Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outcomes
Outline
Published Results
Trial Contact Information
Registry Information

Alternate Title

Docetaxel and Cisplatin With or Without Dimesna in Treating Patients With Stage IIIB or Stage IV Non-Small Cell Lung Cancer

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase II	Supportive care, Treatment	Completed	18 and over	NCI	CALGB-30303 NCT00077311

Objectives

Primary

1. 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.
2. Compare the feasibility of these regimens, in terms of febrile neutropenia and treatment delays, in these patients.
3. Compare the objective response rate in patients treated with these regimens.

Secondary

1. Compare the survival and failure-free survival of patients treated with these regimens.
2. Compare the toxicity profile of these regimens in these patients.
3. Compare the incidence and severity of cisplatin-induced nephrotoxicity in patients treated with these regimens.

Entry 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

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

Patient Characteristics:

Age

• 18 and over

Performance status

• ECOG 0-1

Life expectancy

• Not specified

Hematopoietic

• Granulocyte count ≥ 1,500/mm³
• Platelet count ≥ 100,000/mm³

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

Expected Enrollment

A total of 152 patients (76 per treatment arm) will be accrued for this study within 18-20 months.

Outcomes

Incidence and severity of peripheral neuropathy
Feasibility
Objective response rate

Survival and failure-free survival
Toxicity
Incidence and severity of cisplatin-induced nephrotoxicity

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.

Miller AA, Wang XF, Gu L, et al.: Phase II randomized study of dose-dense docetaxel and cisplatin every 2 weeks with pegfilgrastim and darbepoetin alfa with and without the chemoprotector BNP7787 in patients with advanced non-small cell lung cancer (CALGB 30303). J Thorac Oncol 3 (10): 1159-65, 2008.[PUBMED Abstract]

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.

Trial Contact Information

Trial Lead Organizations

Cancer and Leukemia Group B

Antonius Miller, MD, Protocol chair		Ph: 336-713-4392; 800-446-2255

Registry Information
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
Trial Start Date		2006-08-15
Trial Completion Date		2008-11-04
Registered in ClinicalTrials.gov		NCT00077311
Date Submitted to PDQ		2003-12-17
Information Last Verified		2006-03-16
NCI Grant/Contract Number		U10-CA31946

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