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Phase I/II Trial of Abraxane® (ABI-007) and Alimta® (Pemetrexed) in Advanced Solid Tumors With Emphasis on Non-Small Cell Lung Cancer (NSCLC) and Breast Cancer

Phase 1/Phase 2
18 Years
Open (Enrolling)
Breast Cancer, Lung Cancer, Unspecified Adult Solid Tumor, Protocol Specific

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Trial Information

Phase I/II Trial of Abraxane® (ABI-007) and Alimta® (Pemetrexed) in Advanced Solid Tumors With Emphasis on Non-Small Cell Lung Cancer (NSCLC) and Breast Cancer



- Determine the safety and feasibility of paclitaxel albumin-stabilized nanoparticle
formulation when administered with pemetrexed disodium in patients with advanced
non-small cell lung cancer, breast cancer, or other solid tumors. (Phase I)

- Determine the efficacy of this regimen, as measured by objective tumor response rate
(RECIST criteria), in these patients. (Phase II)


- Determine the maximum tolerated dose of this regimen in these patients. (Phase I)

- Determine the preliminary efficacy of paclitaxel albumin-stabilized nanoparticle
formulation and pemetrexed disodium in these patients. (Phase I)

- Determine the progression-free survival and overall survival of patients treated with
this regimen. (Phase II)

- Evaluate the frequency and severity of toxicities associated with this regimen. (Phase

OUTLINE: This is a phase I, dose-escalation study of paclitaxel albumin-stabilized
nanoparticle formulation followed by an open-label, phase II study.

- Phase I: Patients receive pemetrexed disodium IV over 10 minutes and paclitaxel
albumin-stabilized nanoparticle formulation IV over 30 minutes on day 1. Treatment
repeats every 21 days for up to 6 courses in the absence of disease progression or
unacceptable toxicity.

Cohorts of 3-6 patients receive escalating doses of paclitaxel albumin-stabilized
nanoparticle formulation until the maximum tolerated dose (MTD) is determined. The MTD is
defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience
dose-limiting toxicity.

- Phase II: Patients receive pemetrexed disodium and paclitaxel albumin-stabilized
nanoparticle formulation at the MTD as in phase I.

After completion of study treatment, patients are followed periodically.

PROJECTED ACCRUAL: A total of 73 patients will be accrued for this study.

Inclusion Criteria

Inclusion Criteria

1. For the phase II portion patients must have cytologically or histologically proven
selected stage IIIB (pleural effusion) or IV NSCLC.

2. For the phase II portion patients must have NSCLC that has progressed or recurred
after treatment with platinum-based therapy.

3. No prior pemetrexed. Prior Taxol is allowed. Prior ABI 007 is not allowed.

4. Patients must have measurable disease by RECIST criteria for the phase II portion.

5. Patients must be 18 years of age or older.

6. Patients must have a performance status of 0 -2

7. Patients must have an estimated survival of at least 3 months.

8. Any prior chemotherapy must have been completed at least 4 weeks prior to start of

9. Patients must have adequate renal function as documented by a calculated creatinine
clearance of > 45 ml/min

10. Patients must have adequate liver functions: AST and ALT < 2.5 X upper limit of
normal, and bilirubin < upper limit of normal.

11. Patients must have adequate bone marrow function: Platelets >100,000 cells/mm3 and
ANC > 1,500 cells/mm3.

12. For patients who have baseline clinically significant pleural or peritoneal effusions
(on the basis of symptoms or clinical examination) before initiation of pemetrexed
therapy, consideration should be given to draining the effusion prior to dosing.

13. Patients with asymptomatic treated brain metastasis (surgical resection or
radiotherapy) may be included if they are neurologically stable and have been off
steroids and anticonvulsants for at least 4 weeks.

14. Patients must be able to take and retain oral medication.

15. Ability to take folic acid, vitamin B12 and dexamethasone according to protocol.

16. Ability to interrupt NSAIDS 2 days before, the day of, and 2 days following
administration of pemetrexed.

17. Patients of reproductive potential must agree to use effective contraceptive method
while on treatment and for 3 months afterwards as the effects of these drugs on the
unborn fetus are unknown.

18. No other current active malignancy.

19. Patient or his/her legally authorized representative or guardian signed the Informed
Consent form prior to participation in any study-related activities.

Exclusion Criteria

1. Pregnant or breastfeeding women.

2. Patient with pre-existing peripheral neuropathy of NCI CTCAE Version 3.0 of grade 2.

3. Patient has a clinically significant concurrent illness.

4. Patient is currently enrolled in a different clinical study in which investigational
procedures are performed or investigational therapies are administered.

5. Patient has a history of allergy or hypersensitivity to the study drugs or a taxane.

6. Patient has serious medical risk factors involving any of the major organ systems
such that the investigator considers it unsafe for the patient to receive an
experimental research drug.

7. Prior therapy with pemetrexed, or ABI-007.

8. Patient is receiving treatment with any excluded concomitant medication.

9. Presence of third space fluid which cannot be controlled by drainage.

Type of Study:


Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Phase I: Safety combining ABI-007 with pemetrexed in patients with advanced solid tumors

Outcome Description:

Measure toxicities using CTCAE 3.0

Outcome Time Frame:

Toxicity will be assessed on day 8, 15 and subsequently at the beginning of every cycle.

Safety Issue:


Principal Investigator

David R. Gandara, MD

Investigator Role:

Study Chair

Investigator Affiliation:

University of California, Davis


United States: Food and Drug Administration

Study ID:




Start Date:

April 2007

Completion Date:

December 2015

Related Keywords:

  • Breast Cancer
  • Lung Cancer
  • Unspecified Adult Solid Tumor, Protocol Specific
  • male breast cancer
  • recurrent breast cancer
  • stage IIIA breast cancer
  • stage IIIB breast cancer
  • stage IIIC breast cancer
  • stage IV breast cancer
  • stage IIIA non-small cell lung cancer
  • stage IIIB non-small cell lung cancer
  • stage IV non-small cell lung cancer
  • recurrent non-small cell lung cancer
  • unspecified adult solid tumor, protocol specific
  • Breast Neoplasms
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms
  • Neoplasms



University of California Davis Cancer Center Sacramento, California  95817