Docetaxel and Cisplatin With or Without Dimesna in Treating Patients With Stage IIIB or Stage IV Non-Small Cell Lung Cancer
This study has been completed.
Sponsor:
Cancer and Leukemia Group B
Collaborator:
Information provided by:
Cancer and Leukemia Group B
ClinicalTrials.gov Identifier:
NCT00077311
First received: February 10, 2004
Last updated: April 6, 2011
Last verified: April 2011
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
RATIONALE: Drugs used in chemotherapy, such as docetaxel and cisplatin, work in different ways to stop tumor cells from dividing so they stop growing or die. Chemoprotective drugs, such as dimesna, may help prevent or decrease the side effects (such as nerve, kidney, and inner ear damage) caused by chemotherapy.
PURPOSE: This randomized phase II trial is studying giving docetaxel and cisplatin together with dimesna to see how well it works compared to giving docetaxel and cisplatin alone in treating patients with stage IIIB or stage IV non-small cell lung cancer.
| Condition | Intervention | Phase |
|---|---|---|
|
Anemia Drug/Agent Toxicity by Tissue/Organ Lung Cancer Neutropenia |
Biological: darbepoetin alfa Biological: pegfilgrastim Drug: cisplatin Drug: docetaxel Drug: BNP7787 |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Phase II Randomized Study Of Dose-Dense Docetaxel And Cisplatin Every Two Weeks With Pegfilgrastim And Darbepoetin Alfa With And Without The Chemoprotector BNP7787 In Patients With Advanced Non-Small Cell Lung Cancer |
Resource links provided by NLM:
Further study details as provided by Cancer and Leukemia Group B:
Primary Outcome Measures:
- Toxicity [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]Toxicity profile w/ emphasis on incidence and severity of peripheral neuropathy, febrile neutropenia, and nephrotoxicity
Secondary Outcome Measures:
- Response [ Time Frame: during tx,q 3 mon for 1 yr, then q 6 mon for 2 yrs ] [ Designated as safety issue: No ]
- Survival [ Time Frame: q 6 mon for 2 yrs after registration, then annually ] [ Designated as safety issue: No ]
| Enrollment: | 160 |
| Study Start Date: | August 2004 |
| Study Completion Date: | April 2009 |
| Primary Completion Date: | July 2006 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Chemotherapy without BNP7787
Chemotherapy with dose-dense docetaxel and cisplatin with pegfilgrastim and darbepoetin for pts with NSCLC
|
Biological: darbepoetin alfa
200 mcg sub Q on day 1 of each cycle if HgB < or = 11 g/dL
Biological: pegfilgrastim
6 mg sub Q day 2 of each cycle
Drug: cisplatin
75 mg/sq m IV over 1 hr Day 1 of each cycle
Drug: docetaxel
75 mg/sq m IV over 1 hr Day 1 of each cycle
|
|
Experimental: Chemotherapy + BNP7787
Chemotherapy with dose-dense docetaxel and cisplastin with pegfilgrastim and darbepoetin with the addition of BNP7787
|
Biological: darbepoetin alfa
200 mcg sub Q on day 1 of each cycle if HgB < or = 11 g/dL
Biological: pegfilgrastim
6 mg sub Q day 2 of each cycle
Drug: cisplatin
75 mg/sq m IV over 1 hr Day 1 of each cycle
Drug: docetaxel
75 mg/sq m IV over 1 hr Day 1 of each cycle
Drug: BNP7787
40 g IV over 30 min Day 1 of each cycle
|
Detailed Description:
OBJECTIVES:
Primary
- Compare the incidence and severity of peripheral neuropathy in patients with stage IIIB or IV non-small cell lung cancer treated with docetaxel and cisplatin with or without dimesna.
- Compare the feasibility of these regimens, in terms of febrile neutropenia and treatment delays, in these patients.
- Compare the objective response rate in patients treated with these regimens.
Secondary
- Compare the survival and failure-free survival of patients treated with these regimens.
- Compare the toxicity profile of these regimens in these patients.
- Compare the incidence and severity of cisplatin-induced nephrotoxicity in patients treated with these regimens.
OUTLINE: This is a randomized, multicenter study. Patients are randomized to 1 of 2 treatment arms.
- Arm I*: Patients receive docetaxel IV over 1 hour and cisplatin IV over 1 hour on day 1 and pegfilgrastim subcutaneously (SC) on day 2.
- Arm II*: Patients receive docetaxel, cisplatin, and pegfilgrastim as in arm I and dimesna IV over 30 minutes on day 1.
NOTE: *In both arms, darbepoetin alfa is administered SC on day 1 of each course for hemoglobin ≤ 11 g/dL.
In both arms, treatment repeats every 2 weeks for a total of 6 courses in the absence of disease progression or unacceptable toxicity.
