    Number of patients in each response category, per Response Evaluation in Solid Tumors (RECIST) v.1.1: complete response (CR), disappearance of target lesions; partial response (PR) >=30% decrease in sum of longest diameter (LD) of target lesions; progressive disease (PD), >=20% increase in sum of LD of target lesions or appearance of new lesions; stable disease (SD), insufficient change in target lesions or new lesions to qualify as either PD or PR. Patients are categorized according to the best response achieved prior to occurrence of progressive disease, where best response hierarchy is CR>PR>SD>PD.

    Measured: On-treatment date to date of progressive disease (assessed up to 2 years)

Timeline

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

  1. First posted16 Oct 2007 (estimated)
  2. Study startNov 2007
  3. Primary completionApr 2014
  4. Study completionApr 2014

Why it stopped: Ph I completed. Funding became unavailable causing Ph II to cease after two patients were enrolled.

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 1/2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
13 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00544648
Sponsor's protocol ID
VICC THO 0746
Other IDs
P30CA068485, VU-VICC-THO-0746
Status last verified
May 2014
First submitted
13 Oct 2007
Last updated
9 Jun 2014
Data monitoring committee
Yes

Publications

  • Lammers PE, Lu B, Horn L, Shyr Y, Keedy V. nab-Paclitaxel in Combination With Weekly Carboplatin With Concurrent Radiotherapy in Stage III Non-Small Cell Lung Cancer. Oncologist. 2015 May;20(5):491-2. doi: 10.1634/theoncologist.2015-0030. Epub 2015 Apr 6.

    PubMed 25845992

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing carboplatin, nab-paclitaxel and Radiation therapy in people with Lung Cancer, run by Vanderbilt-Ingram Cancer Center at 6 sites 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 20 inclusion and 8 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: stopped early, as of the sponsor's last update on 9 Jun 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 sites 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 combined 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.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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

Are results available for this study?

Yes. Results are posted in the registry (first posted 9 Jun 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Maximum Tolerated Dose of Nab-paclitaxel When Combined Concurrently With Carboplatin and Radiation (Phase I) (time frame: 7 weeks). 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 NCT00544648, 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 9 Jun 2014.

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