Clinical trial · Interventional
Pemetrexed Disodium Plus Gemcitabine in Treating Patients With Locally Advanced or Metastatic Non-Small Cell Lung Cancer
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Lung Cancer | Malignant Lung Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| gemcitabine hydrochloride | Drug | Gemcitabine | ALIAS |
| pemetrexed disodium | Drug | Pemetrexed | ALIAS |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- Arm I: pemetrexed + gemcitabine
- description
- Patients receive pemetrexed disodium IV over 10 minutes on day 1 followed by gemcitabine IV over 30 minutes on days 1 and 8.
- interventionNames
- Drug: gemcitabine hydrochloride
- Drug: pemetrexed disodium
- type
- EXPERIMENTAL
- label
- Arm II: pemetrexed + gemcitabine
- description
- Patients receive gemcitabine IV over 30 minutes on days 1 and 8 followed by pemetrexed disodium IV over 10 minutes on day 1.
- interventionNames
- Drug: gemcitabine hydrochloride
- Drug: pemetrexed disodium
- type
- EXPERIMENTAL
- label
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (5)
- BACKGROUNDAn 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. PMID 21880789
- BACKGROUNDCampbell 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.
- BACKGROUNDJatoi 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. doi: 10.1200/JCO.2005.03.7465. PMID 16361618
- RESULTAdjei AA, Salavaggione OE, Mandrekar SJ, Dy GK, Ziegler KL, Endo C, Molina JR, Schild SE, Adjei AA. Correlation between polymorphisms of the reduced folate carrier gene (SLC19A1) and survival after pemetrexed-based therapy in non-small cell lung cancer: a North Central Cancer Treatment Group-based exploratory study. J Thorac Oncol. 2010 Sep;5(9):1346-53. doi: 10.1097/JTO.0b013e3181ec18c4. PMID 20651609
- RESULTMa CX, Nair S, Thomas S, Mandrekar SJ, Nikcevich DA, Rowland KM, Fitch TR, Windschitl HE, Hillman SL, Schild SE, Jett JR, Obasaju C, Adjei AA; North Central Cancer Treatment Group; Mayo Clinic; Eli Lilly & Company. Randomized phase II trial of three schedules of pemetrexed and gemcitabine as front-line therapy for advanced non-small-cell lung cancer. J Clin Oncol. 2005 Sep 1;23(25):5929-37. doi: 10.1200/JCO.2005.13.953. PMID 16135464