Pemetrexed Disodium Plus Gemcitabine in Treating Patients With Locally Advanced or Metastatic Non-Small Cell Lung Cancer

• Sponsor: Alliance for Clinical Trials in Oncology (Other)
• Overall Status: Completed
• CT.gov ID: NCT00022646
• Collaborator: National Cancer Institute (NCI) (NIH)
• Enrollment: 157
• Locations: 22
• Arms: 3
• Duration (Months): 86
• Patients Per Site: 7.1
• Patients Per Site Per Month: 0.1

Study Details

Study Description

Brief Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Giving more than one drug and giving the drugs in different ways may kill more tumor cells.

PURPOSE: Randomized phase II trial to compare the effectiveness of three different regimens of pemetrexed disodium plus gemcitabine in treating patients who have locally advanced or metastatic non-small cell lung cancer.

Condition or Disease	Intervention/Treatment	Phase
Lung Cancer	Drug: gemcitabine hydrochloride; Drug: pemetrexed disodium	Phase 2

Detailed Description

OBJECTIVES:

• Compare the tumor response rates in patients with locally advanced or metastatic non-small cell lung cancer treated with 3 different schedules of pemetrexed disodium and gemcitabine.

• Compare the duration of response, time to progressive disease, time to treatment failure, and survival time in patients treated with these regimens.

• Compare the quantitative and qualitative toxic effects of these regimens in these patients.

OUTLINE: This is a randomized, open-label study. Patients are stratified according to stage of disease (IIIB vs IV) and ECOG performance status (0 vs 1). Patients are randomized to one of three treatment arms.

• Arm I: Patients receive pemetrexed disodium IV over 10 minutes on day 1 followed by gemcitabine IV over 30 minutes on days 1 and 8.

• Arm II: Patients receive gemcitabine IV over 30 minutes on days 1 and 8 followed by pemetrexed disodium IV over 10 minutes on day 1.

• Arm III: Patients receive gemcitabine IV over 30 minutes on day 1 and pemetrexed disodium IV over 10 minutes followed by gemcitabine IV over 30 minutes on day 8.

Treatment repeats every 21 days for 2 courses in the absence of disease progression or unacceptable toxicity. Patients with stable or responding disease may receive up to 6 additional courses of therapy.

Patients are followed every 2 months for 1 year and then every 6 months for 4 years.

PROJECTED ACCRUAL: A total of 180 patients (60 per treatment arm) will be accrued for this study within 20 months.

Study Design

• Study Type: Interventional
• Actual Enrollment: 157 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Phase II Clinical Trial Evaluating Three Schedules Of ALIMTA Plus Gemcitabine As Frontline Chemotherapy For Patients With Locally Advanced Or Metastatic Non-Small Cell Lung Cancer
• Study Start Date: Aug 1, 2001
• Actual Primary Completion Date: Nov 1, 2003
• Actual Study Completion Date: Oct 1, 2008

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Arm I: pemetrexed + gemcitabine Patients receive pemetrexed disodium IV over 10 minutes on day 1 followed by gemcitabine IV over 30 minutes on days 1 and 8.	Drug: gemcitabine hydrochloride; Drug: pemetrexed disodium
Experimental: Arm II: pemetrexed + gemcitabine Patients receive gemcitabine IV over 30 minutes on days 1 and 8 followed by pemetrexed disodium IV over 10 minutes on day 1.	Drug: gemcitabine hydrochloride; Drug: pemetrexed disodium
Experimental: Arm III: pemetrexed + gemcitabine Patients receive gemcitabine IV over 30 minutes on day 1 and pemetrexed disodium IV over 10 minutes followed by gemcitabine IV over 30 minutes on day 8.	Drug: gemcitabine hydrochloride; Drug: pemetrexed disodium

Outcome Measures

Primary Outcome Measures

1. tumor response rate [Up to 4 years]

Secondary Outcome Measures

1. duration of response [Up to 4 years]

2. time to treatment failure [Up to 4 years]

3. survival [Up to 4 years]

4. time to disease progression [Up to 4 years]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

DISEASE CHARACTERISTICS:

• Histologically or cytologically confirmed locally advanced or metastatic non-small cell lung cancer

• Stage IIIB disease that is ineligible for combined modality therapy OR

• Stage IV disease

• Measurable disease

• No clinically detectable (by physical exam) third-space fluid collection (e.g., ascites or pleural effusions) that cannot be controlled by drainage or other procedures

• No brain metastases (even if treated)

PATIENT CHARACTERISTICS:

Age:

• 18 and over

Performance status:

• ECOG 0-1

Life expectancy:

• At least 12 weeks

Hematopoietic:

• Absolute neutrophil count at least 1,500/mm^3

• Platelet count at least 100,000/mm^3

• Hemoglobin at least 9 g/dL

Hepatic:

• Bilirubin no greater than 1.5 times upper limit of normal (ULN)

• AST and ALT no greater than 3 times ULN (5 times ULN if liver metastases present)

• Alkaline phosphatase no greater than 3 times ULN (5 times ULN if liver metastases present)

Renal:

• Creatinine clearance at least 45 mL/min

Other:

