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
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Purpose
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
| Condition | Intervention | Phase |
|---|---|---|
|
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 |
Drug: shark cartilage extract AE-941 Other: placebo Drug: cisplatin Drug: vinorelbine tartrate Drug: carboplatin Drug: paclitaxel Radiation: radiation therapy |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment |
| 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 |
- Overall survival [ Time Frame: From randomization until date of death or last follow-up, assessed up to 7 years ] [ Designated as safety issue: No ]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.
- Progression-free survival every 3 months [ Time Frame: From randomization until disease progression, assessed up to 7 years ] [ Designated as safety issue: No ]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.
- Tumor response rate [ Time Frame: Up to 7 years ] [ Designated as safety issue: No ]Will be compared by chi-square test.
- Tumor response duration [ Time Frame: 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 ] [ Designated as safety issue: No ]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.
- Metastasis-free survival [ Time Frame: From randomization until metastasis documented by imaging procedures, assessed up to 7 years ] [ Designated as safety issue: No ]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.
| Enrollment: | 756 |
| Study Start Date: | March 2000 |
| Primary Completion Date: | February 2007 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 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. |
Drug: shark cartilage extract AE-941
Given orally
Other Names:
Drug: cisplatin
Given IV
Other Names:
Drug: vinorelbine tartrate
Given IV
Other Names:
Drug: carboplatin
Given IV
Other Names:
Drug: paclitaxel
Given IV
Other Names:
Radiation: radiation therapy
Undergo radiotherapy
Other Names:
|
|
Placebo Comparator: 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. |
Other: placebo
Given orally
Other Name: PLCB
Drug: cisplatin
Given IV
Other Names:
Drug: vinorelbine tartrate
Given IV
Other Names:
Drug: carboplatin
Given IV
Other Names:
Drug: paclitaxel
Given IV
Other Names:
Radiation: radiation therapy
Undergo radiotherapy
Other Names:
|
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and LocationsPlease refer to this study by its ClinicalTrials.gov identifier: NCT00005838
| United States, Texas | |
| M D Anderson Cancer Center | |
| Houston, Texas, United States, 77030 | |
| Principal Investigator: | Charles Lu | M.D. Anderson Cancer Center |
More Information
No publications provided
| Responsible Party: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00005838 History of Changes |
| Other Study ID Numbers: | NCI-2012-02725, ID99-303, U10CA045809, CDR0000067853 |
| Study First Received: | June 2, 2000 |
| Last Updated: | January 22, 2013 |
| Health Authority: | United States: Food and Drug Administration |
Additional relevant MeSH terms:
|
Carcinoma, Non-Small-Cell Lung Lung Neoplasms Bronchial Neoplasms Carcinoma, Bronchogenic Lung Diseases Neoplasms Neoplasms by Site Respiratory Tract Diseases |
Respiratory Tract Neoplasms Thoracic Neoplasms Carboplatin Vinorelbine Antineoplastic Agents Antineoplastic Agents, Phytogenic Pharmacologic Actions Therapeutic Uses |
ClinicalTrials.gov processed this record on March 03, 2015