Patients are followed every 3 months for 1 year and then every 6 months for 2 years.
PROJECTED ACCRUAL: A total of 152 patients (76 per treatment arm) will be accrued for this study within 18-20 months.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
DISEASE CHARACTERISTICS:
Histologically or cytologically confirmed* non-small cell lung cancer of 1 of the following subtypes:
- Squamous carcinoma
- Basaloid carcinoma
- Adenocarcinoma
- Bronchoalveolar carcinoma
- Adenosquamous carcinoma
- Large cell carcinoma
- Large cell neuroendocrine carcinoma
- Giant cell carcinoma
- Sarcomatoid carcinoma
- Non-small cell carcinoma not otherwise specified NOTE: *Histologic or cytologic confirmation of recurrence is required for patients who have undergone prior complete resection
- Stage IIIB disease due to malignant pleural effusion OR stage IV disease
Measurable disease
- At least 1 unidimensionally measurable lesion at least 20 mm by conventional techniques OR at least 10 mm by spiral CT scan
The following are considered nonmeasurable disease:
- Bone lesions
- Brain metastases or leptomeningeal disease
- Ascites
- Pleural/pericardial effusion
- Abdominal masses not confirmed and followed by imaging techniques
- Cystic lesions
- Tumor lesions situated in a previously irradiated area
- Brain metastases are allowed provided patient is neurologically stable and off steroids
PATIENT CHARACTERISTICS:
Age
- 18 and over
Performance status
- ECOG 0-1
Life expectancy
- Not specified
Hematopoietic
- Granulocyte count ≥ 1,500/mm^3
- Platelet count ≥ 100,000/mm^3
Hepatic
- Bilirubin ≤ 1.5 mg/dL
- AST ≤ 1.5 times upper limit of normal (ULN)
- Alkaline phosphatase ≤ 2.5 times ULN
Renal
- Creatinine ≤ ULN
Other
- Not pregnant or nursing
- Fertile patients must use effective contraception
- No grade 2 or greater neuropathy
PRIOR CONCURRENT THERAPY:
Biologic therapy
- No other concurrent growth factors
Chemotherapy
- No prior chemotherapy
- No other concurrent chemotherapy
Endocrine therapy
- See Disease Characteristics
- No concurrent hormonal therapy except steroids administered for adrenal failure, hormones for non-cancer-related conditions (e.g., insulin for diabetes), or intermittent dexamethasone as an antiemetic
Radiotherapy
- See Disease Characteristics
- Prior radiotherapy allowed for brain metastases only
- No concurrent palliative radiotherapy
Surgery
- See Disease Characteristics
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00077311
Show 64 Study Locations
Show 64 Study LocationsSponsors and Collaborators
Cancer and Leukemia Group B
Investigators
| Study Chair: | Antonius A. Miller, MD | Comprehensive Cancer Center of Wake Forest University |
More Information
Additional Information:
Publications:
Green MR, Miller AA, Wang XF, et al.: Phase II randomized study of dose-dense docetaxel (Doc) and cisplatin (Cis) every two weeks with pegfilgrastim (Pfil) and darbepoetin alfa (Darb) with and without the chemoprotector BNP7787 in patients with advanced non-small cell lung cancer (NSCLC): CAL. [Abstract] J Clin Oncol 25 (Suppl 18): A-7617, 413s, 2007.
| Responsible Party: | Monica M Bertagnolli, MD, Cancer and Leukemia Group B |
| ClinicalTrials.gov Identifier: | NCT00077311 History of Changes |
| Other Study ID Numbers: | CDR0000350089, U10CA031946, CALGB-30303 |
| Study First Received: | February 10, 2004 |
| Last Updated: | April 6, 2011 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Cancer and Leukemia Group B:
|
drug/agent toxicity by tissue/organ anemia neutropenia stage IV non-small cell lung cancer stage IIIB non-small cell lung cancer recurrent non-small cell lung cancer |
squamous cell lung cancer large cell lung cancer adenocarcinoma of the lung bronchoalveolar cell lung cancer adenosquamous cell lung cancer |
Additional relevant MeSH terms:
|
Anemia Carcinoma, Non-Small-Cell Lung Lung Neoplasms Neutropenia Hematologic Diseases Carcinoma, Bronchogenic Bronchial Neoplasms Respiratory Tract Neoplasms Thoracic Neoplasms Neoplasms by Site Neoplasms Lung Diseases Respiratory Tract Diseases |
Agranulocytosis Leukopenia Leukocyte Disorders Docetaxel Cisplatin Darbepoetin alfa Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Radiation-Sensitizing Agents Physiological Effects of Drugs Hematinics Hematologic Agents |
ClinicalTrials.gov processed this record on June 18, 2013