Clinical Research Details

A Randomized Phase II Trial of Weekly Topotecan With and Without AVE0005 (Aflibercept; NSC-724770) in Patients With Platinum Treated Extensive Stage Small Cell Lung Cancer (E-SCLC)

The purpose of this study is to evaluate the efficacy of weekly topotecan as a single agent and the combination of AVE0005 and weekly topotecan in previously treated platinum-sensitive and platinum refractory patients with extensive stage small cell lung cancer (E-SCLC) in terms of progression-free survival (PFS) at three months.

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Patients must have a histologically or cytologically confirmed diagnosis of extensive stage small cell lung cancer (E-SCLC) as defined in Section 4.1 with progression or recurrence after receiving exactly one standard first-line platinum-containing regimen (cisplatin or carboplatin). Patients will be stratified by platinum sensitivity status as outlined in Section 6.0.

Patients may have measurable or non-measurable disease per RECIST (Section 10.1). Disease must be evident on CT scan or MRI scan. The CT from a combined PET/CT must not be used to document measurable disease unless it is of diagnostic quality as defined in Section 10.1a. All scans to assess measurable disease must have been performed within 28 days prior to registration. Non-measurable disease must be assessed within 42 days prior to registration. All disease must be assessed and documented on the Baseline Tumor Assessment Form (Form #9570).

Patients with known brain metastases are eligible only if he/she has been treated and stable for at least three months prior to study entry. Only a non-enzyme-inducing anticonvulsant (e.g., Keppra) will be permitted for those patients requiring anticonvulsants. Patients must not have leptomeningeal involvement or brain stem metastases. All patients must have a pretreatment CT or MRI scan of the brain to evaluate CNS disease within 28 days prior to registration.

Patients may have received prior radiation therapy provided at least 21 days since the completion of prior radiation therapy, and patients must have recovered from all associated toxicities at the time of registration. Measurable or non-measurable disease must be present outside the previous radiation field, or a new lesion inside the port must be present. There must be no anticipated need for concurrent radiation therapy during protocol treatment.

Patients may have received prior surgery provided that at least 28 days have elapsed since surgery (thoracic or other major surgeries), and patients must have recovered from all associated toxicities at the time of registration. There must be no anticipated need for major surgical procedures during protocol treatment. Patients must have disease outside of the previous surgical resection area or a new lesion must be present.

Patients must not have had prior exposure to bevacizumab or other anti-angiogenic therapies (including but not limited to small molecule tyrosine kinase inhibitors).

All patients must have a Zubrod Performance Status of 0-1 (see Section 10.4).

All patients must be 18 years of age or older.

If you are in Group 1, you will receive the drug AVE0005 in a vein in your arm over one hour on Day 1 along with topotecan in a vein in your arm over 30 minutes on Days 1, 8 and 15 of each treatment cycle. Treatment cycles will be three weeks long. If, at the end of four cycles (12 weeks), your doctor thinks that your disease has responded to study treatment, topotecan will be given on Days 1 and 8 every three weeks, but AVE0005 will continue to be given on Day 1 every three weeks. The cycles will be repeated as long as you are tolerating the treatment and your disease does not get worse. All treatment can be given as an outpatient.

If you are in Group 2, you will receive the drug topotecan in a vein in your arm over 30 minutes on Days 1, 8, and 15 of each treatment cycle. Treatment cycles will be three weeks long. If, at the end of four cycles (12 weeks), your doctor thinks that your disease has responded to study treatment, topotecan will be given on Days 1 and 8 every three weeks. The cycles will be repeated as long as you are tolerating the treatment and your disease does not get worse. All treatment can be given as an outpatient.

Danielle Shafer, D.O.

(708) 327-3229