• Not pregnant or nursing

• Negative pregnancy test

• Fertile patients must use effective contraception

• Able to take folic acid or cyanocobalamin (vitamin B12) supplementation

• No uncontrolled infection

• No concurrent chronic debilitating disease

• No weight loss of 10% or more within the past 6 weeks

• No other prior malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer or noninvasive carcinoma

PRIOR CONCURRENT THERAPY:

Biologic therapy:

• No prior biologic or genetic therapy for lung cancer

• No concurrent immunomodulating agents

Chemotherapy:

• No prior chemotherapy for lung cancer

Endocrine therapy:

• Not specified

Radiotherapy:

• At least 4 weeks since prior radiotherapy to a different site and recovered

• No prior radiotherapy to 25% or more of bone marrow

• No prior radiotherapy to whole pelvis

• No prior radiotherapy for primary disease

• No concurrent radiotherapy

Surgery:

• More than 4 weeks since prior major surgery

Other:

• No aspirin or nonsteroidal anti-inflammatory agents 2 days before, during, and for 2 days after pemetrexed disodium administration (5 days for long-acting agents such as piroxicam, naproxen, diflunisal, or nabumetone)

• No other concurrent cytostatic or cytotoxic therapy

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	CCOP - Scottsdale Oncology Program	Scottsdale	Arizona	United States	85259-5404
2	Mayo Clinic	Jacksonville	Florida	United States	32224
3	CCOP - Illinois Oncology Research Association	Peoria	Illinois	United States	61602
4	CCOP - Carle Cancer Center	Urbana	Illinois	United States	61801
5	CCOP - Cedar Rapids Oncology Project	Cedar Rapids	Iowa	United States	52403-1206
6	CCOP - Iowa Oncology Research Association	Des Moines	Iowa	United States	50309-1016
7	Siouxland Hematology-Oncology	Sioux City	Iowa	United States	51101-1733
8	CCOP - Wichita	Wichita	Kansas	United States	67214-3882
9	CCOP - Ann Arbor Regional	Ann Arbor	Michigan	United States	48106
10	CCOP - Duluth	Duluth	Minnesota	United States	55805
11	Mayo Clinic Cancer Center	Rochester	Minnesota	United States	55905
12	CentraCare Health Plaza	Saint Cloud	Minnesota	United States	56303
13	CCOP - Metro-Minnesota	Saint Louis Park	Minnesota	United States	55416
14	CCOP - Missouri Valley Cancer Consortium	Omaha	Nebraska	United States	68106
15	Medcenter One Health System	Bismarck	North Dakota	United States	58501
16	CCOP - Merit Care Hospital	Fargo	North Dakota	United States	58122
17	Altru Health Systems	Grand Forks	North Dakota	United States	58201
18	CCOP - Toledo Community Hospital	Toledo	Ohio	United States	43623-3456
19	CCOP - Geisinger Clinic and Medical Center	Danville	Pennsylvania	United States	17822-2001
20	Allegheny General Hospital	Pittsburgh	Pennsylvania	United States	15212-4772
21	Rapid City Regional Hospital	Rapid City	South Dakota	United States	57709
22	CCOP - Sioux Community Cancer Consortium	Sioux Falls	South Dakota	United States	57104

Sponsors and Collaborators

• Alliance for Clinical Trials in Oncology
• National Cancer Institute (NCI)

Investigators

• Study Chair: Alex A. Adjei, MD, PhD, Mayo Clinic

Study Documents (Full-Text)

None provided.

More Information

Publications

• An MW, Mandrekar SJ, Branda ME, Hillman SL, Adjei AA, Pitot HC, Goldberg RM, Sargent DJ. Comparison of continuous versus categorical tumor measurement-based metrics to predict overall survival in cancer treatment trials. Clin Cancer Res. 2011 Oct 15;17(20):6592-9. doi: 10.1158/1078-0432.CCR-11-0822. Epub 2011 Aug 31.
• Campbell ME, Mandrekar SJ, Hillman SL, et al.: What is the added value of actual tumor measurements (TM) in predicting overall survival (OS)? The North Central Cancer Treatment Group (NCCTG) findings. [Abstract] J Clin Oncol 26 (Suppl 15): A-6520, 2008.
• Jatoi A, Hillman S, Stella P, Green E, Adjei A, Nair S, Perez E, Amin B, Schild SE, Castillo R, Jett JR; North Central Cancer Treatment Group. Should elderly non-small-cell lung cancer patients be offered elderly-specific trials? Results of a pooled analysis from the North Central Cancer Treatment Group. J Clin Oncol. 2005 Dec 20;23(36):9113-9.

• Responsible Party: Alliance for Clinical Trials in Oncology
• ClinicalTrials.gov Identifier: NCT00022646
• Other Study ID Numbers: NCCTG-N0026; NCI-2012-02399; CDR0000068838
• First Posted: Jan 27, 2003
• Last Update Posted: Dec 7, 2016
• Last Verified: Dec 1, 2016

• Keywords provided by Alliance for Clinical Trials in Oncology: stage IIIB non-small cell lung cancer; stage IV non-small cell lung cancer
• Additional relevant MeSH terms: Lung Neoplasms; Carcinoma, Non-Small-Cell Lung; Gemcitabine; Pemetrexed

Study Results

No Results Posted as of Dec 7, 2016