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

NCT ID: NCT00005838

Last Updated: 2013-01-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 756 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2000-03-31

Brief 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. 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

Detailed Description

PRIMARY OBJECTIVES:

I. 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.

Conditions

Adenocarcinoma of the Lung; Adenosquamous Cell Lung Cancer; Large Cell Lung Cancer; Squamous Cell Lung Cancer; Stage IIIA Non-small Cell Lung Cancer; Stage IIIB Non-small Cell Lung Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Arm I (shark cartilage extract AE-941)

Patients 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.

Group Type: EXPERIMENTAL

shark cartilage extract AE-941

Intervention Type: DRUG

Given orally

cisplatin

Intervention Type: DRUG

Given IV

vinorelbine tartrate

Intervention Type: DRUG

Given IV

carboplatin

Intervention Type: DRUG

Given IV

paclitaxel

Intervention Type: DRUG

Given IV

radiation therapy

Intervention Type: RADIATION

Undergo radiotherapy

Arm II (placebo)

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.

Group Type: PLACEBO_COMPARATOR

placebo

Intervention Type: OTHER

Given orally

cisplatin

Intervention Type: DRUG

Given IV

vinorelbine tartrate

Intervention Type: DRUG

Given IV

carboplatin

Intervention Type: DRUG

Given IV

paclitaxel

Intervention Type: DRUG

Given IV

radiation therapy

Intervention Type: RADIATION

Undergo radiotherapy

Interventions

shark cartilage extract AE-941

Given orally

Intervention Type: DRUG

placebo

Given orally

Intervention Type: OTHER

cisplatin

Given IV

Intervention Type: DRUG

vinorelbine tartrate

Given IV

Intervention Type: DRUG

carboplatin

Given IV

Intervention Type: DRUG

paclitaxel

Given IV

Intervention Type: DRUG

radiation therapy

Undergo radiotherapy

Intervention Type: RADIATION

Other Intervention Names

AE-941; Neovastat; Neovastat/AE-941; PLCB; CACP; CDDP; CPDD; DDP; Eunades; navelbine ditartrate; NVB; VNB; Carboplat; CBDCA; JM-8; Paraplat; Paraplatin; Anzatax; Asotax; TAX; Taxol; irradiation; radiotherapy; therapy, radiation

Eligibility Criteria

Inclusion Criteria

• 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
• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Radiation Therapy Oncology Group

NETWORK

Sponsor Role: collaborator

National Center for Complementary and Integrative Health (NCCIH)

NIH

Sponsor Role: collaborator

National Cancer Institute (NCI)

NIH

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Charles Lu

Role: PRINCIPAL_INVESTIGATOR

M.D. Anderson Cancer Center

Locations

M D Anderson Cancer Center

Houston, Texas, United States

Countries

United States

Other Identifiers

ID99-303

Identifier Type: -

Identifier Source: secondary_id

U10CA045809

Identifier Type: NIH

Identifier Source: secondary_id

View Link

CDR0000067853

Identifier Type: REGISTRY

Identifier Source: secondary_id

NCI-2012-02725

Identifier Type: -

Identifier Source: org_study_id