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Adenocarcinoma of the LungPhase 3NCT00005838

Combination Chemotherapy Plus Radiation Therapy With or Without AE-941 in Treating Patients With Stage III Non-small Cell Lung Cancer That Cannot Be Removed By Surgery

A Phase 3 study testing shark cartilage extract AE-941, cisplatin and vinorelbine tartrate in people with Adenocarcinoma of the Lung and Adenosquamous Cell Lung Cancer, run by National Cancer Institute (NCI) at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. Radiation therapy uses high-energy x-rays to damage tumor cells. AE-941 may help shrink or slow the growth of non-small cell lung cancer cells. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
shark cartilage extract AE-941, cisplatin and vinorelbine tartrate
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
756 participants
Where
1 siteUnited States
Study dates
Mar 2000to Feb 2007
Phase
Phase 3
Are there results?
None posted in the registry

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

  • Histologically or cytologically confirmed newly diagnosed, untreated, unresectable stage IIIA or stage IIIB non-small cell lung cancer
  • Squamous cell carcinoma, adenocarcinoma, or large cell carcinoma of the lung
  • Mixed tumors allowed if non-small cell elements identified
  • Contralateral supraclavicular and/or scalene lymph node involvement allowed
  • No disease extending into the cervical region
  • At least 1 bidimensionally or unidimensionally measurable lesion
Show all 34Show fewer
  • No pleural effusion unless cytologically negative or too small to safely aspirate
  • Not scheduled for curative cancer surgery
  • Performance status - ECOG 0-1
  • Absolute neutrophil count greater than 1,500/mm^3
  • Platelet count greater than 100,000/mm^3
  • Hematocrit greater than 30%
  • SGOT or SGPT less than 1.5 times upper limit of normal
  • Bilirubin normal
  • Creatinine less than 1.5 mg/dL
  • Creatinine clearance greater than 60 mL/min
  • No other major medical or psychiatric illness that would preclude study participation or consent
  • No medical condition that interferes with oral medication intake and/or absorption (gastrectomy or major intestinal resection)
  • No grade 2 or greater peripheral neuropathy unless secondary to mechanical etiology
  • No hypersensitivity to fish products
  • No more than 10% weight loss within past 3 months
  • No other malignancy within past 3 years except inactive carcinoma in situ of the cervix or nonmelanoma skin cancer
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • At least 30 days since prior chemotherapy
  • See Disease Characteristics
  • Recovered from prior major surgery
  • At least 30 days since prior shark cartilage products
  • No other concurrent investigational anticancer agents
  • No other concurrent cartilage products
  • No other concurrent investigational agents
  • No concurrent amifostine or other radioprotectants
  • No concurrent enrollment in other clinical trials

Who cannot join

None listed.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • M D Anderson Cancer Center

    Houston, Texas, 77030

Other trials in United States

About this study

Official title: Multicenter, Open-Ended, Double-Blind, Placebo-Controlled, Phase III Study of AE-941 in Addition to Combined Modality Treatment (Chemotherapy/Radiotherapy) for Locally Advanced Unresectable Non-Small Cell Lung Cancer

Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. Radiation therapy uses high-energy x-rays to damage tumor cells. AE-941 may help shrink or slow the growth of non-small cell lung cancer cells. It is not yet known if combination chemotherapy plus radiation therapy is more effective with or without AE-941 for non-small cell lung cancer. This randomized phase III trial is studying combination chemotherapy and radiation therapy given with AE-941 to see how well they work compared to combination chemotherapy and radiation therapy alone in treating patients with stage III non-small cell lung cancer that cannot be removed by surgery

Read the detailed description

PRIMARY OBJECTIVES:

  1. Determine the overall survival of patients with unresectable stage IIIA or IIIB non-small cell lung cancer treated with induction platinum-based chemotherapy and radiotherapy with or without AE-941 (Neovastat).

II. Determine the progression-free survival, tumor response, tumor response duration, and metastasis-free survival of patients treated with these regimens.

III. Determine the tolerability of this regimen in these patients.

OUTLINE: This is a randomized, double-blind, placebo-controlled, multicenter study. Patients are stratified according to stage (IIIA vs IIIB), type of platinum-based induction chemotherapy to be received (cisplatin and vinorelbine vs carboplatin and paclitaxel), and gender. Patients are randomized to 1 of 2 treatment arms.

Arm I: Patients receive oral AE-941 (Neovastat) twice daily beginning on day 1 or within 10 days of initiation of chemotherapy.

Arm II: Patients receive oral placebo twice daily beginning on day 1 or within 10 days of initiation of chemotherapy.

All patients receive induction chemotherapy with 1 of the following platinum-based regimens: cisplatin IV on days 1, 22, 50, and 71 and vinorelbine IV on days 1, 8, 22, 29, 50, 57, 71, and 78 carboplatin IV over 30 minutes and paclitaxel IV over 3 hours on days 1, 22, 50, 57, 64, 71, 78, and 85.

All patients receive radiotherapy beginning on day 50 for 6 weeks. Treatment in both arms continues in the absence of unacceptable toxicity.

Patients are followed every 3 months.

PROJECTED ACCRUAL: A total of 756 patients (378 per treatment arm) will be accrued for this study within 36 months.

Being tested
shark cartilage extract AE-941, placebo, cisplatin, vinorelbine tartrate, carboplatin
Medical subject headings
Adenocarcinoma of Lung, Carcinoma, Non-Small-Cell Lung

What participants receive

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

  • shark cartilage extract AE-941Drug

    Also called AE-941, Neovastat, Neovastat/AE-941

    Given orally

  • placeboOther

    Also called PLCB

    Given orally

  • cisplatinDrug

    Also called CACP, CDDP, CPDD, DDP

    Given IV

  • vinorelbine tartrateDrug

    Also called Eunades, navelbine ditartrate, NVB, VNB

    Given IV

  • carboplatinDrug

    Also called Carboplat, CBDCA, JM-8, Paraplat

    Given IV

  • paclitaxelDrug

    Also called Anzatax, Asotax, TAX, Taxol

    Given IV

  • radiation therapyRadiation

    Also called irradiation, radiotherapy, therapy, radiation

    Undergo radiotherapy

Study groups in NCT00005838
Study groupRoleWhat they receive
Arm I (shark cartilage extract AE-941)ExperimentalPatients receive oral AE-941 (Neovastat) twice daily beginning on day 1 or within 10 days of initiation of chemotherapy. All patients receive induction chemotherapy with 1 of the following platinum-based regimens: cisplatin IV on days 1, 22, 50, and 71 and vinorelbine IV on days 1, 8, 22, 29, 50, 57, 71, and 78 carboplatin IV over 30 minutes and paclitaxel IV over 3 hours on days 1, 22, 50, 57, 64, 71, 78, and 85. All patients receive radiotherapy beginning on day 50 for 6 weeks. Treatment in both arms continues in the absence of unacceptable toxicity.
Receives: Drug: shark cartilage extract AE-941; Drug: cisplatin; Drug: vinorelbine tartrate; Drug: carboplatin; Drug: paclitaxel; Radiation: radiation therapy
Arm II (placebo)Placebo comparatorPatients receive oral placebo twice daily beginning on day 1 or within 10 days of initiation of chemotherapy. All patients receive induction chemotherapy with 1 of the following platinum-based regimens: cisplatin IV on days 1, 22, 50, and 71 and vinorelbine IV on days 1, 8, 22, 29, 50, 57, 71, and 78 carboplatin IV over 30 minutes and paclitaxel IV over 3 hours on days 1, 22, 50, 57, 64, 71, 78, and 85. All patients receive radiotherapy beginning on day 50 for 6 weeks. Treatment in both arms continues in the absence of unacceptable toxicity.
Receives: Other: placebo; Drug: cisplatin; Drug: vinorelbine tartrate; Drug: carboplatin; Drug: paclitaxel; Radiation: radiation therapy

What is being measured

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

  1. Overall survival

    Survival distributions will be compared by use of the log-rank test. The stratified log-rank test (nominal or categorical covariates) may be used to simultaneously control for important prognostic factors. Kaplan-Meier curves will also be plotted to illustrate the comparative survival experience of both groups over the entire study period.

    Measured: From randomization until date of death or last follow-up, assessed up to 7 years

Secondary outcomes (4)

  1. Progression-free survival every 3 months

    Will be compared by use of the log-rank test. The stratified log-rank test (nominal or categorical covariates) may be used to simultaneously control for important prognostic factors. Kaplan-Meier curves will also be plotted.

    Measured: From randomization until disease progression, assessed up to 7 years

  2. Tumor response rate

    Will be compared by chi-square test.

    Measured: Up to 7 years

  3. Tumor response duration

    Will be compared by use of the log-rank test. The stratified log-rank test (nominal or categorical covariates) may be used to simultaneously control for important prognostic factors. Kaplan-Meier curves will also be plotted.

    Measured: From first observation of at least a partial response to detection of disease progression or death due to any cause, assessed up to 7 years

  4. Metastasis-free survival

    Will be compared by use of the log-rank test. The stratified log-rank test (nominal or categorical covariates) may be used to simultaneously control for important prognostic factors. Kaplan-Meier curves will also be plotted.

    Measured: From randomization until metastasis documented by imaging procedures, assessed up to 7 years

Timeline

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

  1. First posted27 Jan 2003 (estimated)
  2. Study startMar 2000
  3. Primary completionFeb 2007

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 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
756 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00005838
Sponsor's protocol ID
NCI-2012-02725
Other IDs
ID99-303, U10CA045809, CDR0000067853
Status last verified
Jan 2013
First submitted
2 Jun 2000
Last updated
23 Jan 2013
Results posted
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing shark cartilage extract AE-941, cisplatin and vinorelbine tartrate in people with Adenocarcinoma of the Lung and Adenosquamous Cell Lung Cancer, run by National Cancer Institute (NCI) at 1 site 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 34 inclusion and 0 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: finished, as of the sponsor's last update on 23 Jan 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Overall survival (time frame: From randomization until date of death or last follow-up, assessed up to 7 years). 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 NCT00005838.

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 23 Jan 2013.

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